Summary of DIA Workshop: Comparability Challenges: Regulatory and Scientific Issues in the Assessment of Biopharmaceuticals

On February 3–4, 2009, a DIA Workshop was held to review and discuss comparability challenges and issues for biotechnology-derived pharmaceuticals. The workshop was held in the Washington, DC, area and was attended by representatives from the FDA and biotech and pharmaceutical industries. The expectation was to develop a consensus on which data are necessary to provide assurance of comparability for manufacturing changes made to biotechnology products during different stages of development or postmarketing. Numerous case studies were reviewed and discussed to build on best practices and recognize successful approaches to comparability.