Safeguard your viral vector tech transfer: considerations and case studies

James has worked in the viral vector CDMO space since 2018 and is currently a member of Charles River’s gene therapy CDMO business development team. James obtained a PhD and completed postdoctoral training in cancer gene therapy at the University of Alabama at Birmingham (UAB), studying oncolytic viruses. Afterward, he worked as a research scientist in virology, cell biology, cancer, and parasitology. Based at the viral vector manufacturing site in Rockville, MD, James provides technical support to the business development team, helping to guide client discussions and onboard new projects by collaborating with subject matter experts across various functional groups.

With more than 20 years’ experience working with viral vectors in a GMP environment at various contract development and manufacturing organizations (CDMOs) prior to joining Charles River in 2022, Freda specializes in upstream, fill finish, and cell bank processes.

Leveraging an extensive knowledge base, in her role as Director of Manufacturing Science and Technology (MSAT) for the upstream process at Charles River’s Maryland-based viral vector CDMO center of excellence, Freda is responsible for technology transfer and generates the procedures for the production of viral vectors in a GMP environment.

Freda graduated from the Benguet State University in the Philippines with a bachelor’s degree in Agriculture.

Kevin has been in the manufacturing and technology transfer space for the last 13 years, with the first half of his career spent in large scale production of monoclonal antibodies (mABs) and the latter focussed on the contract development and manufacturing of viral vectors for cell and gene therapies. Kevin has spent the last five years at Charles River’s Maryland-based viral vector CDMO center of excellence specializing in the downstream (purification) aspects of viral vector technology transfer.

Serving as subject matter experts on client projects for cross-functional teams including QA, QC, facilities, and business development, Kevin and his team are responsible for transferring a fully developed downstream purification process from a client, or process development, to GMP.

Kevin graduated from the University of St. Joseph (USJ) with a master's degree in Biochemistry in 2016, preceded by a bachelor's degree in biochemistry from the University of Maryland Baltimore County (UMBC) in 2011.