by Kathy Schonely, Cathleen Afable, Vladimir Slepushkin, MD, PhD, Xiaobin Lu, PhD, Kris Andre, Jessica Boehmer, Karen Bengtson, Michael Doub, Reuben Cohen, David Berlinger, Tatiana Slepushkina, Ziping Chen, PhD, Yuexia Li, PhD, Gwendolyn Binder, PhD, Brian Davis, PhD, Laurent Humeau, PhD, and Boro Dropulic, PhD
Volume 2, Issue 4 (July/August 2003)
The first HIV-based lentiviral vector to be used in humans, VRX496, is currently being tested in Phase I clinical trials (initiated in January 2003). With each new therapeutic comes the need to establish quality control (QC) testing designed specifically for that product. The QC testing for VRX496 was developed in accordance with the Code of Federal Regulations (CFR) 21 for pharmaceutical and bulk chemical GMPs, Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993) from the Center for Biologics Evaluation and Research (CBER) at FDA, and the United States Pharmacopeia (USP) 1046 for Cell and Gene Therapy Products. This report describes the QC testing of lot VRX496V02-009 of our clinical grade vector, which is being used in an ongoing clinical trial evaluating the first lentiviral gene therapy vector in humans. All assays are performed according to established standard operating procedures (SOPs) and in accordance with the principles of cGMP regulations…
Citation:
Schonely K, Afable C, Slepushkin V, Lu X, Andre K, Boehmer J, Bengtson K, Doub M, Cohen R, Berlinger D, Slepushkina T, Chen Z, Li Y, Binder G, Davis B, Humeau L, Dropulic B. QC Release Testing of an HIV-1 Based Lentiviral Vector Lot and Transduced Cellular Product. BioProcess J, 2003; 2(4): 39-47.