Methods of manufacturing a biologic using a stable storage...

C - Chemistry – Metallurgy – 07 – K

Patent

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C07K 1/00 (2006.01) C07K 1/30 (2006.01) C07K 16/00 (2006.01) C12M 1/00 (2006.01) A61K 38/16 (2006.01) A61K 39/395 (2006.01) C12P 1/00 (2006.01) C12P 21/00 (2006.01)

Patent

CA 2702048

The present invention is directed to methods of isolating and purifying protein from a bioreactor process. The invention relates to employing a protein phase separation methodology to isolate or purify protein product in the forms of solid, semi-solid, or suspension during a protein manufacturing purification process as a stable storage intermediate. This approach is designed to allow the isolated protein product (purified or partially purified) to be stored over an extended period of time prior to further protein purification steps.

La présente invention concerne des procédés permettant d'isoler et de purifier une protéine à partir d'un traitement par bioréacteur. L'invention concerne l'emploi d'une méthodologie de séparation de phase protéique pour isoler ou purifier une substance protéique sous forme de solide, de semi-solide ou de suspension au cours d'un processus de purification industrielle de protéine en tant que produit intermédiaire de stockage stable. Cette approche est conçue pour permettre le stockage de la substance protéique isolée (purifiée ou partiellement purifiée) sur une période de temps étendue avant des étapes de purification supplémentaires de la protéine.

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