C - Chemistry – Metallurgy – 12 – N
Patent
C - Chemistry, Metallurgy
12
N
C12N 15/12 (2006.01) A61K 38/17 (2006.01) C07H 21/00 (2006.01) C07K 1/14 (2006.01) C07K 14/47 (2006.01) C12N 1/20 (2006.01) C12N 1/21 (2006.01) C12N 15/10 (2006.01) C12P 19/34 (2006.01) C12P 21/00 (2006.01) C12Q 1/34 (2006.01) G01N 33/53 (2006.01) G01N 33/573 (2006.01) A61K 38/00 (2006.01)
Patent
CA 2452241
The present invention relates generally to the production of recombinant human uteroglobin (rhUG) for use a therapeutic in the treatment of inflammation and fibrotic diseases. More particularly, the invention provides processes, including broadly the steps of bacterial expression and protein purification, for the scaled-up production of rhUG according to current Good Manufacturing Practises (cGMP). The invention further provides analytical assays for evaluating the relative strength of in vivo biological activity of rhUG produced via the scaled-up cGMP processes.
Cette invention concerne de manière générale la production d'utéroglobine (rhUG) humaine recombinée, destinée à être utilisée en tant que médicament pour le traitement des inflammations et des pathologies fibrotiques. L'invention concerne plus particulièrement des procédés comprenant globalement une étape d'expression bactérienne et une étape de purification des protéines, qui permettent de produire de la rhUG à grande échelle en respectant les règles des Bonnes Pratiques de Fabrication (BPF). L'invention concerne en outre des systèmes d'analyse permettant d'évaluer le résistance relative de l'activité biologique in vivo de la rhUG produite par ces procédés de production BPF à grande échelle.
Pilon April L.
Welch Richard E.
Claragen Inc.
Clarassance Inc.
Smart & Biggar
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