Influence of Production Process and Scale on Quality of Polypeptide Drugs: a Case Study on GLP-1 Analogs

Purpose Manufacturing processes for polypeptide/protein drugs are designed to ensure robust quality, efficacy and safety. Process differences introduced by follow-on manufacturers may result in changes in quality and clinical outcomes. This study investigated the impact of production methods on the...

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Veröffentlicht in:	Pharmaceutical research 2020-07, Vol.37 (7), p.120-120, Article 120
Hauptverfasser:	Staby, Arne, Steensgaard, Dorte Bjerre, Haselmann, Kim F., Marino, Jesper Søndergaard, Bartholdy, Christina, Videbæk, Nicoline, Schelde, Ole, Bosch-Traberg, Heidrun, Spang, Lotte Touborg, Asgreen, Désirée J.
Format:	Artikel
Sprache:	eng
Schlagworte:	Amino Acid Sequence Analysis Animals Antigenic determinants Biochemistry Biological products Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Biopolymers Case studies Cell Line Chemistry, Pharmaceutical Clinical trials Computer Simulation Cricetinae Drug Contamination Drug Stability Epitopes Glucagon-Like Peptides - chemical synthesis Glucagon-Like Peptides - pharmacology Humans Immunogenicity Impurities Kidney - cytology Liraglutide Liraglutide - chemical synthesis Liraglutide - pharmacology Lymphocytes T Manufacturing Medical Law Metals - analysis Molecular Weight Peptides - chemical synthesis Peptides - pharmacology Pharmacology/Toxicology Pharmacy Polypeptides Research Paper Safety T cells Trace metals Type 2 diabetes
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