Manufacturing Cellular Therapy Products in an Academic Facility

by Adrian P. Gee, PhD
Volume 2, Issue 1 (January/February 2003)

Cellular therapy is currently generating great interest in the treatment of a variety of diseases. In turn, this interest has stimulated the Center of Biologics Evaluation and Research of the Food and Drug Administration to examine its regulatory approach to the products used for these therapies. As a result, facilities preparing cell therapy products are now regarded as manufacturers, and are expected to comply with current Good Manufacturing Practices and/or the proposed current Good Tissue Practices. Compliance with these practices can be a culture shock to some academic centers whose background is firmly in research. The FDA has indicated that there is a sliding scale of compliance depending on the phase of the clinical study. The difficulty for centers is deciding where they fall on the compliance scale, as well as determining what changes must be made to come into compliance. This article reviews some of the factors that must be considered when making these decisions...

Gee AP. Manufacturing Cellular Therapy Products in an Academic Facility. BioProcess J, 2003; 2(1): 39-43.