WO2023053030 - AN IMPROVED PROCESS FOR PURIFICATION OF PROTEIN

National phase entry:
Publication Number WO/2023/053030
Publication Date 06.04.2023
International Application No. PCT/IB2022/059238
International Filing Date 28.09.2022
Title **
[English] AN IMPROVED PROCESS FOR PURIFICATION OF PROTEIN
[French] PROCÉDÉ AMÉLIORÉ POUR PURIFICATION DE PROTÉINE
Applicants **
KASHIV BIOSCIENCES, LLC 20, New England Avenue Piscataway, New Jersey 08854, US
Inventors
NARAYAN, Om 802, Anvayaa, Makarba Road, Vejalpur, Ahmedabad, Gujarat Ahmedabad 380051, IN
GUPTA, Tarun Kumar A2/43, Orchid Greenfield Applewoods Township, S.P. Ring Road, Ahmedabad, Gujarat Ahmedabad 380058, IN
THAKKAR, Mayankkumar C501, Setu Vertica, B/H Vodaphone Tower, Gota, Ahmedabad, Gujarat Ahmedabad 382481, IN
UPADHYAY, Roshan Ganeshlal NE/36, Shivanand Apartment, K K Nagar road, Ghatlodia, Ahmedabad, Gujarat Ahmedabad 380061, IN
Priority Data
202121043959   28.09.2021   IN
202121043962   28.09.2021   IN
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Quotation for National Phase entry

Country StagesTotal
China Filing2582
EPO Filing, Examination22046
Japan Filing591
South Korea Filing607
USA Filing, Examination9280
MasterCard Visa

Total: 35106

The term for entry into the National Phase has expired. This quotation is for informational purposes only

Abstract[English] The present invention relates to purification process of pharmacologically active IgG1 containing protein comprising at least affinity chromatography followed by mixed-mode chromatography. The present invention providescytotoxic T-lymphocyte-associated 4-immunoglobulin (CTLA4-Ig) fusion protein by using at least affinity chromatography, mixed-mode chromatography and optionally one or more suitable purification steps that provides purified composition of the fusion protein, substantially free of impurities selected from Pre-Peak, product and process related impurities. Further, the present invention provides highly purified CTLA4-Ig fusion protein with reduced heterogeneity.[French] La présente invention concerne un procédé de purification d'une protéine contenant une IgG1 active du point de vue pharmacologique comprenant au moins une chromatographie d'affinité suivie d'une chromatographie en mode mixte. La présente invention concerne la protéine de fusion de l'immunoglobuline associée à l'antigène 4 de lymphocytes T cytotoxiques (CTLA4-Ig) à l'aide d'au moins une chromatographie d'affinité, une chromatographie en mode mixte et éventuellement une ou plusieurs étapes de purification appropriées qui fournissent une composition purifiée de la protéine de fusion, sensiblement exempte d'impuretés sélectionnées parmi des impuretés associées au produit et au procédé, pré-pic. En outre, la présente invention concerne une protéine de fusion CTLA4-Ig hautement purifiée présentant une hétérogénéité réduite.
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