Cellular Therapy: From the Research Laboratory to the Manufacturing Facility

by Linda Lemieux
Volume 1, Issue 1 (March 2002)

As you stand on the brink of finalizing your first Investigational New Drug (IND) application for a cellular therapy product, there is always the question looming in the back of your mind. "What did we forget?" Hopefully, the answer is "Nothing." However, it is always good to undergo a review of the standard systems needed in order to transition from research to clinical manufacturing. This article describes an overview of the basic regulatory guidelines and quality systems necessary to begin clinical trials under the regulations of the Food and Drug Administration. However, this should only be considered a guideline, as it does not necessarily address the standards of other regulatory agencies. The investigational product, the clinical indication, and the manufacturing materials used in the investigational product can also change the regulatory requirements needed to proceed with the initiation of clinical trials...

Citation:
Lemieux L. Cellular Therapy: From the Research Laboratory to the Manufacturing Facility. BioProcess J, 2002; 1(1): 56-58.