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Viral Clearance Strategies for Cell and Gene Therapies
Combat the challenges associated with CGT development
A unique challenge exists in ensuring viral safety in cell and gene therapy (CGT) products, as the viral vector is essential to both in vivo and ex vivo gene therapies. Even though viral clearance strategies for general biological drug manufacturing and vaccine production are applicable to these products, CGT modalities present unique challenges and considerations.
To ensure the viral safety and contamination control of CGT products, regulatory authorities expect the manufacturing process to employ a comprehensive program of material sourcing, virus testing at appropriate steps of the manufacturing process, and removal and/or inactivation of adventitious viruses and helper viruses.
With over 30 years of experience designing and conducting viral clearance studies, we offer intelligent, tailored study designs and timely reports, resulting in a successful, cost-effective program tailored to the specific needs of your biopharmaceutical.
Viral Clearance Challenges for Gene Therapy Products
Learn about the challenges associated with performing viral clearance (VC) studies on viral vector products, and a database of VC studies generated specifically for gene therapy products.
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