A systematic approach to the validation of monoclonal antibody manufacturing processes

Abstract Significant resources are required for the development and validation of complex processes used in the manufacture of monoclonal antibodies for clinical trials and commercial production. For those companies contemplating process validation, regulatory guidelines provide a good starting point, particularly with regard to product safety. However, these guidelines leave open the methodology required to determine suitable process limits that are essential to the validation of the robustness of the process. Using a generalized antibody manufacturing process as a guide, the authors present an approach that provides a reliable basis for process validation. Some typical pitfalls, and how these may be avoided, will be discussed for each major stage of validation.