Fitting a Square Peg into a Round Hole: Methods Development, Qualification and Validation for Complex Biological Products

by Katharine A. Miller, PhD
Volume 6, Issue 2 (Summer 2007)

Manufacturers of biological products have come to accept that it makes sense, from both a business as well as a regulatory perspective, to address GMP compliance issues with bioprocessing methods as early as possible in product development. Logically, this same reasoning would also apply to the associated analytical methods used to characterize the product; however, companies still frequently leave methods optimization and validation until later in the developmental timeline which can expose them to unexpected regulatory challenges. In addition, as therapeutics increase in complexity (e.g., cell therapies, transgenics), it raises the likelihood that product characterization will be assessed by novel and increasingly intricate assays‚ÄĒmaking it difficult to follow a ‚Äúone size fits all‚ÄĚ approach to method selection, development and validation‚Ķ

Citation:
Miller KA. Fitting a Square Peg into a Round Hole: Methods Development, Qualification and Validation for Complex Biological Products. BioProcess J, 2007; 6(2): 30-36. http://dx.doi.org/10.12665/J62.Miller