Quality attributes of recombinant therapeutic proteins: An assessment of impact on safety and efficacy as part of a quality by design development approach

Biotechnology Progress

Volumn 28, Issue 3, 2012, Pages 608-622

  Eon Duval, Alex ^a   Broly, Hervé ^a   Gleixner, Ralf ^a  

^a MERCK SERONO S A   (Switzerland)

Author keywords

CQA; Quality attribute; Quality by Design; Safety and efficacy; Therapeutic protein

Indexed keywords

BIOPHARMACEUTICAL PROTEINS; CLINICAL EFFICACY; CQA; CRITICAL QUALITY; IMMUNOGENICITY; MAMMALIAN CELLS; MANUFACTURING PROCESS; PHARMACOKINETICS AND PHARMACODYNAMICS; PROCESS-RELATED IMPURITIES; PRODUCT ATTRIBUTES; QUALITY ATTRIBUTES; QUALITY BY DESIGNS; THERAPEUTIC PROTEIN;

BIOACTIVITY; IMPURITIES; MOLECULES; RATING; RECOMBINANT PROTEINS;

PRODUCT DESIGN;

RECOMBINANT PROTEIN;

ARTICLE; DRUG INDUSTRY; HUMAN; QUALITY CONTROL;

DRUG INDUSTRY; HUMANS; QUALITY CONTROL; RECOMBINANT PROTEINS;

MAMMALIA;

EID: 84862212634     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.1548     Document Type: Article

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