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Current Perspectives on Stability of Protein Drug Products during Formulation, Fill and Finish Operations
Author(s) -
Rathore Nitin,
Rajan Rahul S.
Publication year - 2008
Publication title -
biotechnology progress
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.572
H-Index - 129
eISSN - 1520-6033
pISSN - 8756-7938
DOI - 10.1021/bp070462h
Subject(s) - biopharmaceutical , commercialization , protein stability , quality (philosophy) , container (type theory) , critical quality attributes , process (computing) , computer science , product (mathematics) , manufacturing engineering , process engineering , biochemical engineering , quality by design , manufacturing process , risk analysis (engineering) , new product development , engineering , materials science , business , chemistry , microbiology and biotechnology , mechanical engineering , mathematics , biochemistry , philosophy , geometry , epistemology , marketing , composite material , biology , operating system
Commercialization of protein‐based therapeutics is a challenging task in part due to the difficulties in maintaining protein solutions safe and efficacious throughout the drug product development process, storage, transportation and patient administration. Bulk drug substance goes through a series of formulation, fill and finish operations to provide the final dosage form in the desired formulation and container or delivery device. Different process parameters during each of these operations can affect the purity, activity and efficacy of the final product. Common protein degradation pathways and the various physical and chemical factors that can induce such reactions have been extensively studied for years. This review presents an overview of the various formulation‐fill‐finish operations with a focus on processing steps and conditions that can impact product quality. Various manufacturing operations including bulk freeze‐thaw, formulation, filtration, filling, lyophilization, inspection, labeling, packaging, storage, transport and delivery have been reviewed. The article highlights our present day understanding of protein instability issues during biopharmaceutical manufacturing and provides guidance on process considerations that can help alleviate these concerns.