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Process Of Purification Of Bacterial Polysaccharides

Abstract: The present disclosure provides a process for purification of bacterial polysaccharides, particularly Salmonella polysaccharides, the process comprising: acid hydrolysis; concentrating and diafiltering the cell harvest; treating the solution having polysaccharide with Sodium acetate, SDS, and Ethanol; centrifuging and filtering the solution having polysaccharide; removal of SDS from the solution having polysaccharide by adding KCL; concentrating and diafiltering the solution having polysaccharide; and filtering the solution having polysaccharide to obtain pure polysaccharide. Said process results in improved recovery and minimum impurities in spite of being devoid of calcium chloride, sodium deoxycholate, cationic detergent, enzymes, phenol and chromatography steps. The present disclosure also relates to the purified polysaccharides as well as conjugates and vaccine compositions comprising the purified polysaccharides.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
30 August 2024
Publication Number
42/2025
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application

Applicants

SERUM INSTITUTE OF INDIA PRIVATE LIMITED
212/2, Off Soli Poonawalla Road, Hadapsar, Pune - 411028, Maharashtra, India

Inventors

1. SAMBHAJI SHANKAR PISAL
C/o. SERUM INSTITUTE OF INDIA PRIVATE LIMITED, 212/2, Off Soli Poonawalla Road, Hadapsar, Pune - 411028, Maharashtra, India
2. VINODKUMAR SRINIVAS HARIDASYAM
C/o. SERUM INSTITUTE OF INDIA PRIVATE LIMITED, 212/2, Off Soli Poonawalla Road, Hadapsar, Pune - 411028, Maharashtra, India
3. SHASHANK SHANKAR UPADHYE
C/o. SERUM INSTITUTE OF INDIA PRIVATE LIMITED, 212/2, Off Soli Poonawalla Road, Hadapsar, Pune - 411028, Maharashtra, India
4. SHIVA KUMAR REDDY VENKAT REDDY KOLLURI
C/o. SERUM INSTITUTE OF INDIA PRIVATE LIMITED, 212/2, Off Soli Poonawalla Road, Hadapsar, Pune - 411028, Maharashtra, India

Specification

WE CLAIM:
1. A process of purification of a polysaccharide from a sample comprising crude
5 polysaccharide, the process comprising:
treating the sample with an acid,
concentrating and diafiltering the treated sample;
treating the sample with sodium acetate, sodium dodecyl sulphate (SDS) and ethanol;
centrifuging and filtering the treated sample;
10 removing the SDS from the filtered sample by adding potassium chloride (KCl);
concentrating and diafiltering the sample again; and
filtering the sample to obtain the purified polysaccharide.
2. The process as claimed in claim 1, wherein the polysaccharide is a bacterial
polysaccharide.
15 3. The process as claimed in claim 2, wherein the bacterium is selected from a group
comprising Salmonella, S. typhi, S. paratyphi, S. typhimurium, S. enteritidis, other
non-typhoidal Salmonella, Helicobacter pylori, Chlamydia pneumoniae, Chlamydia
trachomatis, Ureaplasma urealyticum, Mycoplasma pneumoniae, Staphylococcus
spp., Staphylococcus aureus, Streptococcus spp., Streptococcus pyogenes,
20 Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Neisseria
meningitidis, Neisseria gonorrhoeae, Bacillus anthracis, Salmonella spp., Salmonella
typhi, Vibrio cholerae, Pasteurella pestis, Pseudomonas aeruginosa, Campylobacter
spp., Campylobacter jejuni, Clostridium spp., Clostridium difficile, Mycobacterium
spp., Mycobacterium tuberculosis, Treponema spp., Borrelia spp., Borrelia
25 burgdorferi, Leptospira spp., Hemophilus ducreyi, Corynebacterium diphtheria,
Bordetella pertussis, Bordetella parapertussis, Bordetella bronchiseptica,
Hemophilus influenzae, Escherichia coli, Shigella spp., Ehrlichia spp., and Rickettsia
spp.
4. The process as claimed in any one of claims 1 to 3, wherein the bacterium is selected
30 from a group comprising Salmonella typhi, Salmonella paratyphi, Salmonella
typhimurium, Salmonella enteritidis and Salmonella dublin; and wherein the
polysaccharide is Vi polysacchari

Documents

Application Documents

# Name Date
1 202421065851-STATEMENT OF UNDERTAKING (FORM 3) [30-08-2024(online)].pdf 2024-08-30
2 202421065851-FORM 1 [30-08-2024(online)].pdf 2024-08-30
3 202421065851-DRAWINGS [30-08-2024(online)].pdf 2024-08-30
4 202421065851-DECLARATION OF INVENTORSHIP (FORM 5) [30-08-2024(online)].pdf 2024-08-30
5 202421065851-COMPLETE SPECIFICATION [30-08-2024(online)].pdf 2024-08-30
6 202421065851-FORM 18 [04-09-2024(online)].pdf 2024-09-04
7 202421065851-Proof of Right [20-09-2024(online)].pdf 2024-09-20
8 202421065851-FORM-26 [20-09-2024(online)].pdf 2024-09-20
9 202421065851-FORM-9 [13-10-2025(online)].pdf 2025-10-13
10 202421065851-Response to office action [13-11-2025(online)].pdf 2025-11-13