Charles River Introduces Viral Vector Tech Transfer Program
Based on decades of viral vector contract development and manufacturing organization (CDMO) experience, the company has designed a methodical program to drive successful, accelerated process transfer to its Maryland-based viral vector center of excellence (CoE) in as little as nine months.
“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,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River.
New Frameworks
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.
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.
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