Compatibility Assessment Of A Model Monoclonal Antibody Formulation In Glass And Blow–Fill–Seal Plastic Vials

Summary: 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 biologics. The company also has optimized BFS processes and its Advasept plastic container system for the manufacture of sterile injectable products.

The Advasept container system provides significant advantages over traditional, commercial, glass container systems for the parenteral/injectable market space. Benefits include reduced container breakage and an absence of glass delamination. The automated aseptic filling design of BFS advanced aseptic technology drastically reduces the risks associated with traditional aseptic manufacturing. BFS forms, fills, and seals vial contents in less than 15 seconds within a closed, class A environment, by which it reduces the risk of contamination from both microbial and foreign particulate sources.

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