G - Physics – 01 – N
Patent
G - Physics
01
N
G01N 33/68 (2006.01) C12N 15/09 (2006.01) C12Q 1/68 (2006.01)
Patent
CA 2574146
The present invention provides a structural characterization platform that can be used to assess the stability of a polyclonal cell line during production, as well as batch-to-batch consistency of the final polyclonal products. The structural characterization platform is based on genetic analyses as well as protein characterization techniques that alone or in combination provide the necessary information to characterize the polyclonal cell line and final products. The collection of different homologous proteins to be analyzed with the platform techniques if for example a recombinant polyclonal antibody or a mixture of monoclonal antibodies.
L'invention concerne une plaque de caractérisation structurelle pouvant servir à évaluer la stabilité d'une lignée cellulaire polyclonale au cours de la production, ainsi que la consistance d'un mélange à l'autre des produits polyclonaux finaux. La plaque de caractérisation structurelle fait intervenir des analyses génétiques ainsi que des techniques de caractérisation de protéines qui, seules ou combinées, fournissent les informations nécessaires pour caractériser la lignées de cellules polyclonales et les produits finaux. Le prélèvement de différentes protéines homologues à analyser au moyen des techniques de plaque, contient par exemple, un anticorps polyclonal recombiné ou un mélange d'anticorps monoclonaux.
Andersen Peter Sejer
Frandsen Torben
Rasmussen Lone Kjaer
Rasmussen Soren Kofoed
Sim & Mcburney
Symphogen A/s
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