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.
TORONTO (PRWEB) September 28, 2020
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.
Join Sagi Nahum, Director of Innovative Solutions and Senior Scientist, Cognate Bioservices in a live webinar on Tuesday, October 6, 2020 at 11am EDT (4pm BST/UK).
For more information or to register for this event, visit Best Practices for Analytical Method Transfer for Cell Therapy Products.
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