Lessons Learned and Current / Future Challenges in the Formulation and Process Development of Biopharmaceuticals

The advances in biotechnology have led to the development and production of biologic drugs for therapeutic use.  Biologics drugs are very sensitive to aqueous environments and consequently, need to be stabilized via various formulation and other approaches.  Very often, biologics are also stored frozen or lyophilized (freeze-dried) to obtain adequate shelf-life, requiring thawing or reconstitution prior to use.  The process of freezing and/or drying present challenges to the stability of biologic drugs.  The objective of the presentation is to present some of the lessons learned and lingering questions in the development of biopharmaceuticals (monoclonal antibodies and new modalities), with a focus on the effects of freezing and drying on stability of biopharmaceuticals.