chapter  19
28 Pages

Process Validation for Cell Culture-Derived Pharmaceutical Proteins

ByAnthony S. Lubiniecki, Michael E. Wiebe, Stuart E. Builder

Decisions by regulatory authorities to permit clinical trials or marketing of cell culture-derived biologicals are based on assessment of benefits and risks associated with use of the proposed product. Risks can be classified into two categories: those associated with potential pharmacological and toxicological effects of the active ingredients and those associated with other components of the product which arise from the method of preparation. The goal of process validation is to demonstrate that real and putative process-associated risks have been reduced to acceptable levels. Validation is only one of many tools to assure product safety, and it is important to remember that it is best used in combination with other tools such as effective process and facility design. Validation is an important tool in the pharmaceutical industry generally, and specifically for manufacture of cell culture biologicals due to their molecular complexity.