Charles River Launches Viral Vector Tech Transfer Program to Safeguard Gene Therapy Development
Charles River Laboratories has launched new Modular and Fast Track viral vector technology transfer frameworks. These frameworks are designed for seamless tech transfer to its Maryland-based viral vector Center of Excellence within nine months. The Fast Track framework allows for straightforward transfers when no process changes are needed, while the Modular framework supports complex transfers requiring process modifications. Both frameworks aim to prevent costly delays and ensure program success. Charles River's CoE offers full-scale capabilities for adeno-associated virus, adenovirus, lentivirus, and retrovirus production and integrates their concept-to-cure portfolio from discovery to commercialization.
- Introduction of Modular and Fast Track tech transfer frameworks to ensure seamless process transfer within nine months.
- Frameworks designed to prevent costly and time-consuming delays in gene therapy development.
- Full-scale, in-house plasmid DNA and viral vector production capabilities.
- Capability to manage tech transfers for adeno-associated virus, adenovirus, lentivirus, and retrovirus.
- Integrated 'concept to cure' portfolio spanning discovery through commercialization.
- Recent expansions and acquisitions to meet growing demand for plasmid DNA, viral vector, and cell therapy services.
- No specific clinical data or financial metrics provided to validate the efficacy of the new frameworks.
- Potential risks associated with process changes in the Modular framework may still lead to unforeseen delays.
- High dependency on the successful execution of the new frameworks to maintain market competitiveness.
- No clear mention of the cost implications for clients using these new frameworks.
- Possible concerns over scalability and actual impact on accelerating commercialization.
Fast Track and Modular frameworks facilitate product development continuity via seamless process transfer to the Company’s viral vector Center of Excellence
Charles River’s viral vector tech transfer program offers phase-appropriate and customizable frameworks to yield exceptional stability, helping to avoid costly and time-consuming program delays. The Fast Track framework enables a streamlined approach to tech transfer when no process changes are required. The Modular framework facilitates fully customizable tech transfer for more complex scenarios when processes are not yet fully developed or process changes are required, such as switching a cell line, plasmid supply, and/or assay/analytical development, bolstered by Charles River’s premier testing platform. Both frameworks enable reliable transfer to the viral vector CoE, avoiding preventable delays and safeguarding continued program success.
With full-scale, in-house plasmid DNA and viral vector production capabilities, Charles River can efficiently manage tech transfers for a wide range of viral vectors, such as adeno-associated virus (AAV), adenovirus, lentivirus, and retrovirus. Once technology transfer has been initiated, developers gain access to Charles River’s integrated concept to cure portfolio, spanning discovery through safety assessment and commercialization.
Explore Flexible Tech Transfer at the BIO International Convention
Charles River will showcase its viral vector tech transfer framework at the BIO International Convention, June 3-6, 2024 in
During the conference, Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services, will take to the BioProcess International Theater stage on June 4 at 2:00 p.m. to present, Seamless Viral Vector Tech Transfer at Any Phase: Offering Stability in Times of Change.
Viral Vector Manufacturing Services
Charles River’s viral vector center of excellence offers viral vector tech transfer and manufacturing to support any stage of the drug development lifecycle, from research-grade viral vector manufacturing for in vitro and in vivo studies to commercial-scale GMP manufacturing. In recent years, the Company has significantly broadened its cell and gene therapy portfolio with several acquisitions and expansions to simplify complex supply chains and meet the growing demand for plasmid DNA, viral vector, and cell therapy services.
Watch the latest expert roundtable, Streamlining Cell and Gene Therapy Scalability: Progress Towards a Gold Standard, on-demand, and gain insights from a development, manufacturing, and testing perspective: https://bit.ly/3UCX8LW
Approved Quotes
- “A reliable, end-to-end CDMO is critical for continuity of supply and program efficiency. Charles River’s viral vector technology transfer program provides gene therapy developers with a cohesive concept-to-cure solution portfolio, fine tuned over decades supporting advanced therapy clients from discovery to commercialization and every step in between.” – Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River
- “Viral vector manufacturing and tech transfer is complex, requiring precision and accuracy to avoid costly and time-consuming program delays. Meticulously built to provide a seamless tech transfer at any phase, the viral vector tech transfer program provides stability in times of change.” – Ramin Baghirzade, PhD, Senior Director, Global Head Commercial, Gene Therapy CDMO Services, Charles River
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 www.criver.com.
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Investor Contact:
Todd Spencer
Corporate Vice President,
Investor Relations
781.222.6455
todd.spencer@crl.com
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Chief Communications Officer
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Source: Charles River Laboratories International, Inc.
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