The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk-based management for their control

Biotechnology and Bioengineering

Volumn 112, Issue 9, 2015, Pages 1727-1737

  Bracewell, Daniel G ^a   Francis, Richard ^b   Smales, C Mark ^c  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b Francis Biopharma Ltd   (United Kingdom)

^c UNIVERSITY OF KENT   (United Kingdom)

Author keywords

Biopharmaceuticals; Bioprocessing; Host cell proteins; Process related impurities

Indexed keywords

ANTIBODIES; BIOLOGICAL SYSTEMS; CELLS; CYTOLOGY; MASS SPECTROMETRY; PRODUCT DEVELOPMENT; PROTEINS; RISK MANAGEMENT;

BIOPHARMACEUTICALS; BIOPROCESSING; ENZYME LINKED IMMUNOSORBENT ASSAY; HOST CELL PROTEIN; PROCESS-RELATED IMPURITIES; RISK BASED APPROACHES; RISK-BASED MANAGEMENTS; THERAPEUTIC PRODUCTS;

RISK ASSESSMENT;

CELL PROTEIN; HOST CELL PROTEIN; PROTEOME; UNCLASSIFIED DRUG; ANTIBODY; PROTEIN; RECOMBINANT PROTEIN;

ARTICLE; ASSAY; ENZYME LINKED IMMUNOSORBENT ASSAY; HOST CELL; HUMAN; IMMUNOASSAY; MASS SPECTROMETRY; MEASUREMENT; NONHUMAN; PROCESS DEVELOPMENT; PROTEIN ANALYSIS; RISK FACTOR; RISK MANAGEMENT; SERUM; ANIMAL; BIOTECHNOLOGY; CHEMISTRY; CHO CELL LINE; CLASSIFICATION; CRICETULUS; HAMSTER; ISOLATION AND PURIFICATION; PHARMACEUTICS; PROCEDURES; STANDARDS;

ANIMALS; ANTIBODIES; BIOTECHNOLOGY; CHO CELLS; CRICETINAE; CRICETULUS; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; PROTEINS; RECOMBINANT PROTEINS; TECHNOLOGY, PHARMACEUTICAL;

EID: 84937716098     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.25628     Document Type: Article

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