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"High-risk" host cell proteins (HCPs): A multi-company collaborative view.
Jones, Marisa; Palackal, Nisha; Wang, Fengqiang; Gaza-Bulseco, Georgeen; Hurkmans, Karen; Zhao, Yiwei; Chitikila, Carmelata; Clavier, Severine; Liu, Suli; Menesale, Emily; Schonenbach, Nicole S; Sharma, Satish; Valax, Pascal; Waerner, Thomas; Zhang, Lei; Connolly, Trish.
Afiliação
  • Jones M; GlaxoSmithKline, CMC Analytical, Structure & Function Characterization, Collegeville, Pennsylvania, USA.
  • Palackal N; Regeneron Pharmaceuticals Inc., Protein Biochemistry, Tarrytown, New York, USA.
  • Wang F; Merck & Co. Inc., Analytical Research & Development, Kenilworth, New Jersey, USA.
  • Gaza-Bulseco G; AbbVie Bioresearch Center, Protein Analytics, Worcester, Massachusetts, USA.
  • Hurkmans K; AbbVie Bioresearch Center, Protein Analytics, Worcester, Massachusetts, USA.
  • Zhao Y; Takeda Pharmaceuticals, Pharmaceutical science, Cambridge, Massachusetts, USA.
  • Chitikila C; Janssen R&D LLC, BioTherapeutics Development and Supply, Analytical Development, Bioassay Methods Development, Malvern, Pennsylvania, USA.
  • Clavier S; Sanofi R&D, BioAnalytics, Biologics Development, Vitry-sur-seine, France.
  • Liu S; Biogen, Analytical Development, Cambridge, Massachusetts, USA.
  • Menesale E; Biogen, Analytical Development, Cambridge, Massachusetts, USA.
  • Schonenbach NS; Pfizer, Downstream Process Development, Bioprocess R&D, Chesterfield, Missouri, USA.
  • Sharma S; Bristol Meyers Squibb, Analytical Development, New York, New York, USA.
  • Valax P; Merck KGaA, Global Healthcare Operations, Development and Launch, Biotech Process Sciences, Merck BioDevelopment, Martillac, France.
  • Waerner T; Boehringer Ingelheim Pharma, GmbH & Co. KG, Analytical Development, Biologicals, Biberach, Germany.
  • Zhang L; Bristol Meyers Squibb, Analytical Development, New York, New York, USA.
  • Connolly T; Development Group Phorum, BioPhorum, The Gridiron building, One Pancras Square, London, UK.
Biotechnol Bioeng ; 118(8): 2870-2885, 2021 08.
Article em En | MEDLINE | ID: mdl-33930190
Host cell proteins (HCPs) are process-related impurities that may copurify with biopharmaceutical drug products. Within this class of impurities there are some that are more problematic. These problematic HCPs can be considered high-risk and can include those that are immunogenic, biologically active, or enzymatically active with the potential to degrade either product molecules or excipients used in formulation. Some have been shown to be difficult to remove by purification. Why should the biopharmaceutical industry worry about these high-risk HCPs? What approach could be taken to understand the origin of its copurification and address these high-risk HCPs? To answer these questions, the BioPhorum Development Group HCP Workstream initiated a collaboration among its 26-company team with the goal of industry alignment around high-risk HCPs. The information gathered through literature searches, company experiences, and surveys were used to compile a list of frequently seen problematic/high-risk HCPs. These high-risk HCPs were further classified based on their potential impact into different risk categories. A step-by-step recommendation is provided for establishing a comprehensive control strategy based on risk assessments for monitoring and/or eliminating the known impurity from the process that would be beneficial to the biopharmaceutical industry.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Indústria Farmacêutica Tipo de estudo: Etiology_studies / Risk_factors_studies Idioma: En Revista: Biotechnol Bioeng Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Indústria Farmacêutica Tipo de estudo: Etiology_studies / Risk_factors_studies Idioma: En Revista: Biotechnol Bioeng Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos