Monoclonal Antibodies Follow Distinct Aggregation Pathways During Production-Relevant Acidic Incubation and Neutralization

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• 作者：Thomas Skamris ; Xinsheng Tian ; Matthias Thorolfsson…
• 关键词：biopharmaceutics ; formulation ; monoclonal antibody ; protein stability ; small ; angle X ; ray scattering (SAXS)
• 刊名：Pharmaceutical Research
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：33
• 期：3
• 页码：716-728
• 全文大小：2,023 KB
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• 作者单位：Thomas Skamris (1)
  Xinsheng Tian (1)
  Matthias Thorolfsson (2)
  Hanne Sophie Karkov (2)
  Hanne B. Rasmussen (2)
  Annette E. Langkilde (1)
  Bente Vestergaard (1)
  
  1. Department of Drug Design and Pharmacology, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark
  2. Global Research Unit, Novo Nordisk A/S, Novo Nordisk Park 1, 2760, Måløv, Denmark
  
• 刊物类别：Biomedical and Life Sciences
• 刊物主题：Biomedicine
  Pharmacology and Toxicology
  Pharmacy
  Biochemistry
  Medical Law
  Biomedical Engineering
  
• 出版者：Springer Netherlands
• ISSN：1573-904X

文摘

Purpose Aggregation aspects of therapeutic monoclonal antibodies (mAbs) are of common concern to the pharmaceutical industry. Low pH treatment is applied during affinity purification and to inactivate endogenous retroviruses, directing interest to the mechanisms of acid-induced antibody aggregation.