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1. (WO2018203268) METHOD FOR REMOVAL OF IMPURITIES FROM BACTERIAL CAPSULAR POLYSACCHARIDE BASED PREPARATIONS
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Pub. No.: WO/2018/203268 International Application No.: PCT/IB2018/053069
Publication Date: 08.11.2018 International Filing Date: 03.05.2018
IPC:
C08B 37/00 (2006.01) ,C08L 5/00 (2006.01) ,C08H 1/00 (2006.01) ,A61K 39/095 (2006.01)
C CHEMISTRY; METALLURGY
08
ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
B
POLYSACCHARIDES; DERIVATIVES THEREOF
37
Preparation of polysaccharides not provided for in groups C08B1/-C08B35/110; Derivatives thereof
C CHEMISTRY; METALLURGY
08
ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
L
COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
5
Compositions of polysaccharides or of their derivatives not provided for in group C08L1/ or C08L3/142
C CHEMISTRY; METALLURGY
08
ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
H
DERIVATIVES OF NATURAL MACROMOLECULAR COMPOUNDS
1
Macromolecular products derived from proteins
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39
Medicinal preparations containing antigens or antibodies
02
Bacterial antigens
095
Neisseria
Applicants:
SERUM INSTITUTE OF INDIA PRIVATE LIMITED [IN/IN]; 212/2, Off Soli Poonawalla Road, Hadapsar, Pune Maharashtra 411 028, IN
Inventors:
MHALASAKANT, Dhere Rajeev; IN
SHANKAR, Pisal Sambhaji; IN
SARMA, Annamraju Dattatreya; IN
Agent:
GARG, Vidisha; IN
SHANKER, Archana; IN
WILSON, Neeti; IN
Priority Data:
20172101596105.05.2017IN
Title (EN) METHOD FOR REMOVAL OF IMPURITIES FROM BACTERIAL CAPSULAR POLYSACCHARIDE BASED PREPARATIONS
(FR) PROCÉDÉ D'ÉLIMINATION D'IMPURETÉS DE PRÉPARATIONS À BASE DE POLYSACCHARIDE CAPSULAIRE BACTÉRIEN
Abstract:
(EN) The present invention relates to an improved process for purification of bacterial capsular polysaccharides, more specifically capsular polysaccharides of gram negative bacteria. The process comprises of concentration and dia filtration of harvest, treatment with anionic detergent and strong alkali followed by centrifugation, diafiltration and cationic detergent based precipitation of bacterial polysaccharides. The process results in significant reduction of endotoxin, protein and nucleic acid impurities thereby providing higher recovery of capsular polysaccharide with the desired O-acetyl levels. Said process is scalable, non-enzymatic, and employs fewer purification steps.
(FR) La présente invention concerne un procédé amélioré de purification de polysaccharides capsulaires bactériens, plus particulièrement de polysaccharides capsulaires de bactéries à gram négatif. Le procédé comprend la concentration et la diafiltration de la récolte, le traitement avec un détergent anionique et un alcali fort suivi d'une centrifugation, d'une diafiltration et d'une précipitation à base de détergent cationique de polysaccharides bactériens. Le procédé conduit à une réduction significative d'impuretés de type endotoxine, protéine et acide nucléique, ce qui permet d'obtenir une récupération plus élevée du polysaccharide capsulaire pourvu des taux O-acétyle souhaités. Ledit procédé est évolutif, non enzymatique et utilise moins d'étapes de purification.
Designated States: AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, 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 (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (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, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)