by Andrew J. Racher, PhD
Volume 4, Issue 2 (March/April 2005)
The approval of a new biological drug for therapeutic use requires supporting data from a variety of studies, including those that demonstrate the suitability of the manufacturing process. The regulatory guidance advocates that one of these studies address the issue of cell substrate stability by testing for consistent production of the product of interest by a characterised cell bank, generally the working cell bank (WCB). The study should evaluate stability during cultivation for production by examining a minimum of two time points — at a minimal number of population doublings and at or beyond the limit of in vitro cell age for production. The guidelines state that, “Evaluation of the cell substrate with respect to the consistent production of the intended product of interest should be the primary subject of concern”…
Citation:
Racher AJ. Stability and Suitability of GS-NS0 Cell Lines for Manufacturing Antibodies. BioProcess J, 2005; 4(2): 61-65.