by Supriya Gupta, PhD, Aleni-Flores Nate, and Elizabet Kaisheva, PhD
Volume 2, Issue 5 (September/October 2003)
An important aspect of developing protein therapeutics is identifying formulation components that stabilize the molecule in order to provide the desired product storage stability. Generally, an aqueous formulation is preferred; however, the instability of proteins, both physical (e.g. aggregation) and chemical (e.g. deamidation and oxidation), often necessitates the development of lyophilized formulations. In these formulations, selection of the appropriate stabilizing cryoprotectants, lyoprotectants, and bulking agents is critical. Accelerated stability studies are typically used to evaluate the effect of a single factor at a time in order to identify the optimum pH, buffer, and stabilizing excipients. This approach is limited in that many independent time-consuming experiments must be run, the results are obtained only at the evaluated set points, and additional experiments are required to assess potential interactions between the evaluated factors…
Citation:
Gupta S, Nate A, Kaisheva E. The Use of Experimental Design Methods in the Development of a High Concentration Lyophilized Formulation for a Humanized Monoclonal Antibody. BioProcess J, 2003; 2(5): 57-63.