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ProteoNic Announces Partnership with Ginkgo Bioworks and Joins the Ginkgo Technology Network

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LEIDEN, the Netherlands, March 13, 2024 / Biotech Newswire / -- ProteoNic Biosciences, a leading provider of premium vector technology and services for the production of biologics, today announced a partnership with Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity. This strategic alliance will grant Ginkgo Bioworks’ customers access to ProteoNic's state of the art vector technology in the field of protein production as well as to novel viral vector technology for cell and gene therapy applications. This also marks ProteoNic’s joining the Ginkgo Technology Network, a groundbreaking ecosystem of cutting-edge technology partners dedicated to driving innovation in customer R&D programs.

"This collaboration opens a significant opportunity for ProteoNic and its customers,” says Frank Pieper, ProteoNic’s CEO. "This partnership seamlessly aligns with our core mission of supporting our clients in enabling production of complex biologics, driving capacity enhancements and achieving cost-of-goods savings in biologics manufacturing, while also tackling critical hurdles in viral vector manufacturing for cell and gene therapies."

ProteoNic's premium vector technology is broadly applicable across cell lines and product classes, including complex molecules which are difficult to express by conventional technology. Application of this novel technology enables production of complex molecules at economically viable levels, resolves capacity constraints and reduces manufacturing costs. Applied to viral vectors, it has the capacity to resolve bottlenecks currently associated with LV and AAV production.

The Ginkgo Technology Network brings together a diverse array of partners, spanning AI, genetic medicines, biologics, and manufacturing, with the aim of integrating their capabilities to provide customers with robust end-to-end solutions for successful R&D outcomes.

"I’ve known and admired the ProteoNic team for several years and am thrilled to welcome them to the Ginkgo Technology Network," said Anna Marie Wagner, Ginkgo’s SVP, Head of AI and Corporate Development. "Their expertise and premium technology adds tremendous value to our network, enhancing our ability to provide comprehensive solutions to our customers across various biotech sectors."

 

About ProteoNic BV
ProteoNic is a privately held company with offices in Leiden, the Netherlands and in the Boston area, USA. The company offers technology and services for the generation of cell lines and viral vectors with greatly improved production characteristics. The company commercializes its proprietary 2G UNic® technology through licensing and partnership arrangements.

About Ginkgo Bioworks
Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect and respond to a wide variety of biological threats. For more information, visit www.ginkgobioworks.com and www.concentricbyginkgo.com, read our blog, or follow us on social media channels such as X (formerly known as Twitter) (@Ginkgo and @ConcentricByGBW), Instagram (@GinkgoBioworks), Threads (@GinkgoBioworks) or LinkedIn.

 

Contact

ProteoNic BV
Mark Posno, PhD
Vice President Business Development
+1 617 480 8016
posno@proteonic.nl

 

Keywords: International Cooperation; Genetic Vectors; Genetic Therapy; Cell- and Tissue-Based Therapy; Regenerative Medicine; Biological Products; Industry; Biotechnology; Technology; Netherlands; ProteoNic Biosciences; Ginkgo Bioworks; Partnership; Ginkgo Technology Network; Vector technology; Novel viral vector technology; Frank Pieper; Viral vector manufacturing; Protein production; Cell lines; Manufacturing; LV (Lentivirus); AAV (Adeno-associated virus); Anna Marie Wagner; Boston area, USA; 2G UNic® technology; Licensing; Cell programming; Pharmaceuticals; Biosecurity

Published by Biotech Newswire


ProBioGen Partners with MAPP BIOPHARMACEUTICAL, INC. for Groundbreaking Development of Afucosylated Antibody Against Marburg Virus Disease Using GlymaxX Technology

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BERLIN, Germany, March 13, 2024  / Biotech Newswire / -- ProBioGen, a leading CDMO of innovative solutions and services for biopharmaceutical development, is pleased to announce the execution of services and license agreements with MAPP BIOPHARMACEUTICAL, INC. to develop a cell line for an afucosylated antibody targeting Marburg virus (MARV) infection. This collaborative effort will leverage ProBioGen's cutting-edge GlymaxX® technology to enhance the therapeutic potential of the antibody by adjusting the afucosylation levels.

Under the terms of the agreement, ProBioGen will contribute its expertise in cell line development including its proprietary DirectedLuck® transposase system and GlymaxX technology to enhance antibody-dependent cellular cytotoxicity (ADCC) of the molecule. ADCC enhancement is a key strategy for improving therapeutic antibody-drug efficacy. This collaboration aims to address the urgent need for advanced therapies against MARV infections, a severe and often fatal illness caused by the Marburg virus.

"We are excited to collaborate with MAPP BIOPHARMACEUTICAL, INC. in the development of a cell line for an afucosylated antibody targeting MARV infection, utilizing our GlymaxX technology," said Volker Sandig, CSO at ProBioGen. "This again confirms the versatility of our technology which is broadly used for cancer therapeutics but can also make a meaningful impact in the fight against life-threatening infections."

Marburg virus poses a significant public health threat, and the development of an antibody represents a promising avenue for therapeutic intervention. By reducing fucose levels in the antibody's glycan structure, GlymaxX technology enhances its effector functions, potentially improving the overall efficacy of the antibody in combating MARV infection.

MAPP BIOPHARMACEUTICAL, INC., a prominent player in the infectious disease space of the biopharmaceutical industry, brings valuable expertise and resources to the collaboration. Biomedical Advanced Research and Development Authority (BARDA) has awarded funding to MAPP to advance the development of MBP091, a single monoclonal antibody therapeutic to treat Marburg virus disease (MVD). This would be the first therapy to specifically treat MARV infections.

"We are pleased to partner with ProBioGen to develop a cell line to produce our afucosylated antibody to treat MARV infection," commented Dr. Ronald Aimes, VP, Development - Marburg at MAPP BIOPHARMACEUTICAL, INC. "This collaboration exemplifies our shared commitment to addressing unmet medical needs and underscores the potential of combining our capabilities to deliver innovative and impactful biopharmaceutical solutions for infectious diseases."

The collaboration between ProBioGen and MAPP BIOPHARMACEUTICAL, INC. represents a significant milestone in the pursuit of novel therapies against infectious diseases. Both companies remain dedicated to advancing biopharmaceutical development and contributing to the global effort to improve healthcare outcomes. Financial details of the service and non-exclusive GlymaxX license were not disclosed.

This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50122C00076.

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About Mapp Biopharmaceutical, Inc.
Mapp Biopharmaceutical, Inc. was founded in 2003 by Drs. Kevin Whaley and Larry Zeitlin to develop novel pharmaceuticals for the prevention and treatment of infectious diseases, focusing on unmet needs in global health and biodefense.

About GlymaxX
ProBioGen developed the GlymaxX technology to optimize antibody activity, notably the enhanced antibody-mediated cell killing of cancerous or infected cells (known as "ADCC" activity). GlymaxX is based on the stable introduction of a gene into producer cells that encodes for an enzyme that blocks the cells' fucose biosynthesis pathway and hence the formation of the sugar "fucose". Consequently, in the antibody-producer cells no fucose is added to the antibody's N-linked carbohydrate part. This absence of fucose in antibodies is known to greatly enhance ADCC.
As a unique feature, differentiating it from other approaches, GlymaxX can be applied to both novel or already existing antibody producer cell lines, and entire antibody expression and discovery platforms. GlymaxX does not negatively affect cellular productivity or other product characteristics. Furthermore, a GlymaxX cell line can be flexibly used to produce differently fucosylated products, depending on the upstream process: In fucose-free medium the antibody is literally afucosylated.
The same GlymaxX cell line grown in fucose-containing medium however, uses the provided fucose and produces fully fucosylated antibody. Thus, one GlymaxX cell line can be employed to produce several products: For instance ADCC-enhanced GlymaxX antibodies or wildtype-like, fully fucosylated mAbs, e. g. for a parallel Antibody-Drug-Conjugate (ADC) project. Moreover, GlymaxX has also been used to adjust the fucose level as wanted and by biosimilar-developing companies to match the originators glycoprofile. Overall, GlymaxX is simple, rapid, potent, and universally applicable to different CHO hosts and all other eukaryotic cell species. ProBioGen offers its GlymaxX technology royalty-free and non-exclusively as a service or as an individual license.

About DirectedLuck
ProBioGen's DirectedLuck transposase system combines an optimized highly active transposase and transposon with epigenetic targeting. It is equipped with a recognition domain for specific histone marks that integrates multiple copies of transgene expression units individually at genomic regions with highest transcriptional activity. As a result, it achieves exceptionally high protein expression and maximum stability in clone pools and clones. This reduces time and manual lab work for selecting superior clones for best titers, proven stability and product quality.
The DirectedLuck Transposase is compatible with genetic elements in standard expression vector design and can be used with host cell lines of different species and tissue origin. DirectedLuck delivers superior cell lines for standard mAbs and complex glycoproteins and provides additional benefits for bispecifics and virus producer cell lines where it allows gradual adjustment of relative expression levels for optimal product quality.
DirectedLuck is available for out-licensing. Furthermore, ProBioGen applies DirectedLuck as a standard tool in clients' service projects at no extra charge.

About ProBioGen
ProBioGen is a Berlin-based specialist for developing and manufacturing biopharmaceutical active ingredients, viral vectors and vaccines with applying proprietary technologies to improve product quality and features.
Combining both state-of-the-art development services, based on ProBioGen's CHO.RiGHT® expression and manufacturing platform, together with intelligent product-specific technologies yields biologics with optimized properties. Rapid and integrated cell line and process development, comprehensive analytical development and following reliable GMP manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with GMP standards (EMA/FDA).
ProBioGen has been operational for almost 30 years. At four locations in Berlin, 300 employees contribute to the creation of new therapies in medicine and groundbreaking innovations worldwide through their creative and meticulous work. ProBioGen's growth strategy is driven by the expansion of the service value chain through organic growth and potential acquisition. Diversification is a complement driver, while the focus is strict on enabling the development of biopharmaceuticals for tomorrow.
For more information about ProBioGen, follow us on LinkedIn.

 

Contacts

ProBioGen
Dr. Gabriele Schneider
Chief Business Officer
cdmo@probiogen.de

ProBioGen Press Contact
Jana Windt
Head of Marketing and Communications
press@probiogen.de

 

Keywords: International Cooperation; Marburg Virus Disease; Biological Assay; Drug Discovery; Drug Development;  CHO Cells; Cell Line; Cell Proliferation; Cell Line Development; Cells, Cultured; Recombinant Proteins; Biological Products; Antibodies; Productivity; Antibody-Dependent Cell Cytotoxicity; Fucose; Glycosylation; Killer Cells, Natural; Biosimilar Pharmaceuticals; Technology; Cell Line; Technology; Cell Culture Techniques; Culture Media; Cell Proliferation; Biological Products; Productivity; Technology; Bioreactors; Commerce; Licensure; Germany; ProBioGen; MAPP Biopharmaceutical, Inc.; Partnership; GlymaxX technology; Afucosylated antibody; Marburg virus disease (MARV); DirectedLuck transposase system; Antibody-dependent cellular cytotoxicity (ADCC); Therapeutic antibody; Infectious diseases; Biomedical Advanced Research and Development Authority (BARDA); Infectious diseases; ADCC activity; GlymaxX cell line; CHO hosts; CHO.RiGHT® expression platform; GMP manufacturing; Cell line and process development; Regulatory compliance; Therapeutic development; Biopharmaceuticals; Research and development 

Published by Biotech Newswire

Viroclinics-DDL Changes Name to Cerba Research

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ROTTERDAM, the Netherlands, March 14, 2024 / Biotech Newswire / -- Viroclinics-DDL (referred to herein as Cerba Research, the Netherlands) a world leading vaccine and antiviral specialty laboratory providing research and clinical trial solutions rooted in virology, proudly announces changing its name to Cerba Research as of the 1st of April 2024. This branding step was an expected move after the Viroclinics-DDL teams had joined Cerba Research in 2022, now operating as one company well positioned in the entire value chain of research and clinical trials.

Viroclinics-DDL, with its three specialty laboratory and office locations in the Netherlands, and an extensive partner laboratory network worldwide, has been part of the Cerba Research group since early 2022. By fully entering into the Cerba Research brand now, the company underscores its collective focus and dedication to the advancement of clinical research together.

The name change of Viroclinics-DDL to Cerba Research marks a natural step forward in the company’s mission to accelerate the development of life-saving therapies and improve patient outcomes; uniquely positioning Cerba Research to offer a broader portfolio of research and clinical trial solutions spanning virology, oncology, cell & gene therapy, and beyond.

The Netherlands business unit combines the strengths and capabilities of existing specialty laboratory services with Cerba Research’s unique global footprint which includes Africa, USA, Europe, Asia Pacific, and Australia to provide end-to-end support throughout the drug development lifecycle across the globe; from pre-clinical research and biomarker discovery to clinical trial management and epidemiological studies.

For more information about Cerba Research and its comprehensive portfolio of research and clinical trial solutions, please visit www.cerbaresearch.com.

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About Cerba Research
We offer world-class clinical research that helps life science companies to successfully develop the predictive and precision medicines of the future.​
We combine the deep expertise and agility of the specialist laboratory with the capacity, breadth and global reach of a central lab. Our unique approach to patient data offers our customers the opportunity to have one partner for all their test services, with regular access and consistent support across all clinical trial phases.​
Our customer-centric approach means flexible solutions to unique challenges, providing reassurance and efficacy, whilst offering agility at scale. Our customers today are our partners tomorrow.

 

Contact

marketing@cerbaresearch.com

 

Keywords: Laboratories;  Vaccines;  Antiviral Agents;  Clinical Trials as Topic;  Research Design;  Clinical Protocols;  Epidemiologic Studies;  Drug Development;  Biomarkers;  Vaccines;  Netherlands; Viroclinics-DDL; Cerba Research; Name change; Specialty laboratory; Research; Clinical trials; Pre-clinical research; Biomarker discovery; Clinical trial management; Drug development; Specialist laboratory; Central lab; Patient data

Published by Biotech Newswire

Single Use Support Opens US Office

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Fluid and cold chain management expert Single Use Support has opened a subsidiary in Lexington, Massachusetts. Equipped with a product showroom, the office will also serve as a base for increased US staff.

KUFSTEIN, Austria, March 14, 2024 / Biotech Newswire / -- Single Use Support, a leading process solution provider specializing in cold chain logistics, announces the opening of its latest branch office in Lexington, Massachusetts. Strategically positioned within proximity to the innovative pharmaceutical hub of Boston, the new office underscores Single Use Support's ambition for further expansion and for improving efficiency and product quality in biopharmaceutical manufacturing.

The Lexington office, spanning 2,320 square feet, showcases Single Use Support's commitment to enhancing customer service and industry collaboration. CEO Christian Praxmarer emphasized the significance of the inauguration, stating, "Our increased presence in the USA reflects our dedication to advancing biopharmaceutical innovation. And with the opening of our showroom and the bolstered staffing in Lexington we will facilitate faster service for our customers."

Elevated Workforce to Strengthen Customer Service

In conjunction with the office opening, Single Use Support has expanded its US-based sales and service team with the addition of order management and automation experts. Both existing and prospective customers will greatly benefit from the increased presence of the pioneering process solutions provider in the US.

Several US-based pharmaceutical manufacturers and CDMOs have recently placed orders for consumables and platform systems for aliquoting, freeze/thaw, storage, and shipping of high-value drug substances. This is in line with Single Use Support’s 70% increase in non-COVID-related revenue by 2023 and a corresponding 40% increase in headcount over the last six months.

Expanded Demo Units in the US

As in Lexington, Single Use Support’s platform and consumable solutions are already on display in Houston, Texas. The process solution provider’s fluid and cold chain management units are part of the mRNA vaccine manufacturing program executed in collaboration with the National Center for Therapeutics Manufacturing and the Texas A&M University, demonstrating the crucial role of the company's fluid and cold chain management solutions in advancing cutting-edge biopharmaceutical technologies.

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Markus Fürniß, Senior Director, Sales USA & Canada (l.), Bernhard Schlichtner, Chief Commercial Officer (m.), Christian Praxmarer, Chief Executive Officer (r.) cutting the ribbon.

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About Single Use Support
Single Use Support is a pioneering process solution provider specializing in fluid and cold chain management of drug substances. Headquartered in Austria, the pioneering company focuses on the development of process solutions to provide manufacturers with 100% safe and efficient handling, liquid transfer, freezing and cold chain shipping of advanced therapies and biologics in pharmaceutical production.

 

Contact

Single Use Support
Michael Eder
Senior Marketing Manager
Endach 36
6330 Kufstein
+43 664 600 43 212
m.eder@susupport.com

 

Keywords: Freezing;  Refrigeration;  Boston;  Biological Products;  Pharmaceutical Preparations;  Austria;  United States; Single Use Support; US Office; Lexington, Massachusetts; Fluid management; Cold chain management; Biopharmaceutical manufacturing; Expansion; Inauguration; Sales and service team; Pharmaceutical manufacturers; CDMOs; Consumables; Platform systems; Aliquoting; Freeze/thaw; Storage; Shipping; mRNA vaccine manufacturing program; National Center for Therapeutics Manufacturing; Cutting-edge biopharmaceutical technologies; Safe handling; Liquid transfer; Advanced therapies

Published by Biotech Newswire

Eisbach and Cancer Focus Fund Announce $4.5 Million Investment to Support First-in-Human Phase 1/2 Trial of EIS-12656 for Refractory Advanced Solid Tumors

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Eisbach Is Enabling the Potential of Synthetic Lethality by Developing Novel Compounds to Exploit Molecular Vulnerabilities Uniquely Present in Many Hard-to-Treat Cancers

MARTINSRIED, Germany and HOUSTON, Texas, March 21, 2024 / Biotech Newswire / -- Eisbach Bio GmbH (Eisbach), a clinical-stage biotechnology company pioneering a new class of cancer medicines leveraging synthetic lethality to target specific proteins that are essential for the survival of cancer cells, and Cancer Focus Fund, LP, a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) to provide funding and clinical expertise to advance promising cancer therapies, today announced that Cancer Focus Fund is investing $4.5 million to support a Phase 1/2 clinical trial of Eisbach’s lead candidate, EIS-12656, which will be conducted at MD Anderson.

EIS-12656 is a small molecule designed to treat tumors that are refractory or resistant to PARP inhibitors. PARP enzymes are involved in critical DNA repair processes. By hindering DNA repair, PARP inhibitors cause tumor cell death, and they have been effective therapies for many ovarian, breast, prostate, and pancreatic cancers. However, their use has been limited by serious toxicities and the development of resistance. EIS-12656 inhibits the chromatin remodeling enzyme ALC1, which is critical to the DNA repair process associated with PARP activation. EIS-12656 was developed by Eisbach to disrupt DNA-damage-dependent PARP activation at an early stage of the repair process. In preclinical studies EIS-12656 overcame PARP inhibitor resistance and demonstrated a benign toxicity profile and blood-brain-barrier penetrance, as well as synergy with PARP inhibitors and other standard-of-care therapies.

“Overcoming the widespread resistance and debilitating side-effects of PARP inhibitors required us to re-think how we tackle the genetic vulnerabilities prevalent in these tumors,” said Dr. Adrian Schomburg, Founder and CEO of Eisbach. “EIS-12656 is a first-in-class small molecule that targets and shuts down the molecular process that reorganizes the tumor genome upon DNA damage and PARP activation – a process that is essential to the survival of cancer cells. Based on its exceptional safety profile and promising activity in preclinical studies, we believe that EIS-12656 has the potential to benefit the many patients with tumors refractory to PARP inhibitors –patients who have few treatment options available today.”

Dr. Andreas Ladurner, Founder and CSO of Eisbach, and Professor and Chair of Physiological Chemistry at Ludwig-Maximilians-University of Munich, commented, “Most cancers contain genome reorganization mechanisms that play critical and very specific roles in tumor biology. By identifying how each of these vital mechanisms is selectively regulated, we can exploit unique molecular vulnerabilities. This approach holds great promise for the discovery of new cancer drugs that are both selective and safe.”

“Eisbach’s distinctive and scientifically sophisticated approach to addressing common difficult-to-treat cancers aligns perfectly with our goals at Cancer Focus Fund,” said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. “We aim to help innovative young companies like Eisbach to rapidly advance unusually promising new cancer drugs into clinical trials with the help of the expert researchers and clinicians at MD Anderson. EIS-12656 has demonstrated the potential to treat many relapsed and refractory tumors more effectively and with fewer side effects than current therapies, and we look forward to following the progress of this exciting first-in-class compound as it proceeds in clinical development. We also are delighted to expand our geographic reach with this first investment in a biotech company based in Germany, with its rich history of biomedical innovation.”

Timothy A. Yap, M.B.B.S., Ph.D., Professor of Investigational Cancer Therapeutics and Vice President and Head of Clinical Development in the Therapeutics Discovery division at MD Anderson, will serve as Principal Investigator of the trial.

 

About the EIS-12656 Phase 1/2 Clinical Trial
The Phase 1/2 open label study will assess the safety, tolerability, and efficacy of EIS-12656 as solo therapy in patients with various solid tumors. The study will involve dose escalation of EIS-12656 monotherapy to establish safety and determine the maximum tolerated dose and recommended Phase 2 dose. In the following stage, dose expansion modules will be conducted with EIS-12656 monotherapy. Additional modules will involve patients progressing under PARP inhibitor treatment.

About EIS-12656, a small molecule inhibitor of ALC1 (CHD1L)
EIS-12656, the lead oncology program at Eisbach, is a first-in-class allosteric small molecule inhibitor targeting the PARP-activated chromatin remodeling helicase ALC1 (also known as CHD1L). The cancer-relevant genome reorganization induced by PARP activation is critically dependent on ALC1 activity. Genetic data have revealed that disruption of this ALC1 activity greatly potentiates PARP inhibitors and produces synthetic lethality in BRCA gene mutations. EIS-12656 was developed by exploiting Eisbach’s ALLOS drug discovery platform that recapitulates the selective, unique, and physiological activation mechanism of its target enzymes in the laboratory. Preclinical data showed that EIS-12656 disrupted cancer cell growth by interfering with the DNA damage and repair (DDR) mechanisms of cancer cells while exhibiting a markedly superior toxicity profile in comparison with currently available therapies targeting DDR pathways. With its first-in-kind, allosteric inhibitory mechanism and superior toxicity profile, EIS-12656 may enable novel monotherapy applications and powerful combination therapies.

About Eisbach
Eisbach is a pioneering, clinical-stage biotech company focused on precision oncology, aiming to disrupt tumor growth by targeting genetic vulnerabilities. The company develops allosteric drugs that selectively disrupt molecular mechanisms, also known as molecular machines, which are vital for tumor genome reorganization. Eisbach combines the genetic vulnerabilities present in defined tumors (synthetic lethality) with its proprietary drug discovery platform, ALLOS, which targets the unique molecular vulnerability of its drug targets, to create first-in-class therapies with fewer side effects. The company’s pipeline includes several small molecule candidates targeting chromatin reorganization that enable potent combination therapies and suppress resistance mechanisms in cancer treatment. For more information, visit www.eisbach.bio and follow us on LinkedIn.

About Cancer Focus Fund
The Cancer Focus Fund LP is a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center (MD Anserson). The fund provides investment support to advance promising cancer therapies that are close to being tested in humans or are in early clinical development, as well as the clinical trial expertise and infrastructure of MD Anderson and strategic partners Ochsner Health System Precision Cancer Therapies Program New Orleans and the LSU Feist Weiller Cancer Center Shreveport. The Fund's objective is to leverage this unique combination to provide investors with superior risk-adjusted returns. In collaboration with partner MD Anderson, the Cancer Focus Fund provides both capital and translational research expertise with the goal of accelerating the development of novel cancer therapies that result in better outcomes for patients while generating returns for investors.

 

Disclosures
The University of Texas MD Anderson Cancer Center’s relationship with Cancer Focus Fund, and all research conducted at MD Anderson related to Cancer Focus Fund, has been identified as an institutional financial conflict of interest by MD Anderson’s Institutional Conflict of Interest Committee and therefore is managed under an Institutional Conflict of Interest Management and Monitoring Plan.

Forward-Looking Statement
This press release contains forward-looking statements that involve risks and uncertainties, including those related to the clinical development of EIS-12656 and other potential therapies. Actual results may differ materially from those projected in these forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the progress of clinical trials, regulatory approvals, market demand for new therapies, and competitive dynamics in the biotechnology sector.

 

Contacts

Eisbach Bio GmbH
Corporate:
Adrian Schomburg, CEO
mediarelations@eisbach.bio

Media:
Jonathan Iorio
+49 89 2153 79013
info@eisbach.bio

Cancer Focus Fund
Corporate:
Ross Barrett
Managing Partner
ross@cancerfocusfund.com

Media:
Barbara Lindheim
BLL Partners for Cancer Focus Fund
blindheim@bllbiopartners.com
+1 917 355-9234

 

Keywords: Capital Financing; Investment; Drug Discovery; Drug Development; Clinical Trial, Phase I; Cell Death;  Neoplasms;  Poly(ADP-ribose) Polymerase Inhibitors;  Blood-Brain Barrier;  Chromatin Assembly and Disassembly;  Synthetic Lethal Mutations;  DNA Repair;  DNA Damage;  Pancreatic Neoplasms;  Biotechnology; Eisbach; Cancer Focus Fund; Phase 1/2 trial; EIS-12656; Refractory advanced solid tumors; Synthetic lethality; PARP inhibitors; DNA repair; Chromatin remodeling enzyme ALC1; Blood-brain-barrier penetrance; Clinical-stage biotechnology company; Clinical trials; Tumor genome reorganization; Genetic vulnerabilities; Precision oncology; Allosteric small molecule inhibitor; CHD1L; BRCA gene mutations; ALLOS drug discovery platform; DNA damage and repair mechanisms; Tumor growth suppression; Chromatin reorganization; Cancer treatment; Drug targets; Germany

Published by Biotech Newswire

Vetter Earns Prestigious Honors Across All Core Categories in the 13th Annual CDMO Leadership Awards

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Trusted Industry Recognition Reinforces Vetter's Commitment to Excellence

  • Recognized as a leading partner for all kinds of pharma and biotech enterprises
  • Award reaffirms mission to provide the highest possible quality and value for customers and their patients
  • 2023 sales result showcases the company's continuous sustainable growth

RAVENSBURG, Germany, March 26, 2024 / Biotech Newswire / -- Vetter once again earned the 2024 CDMO Leadership Awards in all six core categories – quality, expertise, reliability, capabilities, compatibility and service for big pharma, small pharma and overall respondents. The award reaffirms Vetter’s mission to provide the highest possible quality and value for pharma and biotech companies worldwide in their development, manufacturing as well as assembly and packaging of injectables.

“We are dedicated to embodying the characteristics that this award highlights to provide the best to our customers and their patients. We leverage our decades of experience and the expertise of our 6,300 employees to do so,” shared Vetter’s Managing Director Peter Soelkner. “To be recognized once again by the CDMO Leadership Awards is a testament that we are living out our company mission in the work we do every day.”

In fact, with a result of € 1,002 million in completed orders over the past financial year, Vetter has successfully reached to surpass the one billion sales threshold. This confirms the strong commitment to stable customer relationships and ongoing sustainable growth.

The awards program provides a unique representation of the level of excellence offered to customers, as honorees are selected based on customer evaluations of the CDMOs they have worked with over the past 18 months. Now in its 13th year, Outsourced Pharma and Life Science Leader's CDMO Leadership Awards provide its audiences with accurate and dependable customer feedback to help them select a reputable partner for their development, manufacturing and packaging needs.

“As drug owners are increasingly counting on CDMOs to provide unwavering access to supply chains, appropriate infrastructure, and proven processes, the CDMO Leadership Awards reflect our commitment to act as their outsourcing partner of choice,” said Vetter Managing Director Thomas Otto. “We are proud that this further instills a sense of confidence in our trustworthiness among our current and future customers.”

Louis Garguilo, Chief Editor and Conference Chair of Outsourced Pharma added: “Drug and therapy sponsors had much to be concerned with during the last 12 months or so. There was still supply-chain uncertainty, ever-growing novelty in platforms and processes requiring new skill sets and technologies, and the speed of everything seemed to accelerate. Through it all, CDMOs stayed focused and also adapted to customer and market needs. Those best at serving their customers and thus patients are recognized as the 2024 CDMO Leadership Award winners.”

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© Vetter Pharma International: The Vetter team including Managing Director Peter Soelkner (2nd from left) is proud to accept the CDMO Leadership Awards 2024 on behalf of the company.

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Find the Vetter press kit and more background information here.

 

About Vetter
Vetter is a leading Contract Development and Manufacturing Organization (CDMO) with headquarters in Ravensburg, Germany, and production facilities in Germany, Austria, and the US. As a global player, the pharmaceutical service provider is also present with its own sales locations in the Asia-Pacific markets of Japan, China, South Korea and Singapore. Around the world, small and large renowned pharma and biotech companies rely on the decades of experience, high quality, modern technologies, reliability, and commitment of more than 6,300 employees. In close partnership with its customers, the Vetter team supplies patients all over the world with medicines, many of which are vital. The CDMO provides support from drug product development through clinical and commercial filling to a wide range of assembly and packaging services for vials, syringes, and cartridges. With innovative solutions, Vetter develops prefilled drug-delivery systems together with its customers to continuously improve patient safety, comfort, and compliance. The company is an industry pioneer in sustainability and a socially and ethically responsible corporate citizen. The CDMO is a member of the UN Global Compact and Science Based Target initiative (SBTi) and received platinum status in the renowned EcoVadis ranking. Multiple awards such as the CDMO Leadership Awards, Frost & Sullivan Customer Value Leadership award or the recognition as Best Managed Company emphasize Vetter’s commitment to sustainable business. Founded in Ravensburg in 1950, the company remains family-owned to this day. For more information, visit www.vetter-pharma.com and follow Vetter on LinkedIn.

 

Contact

Vetter Pharma International GmbH
Markus Kirchner
Corporate Spokesperson / Media Relations
Eywiesenstrasse 5
88212 Ravensburg
Germany
+49 (0)751-3700-3729
PRnews@vetter-pharma.com

 

Keywords: Awards and Prizes; Drug Development; Clinical Trials as Topic; Pharmaceutical Services; Biotechnology; Pharmaceutical Preparations; Laboratories; Drug Packaging; Product Packaging; Drug Delivery Systems; Syringes; Outsourced Services; Commerce; Biological Products; Germany; Vetter; CDMO Leadership Awards; Pharma; Biotech; Outsourcing partner; Processes; Drug sponsors; Supply-chain uncertainty; Pharmaceutical service provider; Technologies; Patient safety; Prefilled drug-delivery systems; Sustainability; Corporate responsibility; UN Global Compact; EcoVadis ranking; Awards; Family-owned company

Published by Biotech Newswire

ProteoNic Unveils Early Access Program, Elevating Viral Vector Titers with Transformative LV-2G UNic® Technology

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LEIDEN, the Netherlands, March 27, 2024 / Biotech Newswire / -- ProteoNic Biosciences, a leading provider of premium vector technology and services for the production of biologics, is announcing the launch of its highly anticipated LV-2G UNic® Early Access Program. This program marks a significant milestone in lentivirus manufacturing optimization, offering access to groundbreaking vector technology designed to revolutionize viral vector production.

With the official launch on March 20, 2024, ProteoNic extends a warm invitation to CDMOs, biotechs, and biopharmaceutical companies to experience firsthand the transformative potential of LV-2G UNic®. By seamlessly integrating this cutting-edge vector technology into existing systems, participants can achieve remarkable enhancements in titers, paving the way for increased viral vector production capacity and substantial improvements in manufacturing cost efficiency.

Frank Pieper, CEO of ProteoNic, shared his excitement about the program's potential impact, stating, "The LV-2G UNic® Early Access Program will serve as a launching platform for our viral vector manufacturing innovation. By offering early access to our state-of-the-art vector technology, we empower researchers to unlock unprecedented levels of efficiency and productivity in viral vector manufacturing."

LV-2G UNic® represents next generation vector technology, engineered to elevate lentiviral titers across a wide array of expression systems. The technology drives enhanced infectious viral particle production, by providing a significant boost in gRNA production through increased transcription levels achieved with ProteoNic’s patented Dual Promoter system.

Participation in the LV-2G UNic® Early Access Program offers exclusive benefits, including access to ProteoNic’s cutting-edge LV-2G UNic® vector technology, optimizing lentiviral particle expression and co-development opportunities. This technology can be seamlessly integrated into current workflows with minimal to no process development required.

For more information about LV-2G UNic® and the Early Access Program, visit proteonic.nl

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About ProteoNic BV
ProteoNic is a privately held company with offices in Leiden, the Netherlands and in the Boston area, USA. The company offers technology and services for the generation of cell lines and viral vectors with greatly improved production characteristics. The company commercializes its proprietary 2G UNic® technology through licensing and partnership arrangements.

 

Contact

ProteoNic BV
Jonathan Frampton, PhD
Director, Business Development
+44 7961 144115
frampton@proteonic.nl

 

Keywords: Manufacturing Industry; Genetic Vectors; Genetic Therapy; Cell- and Tissue-Based Therapy; Regenerative Medicine; Biological Products; Industry; Biotechnology; Technology; Lentivirus; Genetic Therapy; Cell Line Development; Cell Proliferation; Cells, Cultured; Netherlands; ProteoNic Biosciences; Vector technology; Biologics; LV-2G UNic®; Early Access Program; Lentivirus manufacturing; CDMOs; Biotechs; Biopharmaceutical companies; Titer enhancement; Viral vector production; Manufacturing cost efficiency; Frank Pieper; Infectious viral particle production; gRNA production; Dual Promoter system; Cell lines; Leiden, Netherlands; Boston, USA; Licensing; Partnership arrangements

Published by Biotech Newswire

ProBioGen and DIOSynVax Partner to Manufacture Groundbreaking Multivalent Vaccine for Hemorrhagic Fever

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BERLIN, Germany, March 27, 2024 / Biotech Newswire / --
ProBioGen, a globally recognized and experienced Contract Development & Manufacturing Organization (CDMO), proudly announces a partnership with DIOSynVax Ltd to manufacture DIOS-HFVac3, a trivalent hemorrhagic fever (HF) vaccine that was developed in collaboration with Prof. Wagners team (Molecular Virology, Institute of Medical Microbiology and Hygiene, University of Regensburg). The novel vaccine targets HF diseases caused by Ebola, Marburg, and Lassa viruses. Epidemics of viral hemorrhagic fevers are a major public health concern and a major economic burden. Especially the increase of simultaneous epidemics in low and middle-income African regions stresses the urgency of a multivalent vaccine produced on a production platform resilient against supply limitations. The pre-clinical efficacy of the novel trivalent vaccine has been demonstrated in challenge studies in animal models. ProBioGen’s MVA CR19 vector will be used to deliver the three HF vaccine antigens.

DIOS-HFVac3 will be manufactured on ProBioGen's cutting-edge industrial platform, which was developed for the production of a broad range of viral vaccines. The platform consists of the company’s proprietary AGE1.CR.pIX suspension cell line, proprietary chemically defined media and advanced scalable production and purification process. Under the terms of the agreement, ProBioGen will conduct process and analytical development followed by manufacturing of DIOS-HFVac3 for clinical trials and subsequent regulatory approval.

"Our collaboration with DIOSynVax represents a significant milestone in ProBioGen's journey," said Dr. Volker Sandig, Chief Scientific Officer at ProBioGen. "Our innovative platform for the manufacturing of DIOS-HFVac3 underscores our commitment to advancing robust and resilient biopharmaceutical solutions for global health challenges, independent of the geographic region where these challenges may occur."

"This project marks the company's dedication to pioneering technologies and expanding its service value chain. "We are thrilled to embark on this transformative journey with DIOSynVax," stated Dr. Lutz Hilbrich, CEO of ProBioGen. "This partnership exemplifies our unwavering commitment to driving advancements in biopharmaceutical manufacturing and delivering life-saving therapies to those in need."

DIOSynVax's CEO Prof. Jonathan Heeney expressed confidence in the collaboration, emphasizing ProBioGen's role as a trusted partner. "We are delighted to continue our fruitful partnership with ProBioGen," stated DIOSynVax's CEO. "Their expertise, dedication, and collaborative spirit have been instrumental in our joint efforts. Together, we are poised to make a significant impact by bringing this vital vaccine to developing countries, mainly in Africa."

This research is funded by the Department of Health and Social Care as part of the UK Vaccine Network (UKVN), a UK Aid program to develop vaccines for diseases with epidemic potential in low and middle-income countries (LMICs).

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About AGE1.CR.pIX®: Avian Cell Line Platform for Industrial Viral Vaccine Manufacturing
The AGE1.CR.pIX cell line is derived from primary cells of a duck embryo and is designed to comply with health authority guidelines. It was developed as an alternative to the use of chicken eggs for large-scale vaccine production. The AGE1.CR.pIX cell line grows in true suspension and has been optimized for viral vaccine production and stability. It grows in a commercially available, chemically defined medium without animal components and is an excellent host for a variety of different virus strains, including different strains of attenuated poxviruses such as fowlpox virus, MVA and MVA CR19.

About MVA-CR19
MVA is a proven and save vector and the production of MVA in AGE1.CR.pIX® cell lines has significant advantages compared to the CEF platform. For example, the total yield of infectious units and the concentrations achieved where higher in preparations obtained with AGE1.CR.pIX® and cost of goods were lower.
Yet improved yields for reliable supply and reduced costs can be achieved with advanced MVAs adapted to modern production processes. One such vector is a novel strain of MVA that has been derived and fully sequenced by ProBioGen. ProBioGen and others could show that the MVA strain CR19 consistently replicate to very high titers (in the range of 10^9 IU/mL or above) in conventional stirred tank bioreactor processes, with or without intensivation by (for example) ATF. The CR19 strain is the well-known attenuated MVA that does not contain any ectopic or novel genes and does not replicate in human cells. Compared to conventional/ wild-type MVA, changes in MVA-CR19 can be summarized as loss of non-structural genes, increased gene doses for selected supportive genes, and longer inverted terminal repeats which may improve the function of the viral telomers.
Genomic stability of parental and recombinant MVA-CR19, parental wildtype and recombinant wildtype MVA, and novel vaccinia constructs have been demonstrated by serial passaging of multiple vector constructs in the AGE1.CR.pIX® production system. Stability of the karyotype and genetic markers of the AGE1.CR.pIX® cell line have also been demonstrated.

About DIOS-HFVac3
The DIOS-HFVac3 candidate vaccine delivers RNA- and codon optimized sequences encoding engineered antigens for increased breadth of protection derived from 3 different viruses - Ebola- and Marburg, and Lassa Fever viruses - via a poxviral vector, shown to protect from mpox infection and/or disease.
This vaccine candidate has shown impressive results in preclinical trials, demonstrating a robust immune response protecting relevant animal models from challenge with Ebola-Sudan, Marburg, or Lassa virus induced disease, making it a promising candidate in the fight against these important epidemic disease threats.

About the UK Vaccine Network
The Department for Health and Social Care (DHSC) is the UK Government department which is responsible for helping people to live more independent, healthier lives for longer. This investment is part of the UK Vaccine Network (UKVN). UKVN was established to provide funding to support the development of promising vaccines and vaccine technologies that will help combat infectious diseases that have epidemic potential in low and middle-income countries (LMICs). UKVN is an UK Aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs).

About DIOSynVax
DIOSynVax is a clinical-stage biotech company specialising in the digital (computational) design and development of innovative vaccine antigens for expanded breadth of protection from variable viruses. Founded in 2017 as a spin-out from the University of Cambridge, DIOSynVax employs a multi-disciplinary team of experts in fields such as computational and structural biology, vaccinology, virology, immunology with clinical trial and regulatory expertise. This multidisciplinary approach allows DIOSynVax to address unmet needs and gaps in human vaccines, enhancing efficacy and broadening the scope of human health afforded by improved vaccines.
DIOSynVax's vaccine candidates are meticulously digitally engineered and designed antigens combined as vaccine antigen payloads, with safety and efficacy being paramount considerations in pre-clinical testing. Advanced machine learning (AI) strategies further enhance the company's capabilities, aiding in viral sequence analysis and vaccine candidate generation.
DIOSynVax operates from its base at the University of Cambridge’s innovation-focused West Cambridge site, providing the company with access to top-tier talent and state-of-the-art facilities. For processes beyond its in-house capabilities, the company confidently engages with trusted CROs, ensuring timely and cost-effective delivery of its innovative solutions.

About ProBioGen (Business / Corporate)
ProBioGen is a premiere, Berlin-based specialist for developing and manufacturing biopharmaceutical active ingredients, viral vectors and vaccines with applying proprietary technologies to improve product quality and features. Combining both state-of-the-art development services, together with intelligent product-specific technologies yields biologics with optimized properties. Rapid and integrated cell line and process development, comprehensive analytical development and GMP-compliant manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).
ProBioGen has been operational for almost 30 years. At four locations in Berlin, 300 employees contribute to the creation of new therapies in medicine and groundbreaking innovations worldwide through their creative and meticulous work. ProBioGen's growth strategy is driven by the expansion of the service value chain through organic growth and potential acquisition. Diversification is a complement driver, while the focus is strict on enabling the development of biopharmaceuticals for tomorrow.
For more information about ProBioGen, follow us on LinkedIn.

 

Contacts

ProBioGen
Dr. Gabriele Schneider
Chief Business Officer
cdmo@probiogen.de

ProBioGen Press Contact
Jana Windt
Head of Marketing and Communications
press@probiogen.de

DIOSynVax
Rebecca Kinsley
Chief Operating Officer
rebecca.kinsley@diosvax.com

 

Keywords: International Cooperation; Hemorrhagic Fevers, Viral; Lassa virus; Ebolavirus; Marburgvirus; Vaccines; Viruses; Marburg Virus Disease; Cell Line; Technology; Cell Culture Techniques; Culture Media; Cell Proliferation; Cell Line Development; Cells, Cultured; Ducks; Viruses; Vaccines; Viral Vaccines; Virus Cultivation; Biological Products; Productivity; Technology; Bioreactors; Commerce; Germany; ProBioGen; DIOSynVax; Partnership; Multivalent vaccine; Vaccine development; Trivalent vaccine; Ebola; Marburg; Lassa virus; Epidemics; Vaccine manufacturing; Viral vector; Production platform; Process development; Clinical trials; Regulatory approval; MVA CR19 vector; Viral vaccine production; AGE1.CR.pIX suspension cell line; Chemically defined media; Global health challenges; Biologics

Published by Biotech Newswire


Touchlight Awarded Tender to Supply Enzymatic dbDNA to CPI’s RNA Centre of Excellence

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HAMPTON, UK, March 28, 2024 / Biotech Newswire / -- Touchlight, an innovation-driven CDMO enabling the development of genetic medicines with its doggybone DNA (dbDNA™) technology and leaders in enzymatic DNA production, is delighted to announce that it has been awarded a tender to deliver enzymatic DNA as part of CPI’s tender process for the establishment of its RNA Centre of Excellence.

CPI, a leading technology innovation centre in the UK, has selected Touchlight to supply research and GMP-grade enzymatic DNA for the development and manufacture of RNA therapeutics and vaccines. With Touchlight’s dbDNA platform already used in two clinical studies as a critical starting material for mRNA production, Touchlight will contribute its expertise and cutting-edge technology to facilitate the development and scale-up of novel RNA therapeutics.

The selection of Touchlight as a supplier for enzymatic DNA underscores the company’s reputation for delivering high-quality DNA across applications in the genetic medicines industry, including in viral vector production, mRNA, genome editing and DNA vaccines. Touchlight’s dbDNA offers unparalleled advantages in terms of scalability, quality, and safety, making it an ideal choice to enable CPI’s RNA Centre of Excellence.

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Karen Fallen, CEO of Touchlight said “We’re excited to support CPI and its partners in the development and manufacture of mRNA products. CPI’s RNA Centre of Excellence promises to be a crucial part of the mRNA supply chain in the UK, helping to advance mRNA vaccines and therapies more quickly.”

Julie Anderson, Head of RNA Centre of Excellence at CPI said: "It is important for CPI to include access to the high-quality DNA templates produced by Touchlight for our clients for the development and manufacture of RNA therapeutics.  We are impressed by the capabilities of the Touchlight team and are looking forward to including their synthetic templates in the development of our partners' RNA medicines."

 

About Touchlight
Touchlight is a privately-owned innovation-driven CDMO based in London, U.K., focused on the provision of DNA services and manufacture of enzymatically produced doggybone DNA (dbDNA™) to enable the development of genetic medicines. Touchlight provides rapid, enzymatic DNA development and manufacturing for all advanced therapy production, including mRNA, viral and non-viral gene therapy and DNA API. dbDNA is a minimal, linear, covalently closed structure, which eliminates bacterial sequences. Touchlight’s revolutionary enzymatic production platform enables unprecedented speed, scale, and the ability to target genes with a size and complexity that is impossible with current technologies. Clients can be supported from pre-clinical through clinical development, to licencing and tech transfer for use in-house. 

About CPI
We're a pioneering social enterprise that accelerates the development, scale-up and commercialisation of smart AgriFoodTech, energy storage, HealthTech, materials, and pharma innovations. Through our incredible innovation experts and infrastructure, we look beyond the obvious to transform healthcare and drive towards a sustainable future.
Developing next-generation medicine manufacturing innovations to deliver tomorrow's vaccines and therapeutics. We offer world-leading facilities and expertise in small molecules, biologics, oligonucleotides, and complex medicines to accelerate drug development and scale-up. We host the largest pool of RNA biomanufacturing experts in the UK and offer complementary drug delivery systems like lipid nanoparticles.
We're creating agile, efficient, and sustainable supply chains by convening actors across the pharma industry ecosystem in a pre-competitive space and boosting the adoption of industry 4.0 advanced processes and digitisation.
We're a pioneering social enterprise that accelerates the development, scale-up and commercialisation of smart AgriFoodTech, energy storage, HealthTech, materials, and pharma innovations. Through our incredible innovation experts and infrastructure, we look beyond the obvious to transform healthcare and drive towards a sustainable future.
As a trusted partner of industry, academia, government, entrepreneurs, and the investment community, we connect the dots within the innovation ecosystem to make great ideas and inventions a reality. We believe by working together we can build a better collective future, and as part of the High Value Manufacturing Catapult, we facilitate access to world-class organisations to deliver transformation across industries and landscapes. Creating lasting global impact from the North of England and Scotland, we invest in people and disruptive technologies to invigorate economies, create circular supply chains and make our world a better place.

 

Contact

Touchlight
Karen Fallen, Chief Executive Officer
info@touchlight.com
+44 20 8481 9200

 

Keywords: Manufacturing Industry; Vaccines, DNA; RNA, Messenger; Gene Editing; DNA; RNA; Technology; United Kingdom; Touchlight; Enzymatic dbDNA; CPI; RNA Centre of Excellence; Genetic medicines; mRNA; Vaccines; Genetic medicine industry; Clinical studies; Viral vector production; Genome editing; DNA vaccines; Karen Fallen; Julie Anderson; London, U.K.; CDMO (Contract Development and Manufacturing Organization); Doggybone DNA (dbDNA™); GMP-grade DNA; mRNA products; Genetic medicine manufacturing; High-quality DNA; RNA therapeutics; Oligonucleotides; Drug delivery systems; Circular supply chains

Published by Biotech Newswire

First Study Using Biomimetic AI Digital Twins And Multiomics in Genetics Research

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Paper on the groundbreaking research by Genzeva, LumaGene, RYLTI, Brigham & Women’s Hospital of Harvard University, and QIAGEN Digital Insights was published this week in the Journal of Molecular Diagnostics (https://www.jmdjournal.org/article/S1525-1578(24)00062-X/fulltext)

ROCKVILLE, MD, April 03, 2024 / Biotech Newswire / -- Revolutionary genomic research by Genzeva, LumaGene, RYLTI, Brigham & Women’s Hospital of Harvard University, and QIAGEN Digital Insights  applied an innovative use of multiomics and biomimetic digital twins to unveil new DNA variants associated with the development of endometrial related disorders. This study marks a significant leap forward in understanding the molecular mechanisms of endometrial-related disorders.

In a paper published this week in the Journal of Molecular Diagnostics, the study led by geneticist Dr. William G. Kearns, Co-founder, CEO and Chief Scientific Officer of Genzeva and LumaGene, employed cutting-edge methodologies incorporating clinical exome sequencing, phenotype-driven variant analysis, and RYLTI's Knowledge Engineering (RKE) Biomimetic AI Platform and Digital Twin Ecosystem, to analyze patient samples with endometriosis. This unprecedented multidimensional approach uncovered novel insights by analyzing hidden “dark” data, which allowed the team to identify eight pathogenic mutations and four variants of unknown clinical significance (VUSs) relevant to this disorder.

In addition to identifying pathogenic DNA variants the research also identified four VUSs potentially associated with the development of endometrial-related disorders. One VUS identified in the MUC20 gene was present across all patient samples and could be a potential biomarker for diagnostics. The other identified VUSs in genes USP17L1, FAM66B, and DEFB109B all mapped to the short arm of chromosome 8. The expression of the DEFB109B and FAM66B genes are regulated by the same gene enhancer.

The paper, “The Application of Knowledge Engineering via the use of a Biomimetic Digital Twin Ecosystem, Phenotype Driven Variant Analysis, and Exome Sequencing to Understand the Molecular Mechanisms of Disease,” was authored by Kearns and collaborators Dr. J. Georgios Stamoulis (QIAGEN Digital Insights), Joseph Glick and Lawrence Baisch (RYLTI BioPharma); Andrew Benner, Dalton Brough, Dr. Luke Du (Genzeva); Dr. Bradford Wilson (IndyGeneUS AI); Laura Kearns (Genzeva and LumaGene); Nicholas Ng, Maya Seshan, and Dr. Raymond Anchan (Brigham and Women’s Hospital, Harvard University).

“This landmark study demonstrated a way to combine omics and a digital twin ecosystem to understand the molecular mechanism of disease better. By incorporating Genzeva’s multiomics platform, QIAGEN’s Digital Insight, and RYLTI’s pioneering biomimetic AI platform for genomic analyses we uncovered hidden dark data with insights that may never have been achievable before. The possibility to redefine this scientific approach promises a new horizon in many fields of research, and the biotech industry eagerly anticipates the impact of these innovative techniques on future discoveries and therapeutic interventions,” commented Dr. Kearns.

In January, Life Sciences Review Magazine  awarded RYLTI Top Biomimetic AI Platform of 2024 for its biomimetic AI digital twin ecosystem innovation, hailing the technology for opening new doors to discovery and accelerating the innovation process.

Dr. Ray Anchan, Asst. Professor Harvard Medical School/Co-Director, Brigham, and Women’s Hospital Center for Endometriosis, said: "The computational capacity of knowledge engineering using a biomimetic digital twin ecosystem provides a unique opportunity to efficiently identify novel and unique DNA variants in various disease processes that could prove useful for developing new targeted therapies.”

"The NAS has described the importance of using digital twins in biomedical research, which requires a toolset without limitations or bias for effective discovery and validation," said Joseph Glick, an award-winning biomimetic AI pioneer and Co-founder/Chief Innovation Officer of RYLTI. “This new innovative omics method incorporating phenotype ranking algorithms with digital twins demonstrates the potential to enhance the drug discovery process with the inclusion of data, enabling improved decision making, expedited development timelines, refined target identification, and reduced risks.”

“This exciting breakthrough with use of the first biomimetic digital twins comes at a very exciting time for us, not only in advanced genomic research, but across biopharma and in other sectors,” said Peter Fiorillo, Co-founder and CEO of RYLTI.

 

About GENZEVA
GENZEVA is a leading molecular diagnostic laboratory utilizing advanced multiomicsand patent-pending technology solutions. It provides services to healthcare research organizations worldwide, clinicians, and referring laboratories.

About RYLTI BioPharma
RYLTI is the architect behind its revolutionary RYAILITI Knowledge Engineering (RKE) Biomimetic AI Digital Twin Platform and innovative solutions for a variety of industries, including the pharmaceutical, biotechnology, renewable energy, telecommunications, financial services, and technology industries, among other sectors. 

 

Contacts

Peter Fiorillo
CEO RYLTI BioPharma Inc
pfiorillo@rylti.com
+1.631.806.2108

Dr. William G. Kearns
CEO and CSO Genzeva and LumaGene
wgkearns@genzeva.com
+1.301.366.1666

 

Keywords: Female; Endometriosis; Biomimetics; Chromosomes, Human, Pair 8; Exome Sequencing; Multiomics; Phenotype; Biomarkers; Hospitals; DNA; Pathology, Molecular; United States; Genzeva; LumaGene; RYLTI; Brigham & Women’s Hospital of Harvard University; QIAGEN Digital Insights; Biomimetic AI; Digital twins; Genetics research; Journal of Molecular Diagnostics; Endometrial-related disorders; DNA variants; Clinical exome sequencing; Phenotype-driven variant analysis; Knowledge Engineering (RKE) Biomimetic AI Platform; Patient samples; Pathogenic mutations; Variants of unknown clinical significance (VUSs); MUC20 gene; USP17L1 gene; FAM66B gene; DEFB109B gene; J. Georgios Stamoulis; Joseph Glick; Lawrence Baisch; Andrew Benner; Dalton Brough; Luke Du; Bradford Wilson; Laura Kearns; Nicholas Ng; Maya Seshan; Raymond Anchan; Biomimetic AI Platform; Computational capacity; Therapeutic interventions; Endometriosis; Harvard Medical School; NAS (National Academy of Sciences); Drug discovery process; Phenotype ranking algorithms; Peter Fiorillo; Molecular diagnostic laboratory; Patent-pending technology solutions; Healthcare research organizations; RYAILITI Knowledge Engineering (RKE) Biomimetic AI Digital Twin Platform

Published by Biotech Newswire

University of Liverpool to Use Touchlight’s Rapid Enzymatic dbDNA in Fully Personalised Neoantigen Cancer Vaccine Clinical Study

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The UK’s Medical Research Council is funding a 10-patient Phase I study to deliver rapid personalised treatment for lung cancer patients.

HAMPTON, UK, April 03, 2024 / Biotech Newswire / -- Touchlight, a CDMO enabling the development of genetic medicines with its enzymatic doggybone DNA (dbDNA™) technology, today announced an agreement with University of Liverpool for the use of dbDNA in the development of a fully-personalised therapeutic neoantigen DNA vaccine for patients with non-small cell lung cancer, to be given to patients at Clatterbridge Cancer Center, Liverpool.

Non-small cell lung cancer is the most common type of lung cancer, with almost 50,000 new diagnoses each year. It is the third most prevalent cancer in the UK and, globally, it is estimated that there were 2.2million new cases in 2020 alone.

The University of Liverpool researchers will be conducting a clinical trial that involves making a personalised cancer vaccine for each patient. The approach is designed to train the patient’s own immune system by targeting mutations in patients’ individual cancer and support patients who have not had sufficient benefit from standard immunotherapy.

Touchlight’s dbDNA technology produces a minimal, linear, double stranded, covalently closed DNA vector through an enzymatic manufacturing process.

dbDNA technology can deliver high purity GMP DNA in a small footprint at unprecedented speed and is ideally positioned to enable rapid individual personalised vaccines to cancer patients.

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Prof. Christian Ottensmeier, Chief investigator and shared lead of the project of the study said: "We are delighted to work with Touchlight on developing this trial. The dbDNA approach offers a way to make vaccines very quickly, including for personalised treatments. We are very excited that we will be able to offer this clinical trial to patients with advanced lung cancer in Liverpool and expect that patients can be included starting in the 2nd half of 2024."

Prof. Natalia Savelyeva, joint lead of the study added: "This trials results from a long-standing collaboration between our team and Touchlight. The vaccine platform is completely novel and we believe has enormous promise in providing cancer vaccines that need to be made for each individual patient”.

Karen Fallen, CEO, Touchlight commented: “We are delighted to be able to support the Liverpool team in the development of such an innovative therapeutic approach. Christian and his team are world-leaders in cancer immunology, and we are proud that our dbDNA technology is able to provide an improved turnaround time for a patient group with extremely high unmet need.

 

About Touchlight
Touchlight is a privately-owned innovation-driven CDMO based in London, U.K., focused on the provision of DNA services and manufacture of enzymatically produced doggybone DNA (dbDNA™) to enable the development of genetic medicines. Touchlight provides rapid, enzymatic DNA development and manufacturing for all advanced therapy production, including mRNA, viral and non-viral gene therapy and DNA API. dbDNA is a minimal, linear, covalently closed structure, which eliminates bacterial sequences. Touchlight’s revolutionary enzymatic production platform enables unprecedented speed, scale, and the ability to target genes with a size and complexity that is impossible with current technologies. Clients can be supported from pre-clinical through development and supply, to licencing and tech transfer for use in-house.

 

Contact

Touchlight
Karen Fallen, Chief Executive Officer
info@touchlight.com
+44 20 8481 9200

 

Keywords: Manufacturing Industry; Vaccines, DNA; RNA, Messenger; Gene Editing; DNA; RNA; Technology; United Kingdom; University of Liverpool; Touchlight; Enzymatic dbDNA; Personalized neoantigen cancer vaccine; Clinical study; Phase I study; Lung cancer; Clatterbridge Cancer Center; Non-small cell lung cancer; Immunotherapy; GMP DNA; Prof. Christian Ottensmeier; Prof. Natalia Savelyeva; Cancer immunology; Genetic medicines; CDMO (Contract Development and Manufacturing Organization); Doggybone DNA (dbDNA™); Enzymatic manufacturing process; Minimal DNA; Linear DNA; Rapid individual personalized vaccines; High purity DNA; mRNA; Viral and non-viral gene therapy; DNA API; Bacterial sequences; Enzymatic production platform; Licensing; Tech transfer; Genetic medicine development

Published by Biotech Newswire

Celonic Launches New GS-CHOvolution® Cell Line Expression System

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GS-CHOvolution® is based on Revvity’s CHOSOURCE™ expression platform and TnT transposon technology

BASEL, Switzerland April 08, 2024 / Biotech Newswire / -- Celonic has signed a commercial license agreement with Revvity for its CHOSOURCE™ expression platform and TnT transposon technology. The Revvity expression platform will be used in combination with Celonic’s expertise and workflows to enhance the cell line development of monoclonal antibodies (mAbs) and complex proteins.  

GS-CHOvolution® is based on Revvity’s gene-edited Glutamine Synthetase (“GS”) knockout Chinese Hamster Ovary (CHO-K1) cGMP-compliant cell line and the TnT transposon technology to accelerate cell line development timelines and to streamline the selection of high expressing clones during cell line development. GS-CHOvolution’s expression platform is a well-established industry standard for biomanufacturing due to its ability to produce high yields of quality therapeutic proteins and is recognized by regulators as suitable for the manufacturing of monoclonal antibodies (mAbs) and complex proteins.

Biotech and pharma companies can use GS-CHOvolution’s® expression system through a simplified license fee model without royalties.

Dr. Samanta Cimitan, CEO Celonic Group, commented: “We are delighted to partner with Revvity to provide our customers a state-of-the-art GS expression platform with a track record of success which complements Celonic’s early phase offering. We are committed to bringing our customers of all sizes, expertise, agility and solutions to develop and manufacture life-improving drugs effectively and efficiently.”

Dr. Alan Fletcher, Revvity’s senior vice president, life sciences, stated: “Celonic and Revvity are likeminded organizations, we both seek to enable our customers and help advance the biotherapeutics of tomorrow. We are very pleased that Celonic has chosen the CHOSOURCE expression platform for their contract development and manufacturing services. Our well-established cGMP manufacturing CHO cell line has over 65 INDs filed globally and empowers companies to accelerate and streamline biotherapeutic development programs from DNA to clinical manufacturing. But what truly differentiates Revvity is our commitment to the evolution of our platforms and ongoing collaboration with our partners to achieve their current, as well as future, development and manufacturing needs.”

 

About Celonic
Celonic is a “Pure Play” Biologics Contract Development Manufacturing Organization (CDMO) with significant expertise in the development and manufacturing of CHO based monoclonal antibodies and other molecules. Celonic’s roots trace back to 1982 as a spin-off of the Max Planck Institute in Germany. Today Celonic has a state-of-the-art Biologics Development and Innovation Center in Basel, Switzerland (headquarters), and clinical and commercial GMP manufacturing facilities in Heidelberg, Germany. At present, more than 500 highly qualified employees work at Celonic.
Follow @CelonicGroup on LinkedIn.

About Revvity
At Revvity, “impossible” is inspiration, and “can’t be done” is a call to action. Revvity provides health science solutions, technologies, expertise and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more.
With 2023 revenue of more than $2.7 billion and over 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 190 countries.
Stay updated by following our NewsroomLinkedInXYouTubeFacebook and Instagram.

 

Contact

Celonic Group
Elisa Witt
Elisa.Witt@celonic.com
+41 76 588 67 59

 

Keywords: CHO Cells;  Glutamate-Ammonia Ligase;  Gene Editing;  Antibodies, Monoclonal;  Clone Cells; Pharmaceutical Preparations; Biological Products; Pharmaceutical Services; Drug Development; Cell Line; Bioreactors; Cell Proliferation; Cell Line Development; Cells, Cultured; Recombinant Proteins; Productivity; Biotechnology; Switzerland; Celonic; GS-CHOvolution®; Revvity; CHOSOURCE™; TnT transposon technology; Commercial license agreement; Monoclonal antibodies (mAbs); Complex proteins; Glutamine Synthetase (GS); Chinese Hamster Ovary (CHO-K1) cells; cGMP-compliant; Biomanufacturing; Gene editing; Expression platform; Regulatory recognition; License fee model; Dr. Samanta Cimitan; Contract development and manufacturing services; Dr. Alan Fletcher; INDs (Investigational New Drugs); Collaborations; Biotherapeutics; Contract Development Manufacturing Organization (CDMO); Basel, Switzerland; Heidelberg, Germany; GMP manufacturing facilities

Published by Biotech Newswire

 

Toxys Reports Positive Results from the OECD Ring Trial Validation of ToxTracker in a Peer-Reviewed Article

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OEGSTGEEST, The Netherlands. April 09, 2024 / Biotech Newswire / -- Today Toxys announces the peer-reviewed publication of the positive results from an international interlaboratory validation of ToxTracker©. ToxTracker is an in vitro method that accurately predicts genotoxicity without the use of animals. The results constitute an essential part of the approval process by the OECD for international acceptance of novel methods by regulatory authorities. The evaluation was finalized earlier in the year and data have been submitted to the OECD showing that ToxTracker consistently demonstrates high accuracy and excellent reproducibility of test results, both within and between different laboratories. These data prove that ToxTracker is both robust and reliable. Importantly, ToxTracker can provide insight into the mode of action of genotoxic compounds thereby significantly improving the in vitro safety assessment of novel pharmaceutical products, chemicals, cosmetics and food-related products.

Short background on the validation
The purpose of this study was to validate transferability, robustness and reproducibility of the assay, demonstrate the accuracy of ToxTracker to predict in vivo genotoxicity, and to assess if the mechanistic information from the assay can improve current in vitro genotoxicity testing strategies. The comprehensive evaluation of ToxTracker, was carried out in seven different independent laboratories (Corteva Agriscience, USA; Charles River Laboratories, Canada; Genentech, USA; Labcorp, United Kingdom; Pfizer, USA; Procter & Gamble, USA; Hoffmann-La Roche, Switzerland) using various reference compound libraries recommended by international governmental organizations. The laboratories carried out ToxTracker independently in a blinded manner using 64 chemicals in accordance with OECD guidance document 34.

The results of the validation are presented in the scientific publication “Interlaboratory validation of the ToxTracker assay: “An in vitro reporter assay for mechanistic genotoxicity assessment” by G. Hendriks et al.  that was recently published in Environmental and Molecular Mutagenesis.

"The publication of the ToxTracker validation is a major milestone for the assay and for Toxys. We are fully dedicated to developing and validating innovative in vitro assays to improve the safety assessment of novel medicines and other products without the use of animals. Completion of the validation will further accelerate the adoption of ToxTracker in regulatory applications." – Giel Hendriks, CEO of Toxys.

 

About ToxTracker
ToxTracker is a unique stem cell-based reporter assay for reliable genotoxicity hazard identification. Additionally, ToxTracker provides insight into genotoxic mode-of-action as the assay can discriminate between direct DNA reactivity and indirect genotoxicity related to oxidative stress or protein damage. Furthermore, ToxTracker can be used to discriminate clastogens from aneugens by using one of the various assay extensions (i.e., ToxTracker ACE). Utilization of the ToxTracker platform can help mitigate the risk of regulatory rejection by demonstrating the exact mechanism of genotoxicity.

About Toxys
Toxys is a Dutch biotech company that offers a broad spectrum of innovative in vitro toxicology solutions. Toxys was founded in 2014 as a spin-off from the Leiden University Medical Center and has its state-of-the-art laboratory facilities located at the Leiden Bio Science Park. Toxys is expert in toxicological research with a mission to improve animal-free safety testing by creating mechanistic in vitro chemical safety tests to meet the needs for safer medicines, chemicals and cosmetics. Toxys has developed the unique ToxTracker®, ReproTracker® and ToxProfiler assays. ToxTracker is a high-throughput stem cell-based reporter suite of assays that allows reliable identification of genotoxic carcinogens. ReproTracker is an animal-free test to identify compounds that are toxic to human embryonic development. ToxProfiler is a human cell assay for mechanistic toxicity testing.
Toxys is currently working with the top global pharma, chemical, cosmetics and food companies. Toxys is highly valued for its scientific expertise, high-quality results and timely responsiveness.

 

Contact

Toxys
Giel Hendriks
+31 71 3322470
g.hendriks@toxys.com

 

Keywords: Toxicity Tests; Chemical Safety; Animal Testing Alternatives; Drug-Related Side Effects and Adverse Reactions; Animals; Mutagens; Carcinogens; Aneugens; DNA Damage; Oxidative Stress; DNA; Biological Assay; Consumer Product Safety; Mutagenicity Tests; Pharmaceutical Preparations; Biotechnology; Industry; Food Industry; Food Ingredients; Cosmetics; Netherlands; Toxys; OECD; ToxTracker; Genotoxicity; In vitro method; Regulatory authorities; Validation; Interlaboratory validation; Safety assessment; Pharmaceutical products; Chemicals; Cosmetics; Food-related products; Reference compounds; OECD guidance document 34; Scientific publication; Environmental and Molecular Mutagenesis; Giel Hendriks; Stem cell-based reporter assay; Aneugens; Clastogens; Mechanism of genotoxicity; Leiden Bio Science Park; In vitro toxicology solutions; Animal-free safety testing; Chemical safety tests; ToxTracker®; ReproTracker®; ToxProfiler™; Carcinogens; Embryonic development; Human cell assay; Cosmetics and food companies; High-quality results

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Osteolabs to Present New Clinical Data from Over 2.400 OsteoTest Routine Samples at the WCO-IOF-ESCEO Congress

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New data fully supporting potential for OsteoTest to qualify as new universal diagnostic method for early osteoporosis risk assessment and therapeutic control

KIEL, Germany, April 09, 2024 / Biotech Newswire / -- Osteolabs GmbH, an innovative diagnostic company applying its proprietary CIM (Calcium isotope marker) technology for the early detection of Calcium-related metabolic bone diseases affecting over 1 billion patients worldwide, announced today an oral and poster presentation at the world´s leading clinical conference on bone, joint and muscle health (WCO-IOF-ESCEO) taking place in London from April 11-14, 2024 highlighting new clinical data from over 2.400 OsteoTest routine samples.

The abstract entitled “CALCIUM (CA) ISOTOPE COMPOSITION IN SERUM AND URINE FOR THE ASSESSMENT OF BONE CALCIUM BALANCE (BCAB) – RESULTS FROM A POST-MARKET SURVEILLANCE CLINICAL FOLLOW-UP STUDY ON 2409 PARTICIPANTS” will be presented by Professor Anton Eisenhauer who is a key inventor of the CIM technology and Osteolabs´ Chief Scientific Officer. The related presentation will feature key results from a subset of more than 2.400 samples, which were generated by Osteolabs as part of its clinical diagnostic routine analysis for over 5.000 OsteoTest samples so far. 

“We are very happy to demonstrate that this larger set of routine clinical samples fully supports the potential for OsteoTest to qualify as a new universal diagnostic method for early osteoporosis risk assessment and therapeutic control, “said Prof. Anton Eisenhauer. “All our new results are in full accordance with earlier clinical validation data and related CIM threshold values for Bone Calcium Balance (BCaB).(1) Moreover, all diseases, therapies or diets, positively or negatively affecting the musculoskeletal metabolism, were sensitively reflected by a change of the CIM value in serum and urine.”

As part of the conference, Osteolabs is also proud to announce the joining of PRECCO (PRE-COMPETITIVE CONSORTIUM ON OSTEOPOROSIS AND BONE HEALTH), a new collaboration between the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the World Health Organization (WHO) to improve the epidemiology, screening, diagnosis, measurement, prevention, treatment, rehabilitation and monitoring of osteoporosis and fractures. More information on PRECCO could be found: https://www.osteoporosis.foundation/who-esceo-agreement

 

Details of the upcoming event:

24th Edition of the WCO-IOF-ESCEO Congress (London)
Oral presentation title:
CALCIUM (CA) ISOTOPE COMPOSITION IN SERUM AND URINE FOR THE ASSESSMENT OF BONE CALCIUM BALANCE (BCAB) – RESULTS FROM A POST-MARKET SURVEILLANCE CLINICAL FOLLOW-UP STUDY ON 2409 PARTICIPANTS
Date and Time: April 13, 2024; 2-3 p.m.
Presenter: Prof. Anton Eisenhauer

 

About Osteolabs GmbH
Osteolabs GmbH is an innovative diagnostics company which was spun out from GEOMAR Helmholtz Centre for Ocean Research Kiel and the Helmholtz Association Berlin in 2018. The company deploys its proprietary CIM (Calcium isotope marker) technology for the early detection of Calcium-related metabolic bone diseases affecting over 1 billion patients worldwide with an initial focus on early risk determination of osteoporosis. www.osteolabs.de

 

Contact

Osteolabs GmbH
Kathrin Hagen (Öffentlichkeitsarbeit)
+49 431 990730
kh@osteolabs.de

 

Keywords: Humans; Osteoporosis; Osteoporotic Fractures; Calcium; Osteoarthritis; Bone Diseases, Metabolic;  Calcium Isotopes Fractures, Bone; Bone and Bones;  Osteoporosis; Musculoskeletal Diseases; Biotechnology; Commerce; Germany; Osteolabs; OsteoTest; WCO-IOF-ESCEO Congress; Osteoporosis; Diagnostic method; CIM (Calcium isotope marker) technology; Calcium-related metabolic bone diseases; Kiel, Germany; Oral and poster presentation; Professor Anton Eisenhauer; Bone Calcium Balance (BCaB); Clinical diagnostic routine analysis; Musculoskeletal metabolism; PRECCO (PRE-COMPETITIVE CONSORTIUM ON OSTEOPOROSIS AND BONE HEALTH); European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO); World Health Organization (WHO); Epidemiology; Screening; Diagnosis; Prevention; Treatment; Rehabilitation; GEOMAR Helmholtz Centre for Ocean Research Kiel; Early detection; Risk determination


References:
1. Eisenhauer A et al., Bone Reports 2019; 10:100200; DOI: https://doi.org/10.1016/j.bonr.2019.100200

Published by Biotech Newswire

 

Sartorius and TheWell Bioscience Partner to Enable More Accurate Predictions in Drug Discovery

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  • Collaboration to advance TheWell Bioscience animal-free hydrogel solutions for 3D cell models
  • Solutions address shift from animal-based to more human-relevant organoid models, resulting in more accurate predictions in drug discovery
  • Synergies with Sartorius bioanalytical lab instruments for cell imaging

GÖTTINGEN, Germany, April 9, 2024 / Biotech Newswire / -- The life science group Sartorius and U.S.-based startup TheWell Bioscience have agreed to partner on the further development of hydrogels and bioinks tailored to produce 3D advanced cell models for drug discovery workflows. In addition to this, Sartorius will expand the portfolio of its lab division by distributing TheWell Bioscience's products and invest in a minority shareholding in the company.

TheWell Bioscience is a pioneer in the field of animal-free hydrogels and bioinks, critical components for the creation of 3D biomimicking platforms, also known as 3D cell models, for precision medicine, cell therapy and biomanufacturing. These models are complex biological structures that mimic the organization and function of cells in living organisms, enabling a more accurate prediction of the efficacy, toxicity, and side effects of drugs in humans. As they address the shift from animal-based to more human-relevant organoid models, 3D cell models are a key strategic growth area for Sartorius.

"Sartorius’ lab division is fully focused on helping researchers speed up the development of new drugs with innovative technologies. The offering of TheWell Bioscience seamlessly complements our bioanalytic instruments, cytokines and media products used to grow and analyze a range of 3D spheroid and organoid models. Their hydrogel solutions are highly compatible with our live-cell imaging system for monitoring and analyzing cell health and behavior in real time. By collaborating, we will enable customers to get more relevant insights in less time, accelerating time to market," said Fiona Coats, Head of Marketing at Sartorius’ Lab Products & Services division, who will join the board of directors of TheWell Bioscience as part of the collaboration.

"Our portfolio today encompasses 60 synthetic, room-temperature-stable animal-free hydrogels, bioinks, solutions, and functional assays for biopharma customers to move away from animal-based extracellular matrices for 3D cell models and injectable delivery. The collaboration with Sartorius will broaden our reach in the life science and biopharma market and enable more customers to speed up their research in advanced biomedicine and personalized therapies," said John Huang, founder and CEO of TheWell Bioscience.

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About Sartorius
Sartorius (XETRA: SRT3 | SRT) is a leading international partner of life sciences research and biopharmaceutical manufacturing. With innovative laboratory instruments and consumables, the Group’s Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes. The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically. The company, based in Göttingen, Germany, has a strong global reach with around 60 production and sales sites worldwide. Sartorius regularly expands its portfolio through the acquisition of complementary technologies. In 2023, the company generated sales revenue of around 3.4 billion euros. Currently, around 14,600 employees are working for customers around the globe.
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About TheWell Bioscience
TheWell Bioscience Inc. specializes in providing innovative 3D cell culture platforms to advance personalized medicine. The company manufactures and sells the groundbreaking VitroGel®, a biofunctional, animal-free, synthetic hydrogel system for a wide range of applications, including advanced organoid models, 3D drug screening, and immuno-oncology co-culture for precision medicine. The platform has full high-throughput lab automation adaptability and can be used as an injectable delivery system for cell therapy and wound healing. With the upcoming GMP products and innovative 3D scale-up bioprocessing for 3D cell/protein manufacturing, TheWell Bioscience continues to approach its mission to improve biomedicine for patients worldwide.

 

Contacts

Sartorius
Leona Malorny
Head of External Communications
+49 551 308 4067
leona.malorny@sartorius.com

TheWell Biosciences
Eryka Bantolino
Marketing Specialist
+1 973 855 4955
media@thewellbio.com

 

Keywords: Precision Medicine; Hydrogels; Drug-Related Side Effects and Adverse Reactions; Drug Discovery; Biological Science Disciplines; Cell- and Tissue-Based Therapy; Germany; Sartorius; TheWell Bioscience; Drug discovery; Collaboration; Hydrogel solutions; 3D cell models; Animal-free; Organoid models; Precision medicine; Bioinks; Biomimicking platforms; Toxicity; Side effects; Live-cell imaging system; Cell health; Synthetic hydrogels; Functional assays; Personalized therapies; Laboratory instruments; Cell and gene therapies; Göttingen, Germany; VitroGel®; 3D cell culture platforms; High-throughput lab automation; Inject able delivery system; Cell therapy

Published by Biotech Newswire






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