In this interview, Dr. James Blackwell, Founder and Principal Consultant of The Windshire Group discusses cell therapy technology transfer
“Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.” – BioParm International – Volume 30, pg 14-17.
Excerpt: “Blackwell (Windshire): I’d like to address cell therapies since that is an area we have been doing more work in recently and [is] a growing area. Many cell therapies are personalized medicines and these represent unique challenges from a manufacturing and supply chain standpoint. One of the things that can aid greatly in technology transfer for these types of processes is thinking far in advance about your manufacturing process, facility, and supply chain requirements. Think simplicity, suitability for purpose, and scalability. Many of these types of processes will not scale by volume or by unit operation, but rather in parallel. This means modular thinking and standardization can ease technology transfers. An important aspect of many of these processes is the human element, which is often a larger consideration than it is even for traditional biologicals, such as antibody manufacturing. This makes clear and good procedures, and training and communications, vital to any technology transfer. In judging the success of transfers, having historical data compiled from the process using a continued process verification solution that pulls quality control and batch record data will enable easy comparisons of the receiving site with the sending site, and operator-to-operator performance. These data should be tied to patient outcomes.”
For more information about technology transfer for cell therapy processes – Read the complete interview