by Lilia Bi, PhD
Volume 5, Issue 4 (Winter 2006)
Recombinant DNA-transduced cellular products encounter the product development and regulatory issues of both gene therapy and cellular therapy products. The characterization of recombinant DNA-transduced cellular products remains highly challenging for both sponsors and regulatory agencies. The regulatory concerns and product testing for such cellular products are similar to those for all biologicals. These concerns include the demonstration of product safety, identity, purity, and potency; the control of the manufacturing process to ensure the consistency of product manufacturing under a proper quality control program; and the demonstration of reproducibility and consistency of product lots by means of defined product lot release testing criteria…
Citation:
Bi L. Considerations for Characterization and Comparability of Recombinant DNA-Transduced Cellular Products. BioProcess J, 2006; 5(4): 27-29. https://doi.org/10.12665/J54.Bi