ABSTRACT
Historically, as technologies were developed that allowed biological or biotechnological materials to be produced in large quantities for pharmaceutical use, the statement was frequently heard in both industry and regulatory circles that “The Process Is the Product.” This perspective was based on the understanding that the main production agent-living organisms-produce large quantities of chemically similar material (e.g., proteins) that must undergo a variety of separation steps that can (hopefully) select the greatest yield of the highest purity of a desired molecular entity from the cellularderived milieu. The separation processes used to sort out the one or more target proteins from other, often co-purifying, proteins are optimized, scaled, and validated to reliably achieve the same population of molecular entities from each batch of biologically
9.1 Analytical Characterization of Biomolecular Products ................................ 235 9.2 Physiochemical ProŒle of Biotechnological/Biological Products ................ 237 9.3 Analytical Methods Used in Production Operations .................................... 239 9.4 Methods Used for Product Characterization, Release, and Stability
Testing ........................................................................................................... 241 9.5 QC Release Tests ..........................................................................................245 9.6 Stability Tests................................................................................................ 247 9.7 Product Potency Assays: Why the Ends Do Not Justify the Means .............248 9.8 Comparability Assessment ...........................................................................249 9.9 Development, QualiŒcation, and Validation of a Product-SpeciŒc
Noncompendial Analytical Method ............................................................. 251 9.10 Outline of Test Method Development Strategy ............................................ 252 9.11 Conclusion .................................................................................................... 263 References ..............................................................................................................265
