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  1. Quality assurance after process changes of the production of a therapeutic antibody.

    Article - En anglais

    Copyright (c) 1996 Elsevier Science B.V. All rights reserved.

    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.

    Mots-clés Pascal : Anticorps monoclonal, Protéine recombinante, Production industrielle, Modification procédé, Fabrication série, Assurance qualité, Contrôle qualité, Sous traitance, Revue bibliographique, Limite tolérable, Validation, Bioéquivalence, Etude cas, Fermentation, Facteur nécrose tumorale alpha, Chimère, Homme, Souris, Rodentia, Mammalia, Vertebrata, Animal

    Mots-clés Pascal anglais : Monoclonal antibody, Recombinant protein, Industrial production, Process modification, Quantity production, Quality assurance, Quality control, Subcontracting, Bibliographic review, Bearable limit, Validation, Bioequivalence, Case study, Fermentation, Tumor necrosis factor alpha, Chimera, Human, Mouse, Rodentia, Mammalia, Vertebrata, Animal

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 97-0078732

    Code Inist : 002B30A08. Création : 21/05/1997.