Biopharmaceutical Purification Process Development: Identifying Risks and Dealing with Uncertainty

Process and product knowledge is gained throughout the lifecycle of a biopharmaceutical product. Process development teams need to use purification strategies that allow them to respond to new information and accommodate uncertainty. Development of biopharmaceutical purification processes will be discussed with an emphasis on how project teams deal with uncertainty. Strategies focusing on identification of risks and knowledge gaps, and designing and implementing mitigation plans to deal with them will be discussed. Application of these approaches to problems such as dealing with feed stream variability, risks to key raw materials, and issues observed after scale-up will be presented.