How to Scale Lab Cell Therapy Process to cGMP Manufacturing
Jeffery N. Odum, CPIP
There is a paradigm shift occurring in the biomanufacturing space around the advancement of personalized medicine that is creating new challenges for biomanufacturing facility design, both in terms of process technology and facility development approach. Advanced therapy medicinal products are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit, based on a patient-specific target. This new manufacturing approach is in contrast with current biomanufacturing processes for compounds that are synthetically derived (i.e. small molecule) or proteins expressed by cellular systems (i.e. large molecule biopharmaceuticals); our traditional fed-batch approach to product manufacturing. The challenge of how to develop process and facility solutions will be the focus of an exciting interactive workshop at the Biomanufacturing Conference, sponsored by the Biotechnology Community of Practice.
Workshop participants will focus on understanding how a lab scale cell therapy process can be scaled-up to cGMP manufacturing. A case study problem will be given that identifies key elements of the scope; process definition, input/output data, and technology options. During the workshop, participants will have the opportunity to create high-level deliverables that are typically required from a user requirements perspective using this information. Working with subject matter experts and session leaders who will facilitate content information and respond to questions, each Team will break-out to work on defined deliverables and then present to the larger group what they have developed. Whole group discussions will be facilitated, and solution options addressed. The subject matter experts supporting the workshop will provide critique to each Team’s plan and approach. This will be a fast-paced three hours of learning for both experienced participants and those new to the ATMP-based area of biomanufacturing.