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.
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
| # | 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 |