Analytical Considerations For Biopharmaceuticals During Commercialization

By Elena Gontarz, Ph.D., Manager, Scientific and Technical Affairs; Michael Farris, Senior Manager, Analytical and Formulation Sciences; Sharon Young, Ph.D., Scientific Manager, Analytical and Formulation Sciences; and Maria Johns, Ph.D., Senior Manager, Quality Control, Thermo Fisher Scientific, Pharma Services

When manufacturing biologics, it is critical to validate analytical methods prior to process performance qualification (PPQ). It is an essential step in assuring the quality and safety of pharmaceutical drug products. Performing analytical method validation ensures the methods have the performance capabilities necessary to accurately monitor product quality attributes and process impurities during the production and purification of biological material. As the project approaches the PPQ phase, it is crucial to understand the expectations of regulatory agencies and identify the most efficient ways to validate the analytical methods.