Kevin M. Maloney, Biogen Idec, Cambridge, MA
Biopharmaceutical proteins are exposed to variety of solution conditions, solid-liquid and liquid-gas interfaces during their manufacture and final storage condition. Understanding how processing conditions and the final drug product container closure system affect the quality and stability of formulated protein can improve the robustness of the formulation selection process. Case studies are presented that highlight the advantages of integrating formulation and process development, thereby helping to avoid problems that occur during the manufacture and final storage of the drug product.