Variability in Cell Collection for IEC Products Discussed with FDA during 2019 Cell Therapy Liaison Meeting
The Food and Drug Administration Cell Therapy Liaison Meeting (FDA CTLM) took place on March 5, 2019 and a summary of the meeting is now online. This meeting was made possible by 13 organizations serving the planning committee, led by Olive Sturtevant and the ISCT North America Legal and Regulatory Affairs Committee. Ms. Sturtevant is also a member of the FACT-JACIE Standards Steering Committee.
Four topics were presented to the FDA, including regulation of biobanking material for future products, collection of mononuclear cells (MNCs) for immune effector cell (IEC) products, minimum characterization criteria for clinical grade induced pluripotent stem cell (iPSC) products, and early interaction mechanisms for tool/device developers.
The presentation and discussion regarding the collection of MNCs for IEC products is particularly timely for many FACT-accredited apheresis facilities. The summary outlines the challenges Dr. Jay Raval presented on behalf of the American Society of Apheresis (ASFA) and the discussion with the FDA afterwards.
This summary may be useful to discussions between apheresis facilities and the commercial manufacturers they work with. It also provides ideas that the field could pursue to reduce variability to a meaningful level that will ensure quality IEC products without limiting the ability of experienced apheresis facilities to care for their patients.
This meeting is just one event regarding this issue in which FACT participated. We will continue to provide updates via the Just the FACTs newsletter as appropriate. In the meantime, we have appreciated the spirit of collaboration that has been demonstrated by commercial manufacturers, healthcare providers, related organizations, and many others.