Compatibility Assessment of a Model Monoclonal Antibody Formulation in Glass and Blow-Fill-Seal Plastic Vials

摘要

Blow-fill-seal (BFS) technology has been recognized by the industry as an advanced aseptic solution (1-3). Catalent Pharma Solutions has been commercially supplying sterile BFS products to the pharmaceutical industry for decades, primarily in the respiratory and topical ophthalmic markets. Such product formulations range from simple solutions to emulsions with drug substances from classical small molecules to large complex proteins such as biologies. The company also has optimized BFS processes and its Advasept plastic container system for the manufacture of sterile injectable products.