Latest news with #KerstinDolph
Business Wire
29-04-2025
- Business
- Business Wire
Charles River Announces Inaugural Advanced Therapy Incubator Program Cohort
WILMINGTON, Mass.--(BUSINESS WIRE)--Charles River Laboratories International, Inc. (NYSE: CRL) today announced the initial cohort of its Charles River Incubator Program (CIP). , the program offers early-stage biotechnology pioneers access to extensive scientific and commercial expertise and a wide ecosystem of discovery, development, and manufacturing capabilities to expedite the development of technologies and life-changing therapies for patients in need. The goal of the Charles River Incubator Program is to form a strong foundation for commercial viability as our participants support the development of life-saving therapeutics. Share The first cohort includes six advanced therapy and technology developers: 64x Bio, Adjuva Bio, Purilogics by Donaldson, Gordian Bio, NanoPalm, and NVI Therapeutics. Participants will benefit from tailored mentorship, consultative regulatory and quality expertise, fit-for-purpose training initiatives, and preferential access to Charles River's global network of facilities. 'We were incredibly impressed with the caliber of applicants for the CIP and are proud of the group chosen to participate in this first round,' said Kerstin Dolph, Corporate Senior Vice President of Global Manufacturing, Charles River. 'The goal of the CIP is to form a strong foundation for commercial viability as our participants support the development of life-saving therapeutics.' Incubating Promising Drug Developers CIP aims to support early-stage biotechnology companies in the discovery, development, and phase-appropriate manufacturing of advanced therapies. Adjuva Bio: Adjuva Bio is developing precision-engineered cell therapies for chronic inflammatory diseases. Adjuva Bio's LogiCAR platform aims to enable programmable cell therapies designed to treat conditions with high unmet need and limited treatment options such as endometriosis and fibrosis. 'At Adjuva Bio, we're expanding the reach of cell therapy to tackle chronic diseases that have been ignored for too long,' said Bishwas Shrestha, Ph.D., Co-Founder, Adjuva Bio. Gordian Bio: Developing novel therapeutics for chronic conditions leveraging an innovative screening platform that measures in vivo efficacy and safety of thousands of novel gene targets simultaneously, in individual animal models of disease. 'Our in vivo screening technology has rapidly identified multiple development candidates in osteoarthritis and heart failure, and is powering partnerships across obesity, lung fibrosis, and cirrhosis,' said Dr. Francisco LePort, Co-Founder and Chief Executive Officer, Gordian Bio. 'We are excited to join CIP as these programs advance toward the clinic.' NanoPalm: Developing in vivo therapies for genetic diseases with an advanced lipid nanoparticle (LNP) manufacturing process designed by NanoPalm's artificial intelligence (AI) platform. 'Being selected for the Charles River Incubator Program marks a significant milestone for NanoPalm as we continue our mission to develop next-generation, accessible gene therapies,' said Dr. Ali Alhasan, Founder and CEO of NanoPalm. 'This collaboration will accelerate our ability to translate groundbreaking research into real-world clinical solutions and reflects how Saudi Arabia is transforming the biotech ecosystem to align with Vision 2030.' NVI Therapeutics: Empowering cell and gene therapy with non-viral gene insertion technology. 'By joining the CIP, NVI Therapeutics aims to accelerate the development of our non-viral gene insertion platform through strategic business development support and expert mentorship,' said Chih-Wen Ni, Ph.D., Founder and CEO, NVI Therapeutics, Inc. 'Access to Charles River's extensive network will be invaluable and collaboration with their world-class team will streamline our preclinical studies and help fast-track our path to the clinic.' Shortlisted ahead of the Company's Cell & Gene Therapy Summit in San Francisco on March 4, 2025, the founders of Adjuva Bio and NVI Therapeutics presented their companies to potential investors in the investment track. Additionally, as part of a commitment to developing a robust biotechnology ecosystem in the Middle East, Charles River previously announced a partnership with Lafana Holding, a leading Saudi investment firm. Lafana joined forces with Charles River to shortlist and select NanoPalm for inclusion in the first CIP cohort, helping to grow the life sciences industry in Saudi Arabia. Enabling Advanced Therapy Technologies Also supporting Charles River's mission to create healthier lives, technology companies Purilogics by Donaldson and 64x Bio are confirmed CIP participants. 64x Bio: An end-to-end platform to accelerate the design and manufacture of next generation biologics including AAV, through the development of novel cell lines and production technologies. '64x is committed to advancing gene therapies by driving down manufacturing costs that further enable unlocking of new indications,' said Alexis Rovner, Co-Founder and Chief Executive Officer at 64x Bio. 'We're also working with partners early to ensure they're starting with the right cell line from day one.' Purilogics by Donaldson: Leveraging Donaldson's long track record of innovative filtration solutions, it has recently expanded into the life sciences sector with multiple bioprocessing acquisitions including its Purilogics platform. Purilogics' Purexa membrane chromatography products aim to enhance efficiency, speed and cost of biologics purification across a variety of applications including pDNA, mRNA, mAbs and other advanced modalities. 'We are excited to participate in CRL's incubator program to test the limits of our membrane chromatography products in a real world setting and demonstrate the full value we can bring to the biomanufacturing process' said Cory Padesky, General Manager of Purilogics by Donaldson. 'In a time where investment in early development is limited, incubator programs like CIP can play a crucial role in supporting early-stage companies as they refine their programs and products,' added Kristen Eisenhauer, Corporate Vice President and Chief Commercial Officer, Charles River. 'The CIP offers access to a concept-to-cure portfolio of capabilities, unique to Charles River, and backed by a team of former regulatory advisors and industry-leading scientists, with a proven track record of success.' In recent years, Charles River has significantly broadened its cell and gene therapy portfolio with several acquisition integrations and expansions to simplify complex supply chains and meet growing demand for plasmid DNA, viral vector, and cell therapy services. Combined with the Company's legacy discovery, safety assessment, and biologics testing capabilities, Charles River offers an industry-leading 'concept to cure' advanced therapies solution. Bringing together subject matter experts, executives, and thought leaders in the CGT space to discuss and navigate critical challenges, register for the European Cell & Gene Therapy Summit 2025 in London on September 16: About Charles River Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit
Yahoo
27-02-2025
- Business
- Yahoo
FibroBiologics and Charles River Announce Completion and Release of CYWC628 Master Cell Bank for the Manufacturing of Fibroblast Cell-based Wound Healing Therapeutic
Master cell bank to be used in manufacturing of CYWC628 drug product to support upcoming clinical trial for diabetic foot ulcers HOUSTON, Feb. 27, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics") and Charles River Laboratories ('Charles River'), a leading, global provider of drug discovery, development, and manufacturing solutions, today announced the completion of FibroBiologics' proprietary master cell bank that will support upcoming clinical trials. Manufactured in accordance with FDA Good Manufacturing Practices (cGMP), the cell bank has successfully passed all required safety testing. FibroBiologics, a clinical-stage biotechnology company with 160+ patents issued and pending for the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, is investigating the potential treatment of chronic diseases using the immunomodulatory and regenerative capabilities of fibroblasts and fibroblast-derived materials. Indications being studied include wound healing, multiple sclerosis, degenerative disc disease, psoriasis, human longevity, and cancer. CYWC628 fibroblast-based therapy targets diabetic foot ulcers, a condition that affects millions of patients worldwide and currently lacks effective long-term treatment solutions. Charles River's state-of-the-art cGMP manufacturing facilities will serve as the production site for the CYWC628 cell banks and drug product for our upcoming phase I/II diabetic foot ulcer clinical trial slated to begin later this year. 'Completing our master cell bank for CYWC628 is a defining moment in our work to advance fibroblast-based cell therapies,' said Pete O'Heeron, CEO of FibroBiologics. 'With this foundation in place, we are progressing on our path to the clinic in 2025 and strengthening our ability to collaborate with research and clinical partners worldwide. Our work with Charles River on this critical step will help ensure that we are fully prepared to scale CYWC628, positioning FibroBiologics at the forefront of fibroblast-based cell therapy innovation.' 'Charles River and FibroBiologics share a common goal of expediting the development of advanced therapies, bringing novel treatments to patients safely and effectively,' said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River. 'The completion of their master cell bank marks a significant milestone in their program, and highlights the power of scientific collaboration. We are proud to enter this next phase of manufacturing together.' For more information, please visit FibroBiologics' website or email FibroBiologics at: info@ Cautionary Statement Regarding Forward-Looking StatementsThis communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning contract development and manufacturing services to be provided under the master services agreement with Charles River and the location where such services will be provided, expected research targets and indications of interest, plans for, and the timing of, clinical trials, FibroBiologics' relationship with Charles River and its ability to collaborate with partners, and FibroBiologics' positioning within the fibroblast-based cell therapy space. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) FibroBiologics' ability to maintain the master services agreement with Charles River and enter into statements of work for manufacturing services; (b) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business; (c) expectations regarding the initiation, progress and expected results of R&D efforts and preclinical studies; (d) the unpredictable relationship between R&D and preclinical results and clinical study results; and (e) the ability of FibroBiologics to successfully prosecute its patent applications. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update, or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. About Charles RiverCharles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit About FibroBiologicsBased in Houston, FibroBiologics is a clinical-stage biotechnology company developing a pipeline of treatments and potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 160+ US and internationally issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, psoriasis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy. For more information, visit Charles River Investor Contact:Todd SpencerCorporate Vice President,Investor Charles River Media Contact:Amy CianciarusoCorporate Vice President,Chief Communications General Inquiries:info@ Investor Relations:Nic JohnsonRusso Partners(212) 845-4242fibrobiologicsIR@ Media Contact:Liz PhillipsRusso Partners(347)
