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”…
Tag: <span>electrophoresis</span>
Glycosylation, a posttranslational modification that adds sugars to proteins, is required by many proteins to function properly. Glycosylation can modulate the biological activities of monoclonal antibodies (MAbs), including certain effector functions in the Fc region of IgG antibodies. Monoclonal antibodies produced at higher expression levels by mammalian cell culture may contain small amounts of nonglycosylated heavy chain (NGHC). Recent cell culture mini-reactor studies have shed light on the process parameters that most affect the occurrence of NGHC, and have greatly minimized NGHC levels in IgG MAb products…