title: Impact of residual impurities and contaminants on protein stability.
abstract: Production of recombinant proteins generates a variety of process-related impurities. The multistep manufacturing processes may introduce many potential contaminants into the final pharmaceutical products. These residual impurities and contaminants can potentially impact the protein stability significantly. In this short review, the authors intend to discuss major sources and types of residual process-related impurities and potential product contaminants, their impact on protein quality/stability, and possible mitigations during product development and manufacturing processes.
authors.affiliation: Pfizer Inc, Chesterfield, Missouri, 63017.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.forename: Arun Alphonse
authors.initials: AA
authors.lastname: Ignatius
authors.forename: Santosh V
authors.initials: SV
authors.lastname: Thakkar
mesh_terms: D001709:Biotechnology; D004340:Drug Contamination; D006801:Humans; D055550:Protein Stability; D011994:Recombinant Proteins / Q000737:chemistry*
chemical_list: D011994:Recombinant Proteins
keywords: biotechnology; deamidation; formulation; oxidation; protein aggregation