Best Practices for Analytical Method Transfer for Cell Therapy Products

Cognate BioServices is a leading contract development and manufacturing organization that specializes in cell and cell-mediated gene therapies. Cognate’s state of the art 80,000+ square feet (and growing) cGMP facility is strategically located in Memphis, TN USA – a worldwide air hub for FedEx, enabling Cognate to send and receive shipments from any location in North and South American and Europe within 24 hours, with several choices of carriers. Memphis QC and the innovations teamwork tightly with our process and product development located in Baltimore and transfer production technologies and biological assays between labs daily. It is essential to maintain the validated state of the methods when they are transferred between laboratories and sites. This ensures the same reliable results in the receiving laboratories.

The method of transfer used for this process is primarily known as the Transfer of Analytical Procedures (TAP). The purpose of this procedural transfer is to qualify the receiving laboratories to make use of analytical test procedures developed in other laboratories. This ensures that the receiving laboratories have the capability and needed the knowledge to carry out the transferred analytical methods as intended. FDA released a final guidance document on how to conduct and document the transfer of analytical methods in 2015. In addition, USP has also added a general chapter <1224> on the transfer of analytical procedures, which became official with USP 35 NF-30. This chapter addresses the necessary steps of the procedural transfer process. The objective of this overview is to describe Cognate’s assay transfer procedures following the current guidelines in addition to our unique way and experience.

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Sagi Nahum, Director of Innovative Solutions and Senior Scientist, Cognate Bioservices

Dr. Sagi Nahum earned his Ph.D. in Medical Science from the Faculty of Medicine, Technion Institute, Israel, where he specialized in the areas of Gene Expression, Biostatistics, and Bioinformatics. As a part of his current position at Cognate Bioservices, Dr. Nahum leads the Innovation Lab, developing and validating high throughput capable assays to support the release of clinical and commercial drug products. Dr. Nahum is also focused on the strategic development of cell processing technologies, working with equipment providers and clients on innovative solutions for cell processing including upstream and downstream solutions. Dr. Nahum has an instrumental role in Cognate BioServices’ Analytical Transfer team, helping to execute internal and external processes and method transfers. Before this position, Dr. Nahum incorporated his knowledge at Pluristem Therapeutics as a researcher and Quality control Manager, where he developed and transferred bioassays for product release and research use. Dr. Nahum is a member of the ISO Technical Committee 276 Biotechnology and an author/ collaborator on several articles in the field of genetics and assay development.

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