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1. (WO2010146599) PROCESS FOR PURIFICATION OF RECOMBINANT HUMAN GRANULOCYTE COLONY STIMULATING FACTOR
Latest bibliographic data on file with the International Bureau   

Pub. No.:    WO/2010/146599    International Application No.:    PCT/IN2010/000377
Publication Date: 23.12.2010 International Filing Date: 07.06.2010
IPC:
C07K 1/36 (2006.01), C07K 14/535 (2006.01)
Applicants: LUPIN LIMITED [IN/IN]; 159, CST Road, Kalina Santacruz (East) Mumbai - 400 098 Maharashtra (IN) (For All Designated States Except US).
SOMANI, Sandeep [IN/IN]; (IN) (For US Only).
PADMANABHAN, Sriram [IN/IN]; (IN) (For US Only)
Inventors: SOMANI, Sandeep; (IN).
PADMANABHAN, Sriram; (IN)
Agent: MAJUMDAR, Subhatosh; S. Majumdar & CO. 5, Harish Mukherjee Road Kolkata 700 025 (IN)
Priority Data:
865/KOL/2009 16.06.2009 IN
Title (EN) PROCESS FOR PURIFICATION OF RECOMBINANT HUMAN GRANULOCYTE COLONY STIMULATING FACTOR
(FR) PROCÉDÉ DE PURIFICATION DU FACTEUR DE CROISSANCE HÉMATOPOÏÉTIQUE HUMAIN DE RECOMBINAISON
Abstract: front page image
(EN)The present invention describes a novel process for large-scale purification of therapeutic grade quality of recombinant human GCSF from microbial cells, wherein the protein is expressed as inclusion bodies. The Inclusion bodies are solubilized and refolded under redox condition. The Redox condition is provided by using ascorbic acid, dehydroascorbic acid and reduced gluthathione. The process involves the novel use of aqueous two phase extraction step to purify refolded GCSF after removal of denaturant. After this step GCSF is further purified using chromatography techniques for removal of related impurities. The GCSF obtained has good purity and yields which are essential for a production scale process. The host cell related contaminants like proteins, DNA and endotoxins are reduced using the purification processes of the invention.
(FR)L'invention porte sur un nouveau procédé de purification à grande échelle du facteur de croissance hématopoïétique humain de recombinaison (GCSF) de qualité thérapeutique, à partir de cellules microbiennes, la protéine étant exprimée en tant que corps d'inclusion solubilisés et replissés dans des conditions Redox obtenues en utilisant de l'acide ascorbique, de l'acide déshydroascorbique et du glutathion réduit. Le nouveau procédé comporte une étape d'extraction aqueuse en deux phases pour purifier le GCSF replissée après élimination du dénaturant. Après cette étape, le GCSF subit une nouvelle purification recourant à des techniques de chromatographie pour éliminer les impuretés associées. On obtient ainsi du GCSF de bonne pureté avec un rendement élevé essentiel pour la production à grande échelle. Le procédé de purification de l'invention permet ainsi de réduire les protéines contaminantes, l'ADN et les endotoxines de la cellule hôte.
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
African Regional Intellectual Property Organization (BW, GH, GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG).
Publication Language: English (EN)
Filing Language: English (EN)