Document Detail

Quality assurance after process changes of the production of a therapeutic antibody.
MedLine Citation:
PMID:  8997175     Owner:  NLM     Status:  MEDLINE    
Process development for the production of a therapeutic humanised antibody is a very complex operation. It involves recombinant genetics, verification of a strong expression system, gene amplification, characterisation of a stable host cell expression system, optimisation and design of the mammalian cell culture fermentation system and development of an efficient recovery process resulting in high yields and product quality. Rapid progress in the field and the wish of some pharmaceutical companies for outsourcing their production are the driving forces for process changes relatively late in the development phase. This literature survey is aimed at identifying the limits of acceptable process changes in up scaling of the fermentation and down stream processing of biopharmaceuticals and defining the demand in production validation to prove product equivalency and identity of the isolated, purified therapeutic antibody.
J M Brass; K Krummen; C Moll-Kaufmann
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Pharmaceutica acta Helvetiae     Volume:  71     ISSN:  0031-6865     ISO Abbreviation:  Pharm Acta Helv     Publication Date:  1996 Dec 
Date Detail:
Created Date:  1997-02-07     Completed Date:  1997-02-07     Revised Date:  2005-11-17    
Medline Journal Info:
Nlm Unique ID:  0401134     Medline TA:  Pharm Acta Helv     Country:  SWITZERLAND    
Other Details:
Languages:  eng     Pagination:  395-403     Citation Subset:  IM    
LONZA AG, Forschung Biotech, Visp, Switzerland.
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MeSH Terms
Antibodies / therapeutic use*
Antibody Formation*
CHO Cells
Chemistry, Pharmaceutical / standards*
Quality Control
Reg. No./Substance:

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