(695g) Facing Post Process Validation Challenges in Drug Product Manufacturing: One Biological Product, Two Case Studies

Drug product process validation is a key milestone in the successful development of biological therapeutics. Unforeseen post process validation challenges could significantly delay the time to market, and the ability to devise a timely and robust strategy to identify the root cause and mitigate the risks is crucial to course correct. The presentation will highlight the practical approaches that led to overcoming technical and strategic challenges through two case studies for a multi-dose biological drug product. The first case revolves around the loss of preservative at the end of the proposed shelf-life. The second case explores an increase in high molecular mass species in drug product batches containing scaled-up drug substance. The multi-prong mitigation approaches to support post process validation manufacturing, including the use of the Six Sigma DMAIC data-driven improvement cycle, will be discussed.