Serum Institute of India Private Limited

Swapan Kumar Jana

Rajeev Mhalasakant Dhere

Walmik Karbhari Gaikwad

Sambhaji Shankar Pisal

Subhash Vinayak Kapre

Manish Maheshkumar Gautam

Tushar Dnyaneshwar Joglekar

Hitesh Kumar Malviya

Sunil Mahor

Prashant Shivaji Jadhav

Kapre Subhash Vinayak

Chetan Vilas Joshi

Amar Kumar Srivastava

Asha Dinesh Mallya

Venkata Vamsi Krishna Malepati

Venkata Vamsi Malepati

The present disclosure relates to alternative, cost effective, rapid and simple methods for bacterial capsular polysaccharide (CPS) manufacturing resulting in 1) simultaneous sizing and purification of CPS 2) high CPS yield, 3) improved CPS purity and removal of protein and nucleic acid contaminants, 4) CPS with preserved epitopic conformation and 5) stable and immunogenic polysaccharide-protein conjugate vaccines comprising of said size reduced and purified CPS The method particularly comprises subjecting crude/native bacterial polysaccharide to an oxidizing agent to obtain high purity, high yield and structurally intact CPS having optimal molecular size and other desirable CPS attributes. The method is amenable for commercial scale manufacturing of polysaccharide-protein conjugate vaccines.

Methods for simultaneous fragmentation and purification of bacterial polysaccharides

The present disclosure relates to a method for obtaining purified bacterial polysaccharides. The method comprises simultaneous removal of impurities as well as sizing of bacterial polysaccharides using an acid instead of conventional mechanical sizing methods. The method is simple, rapid and cost effective. The method results in high polysaccharide recovery and low impurity content. The purified polysaccharide obtained by the method of the present disclosure may be used for large scale production of polysaccharide-protein conjugate vaccines.

Method for obtaining purified bacterial polysaccharides

The present invention provides methods for preparation of stable multivalent pneumococcal polysaccharide-protein conjugate vaccine formulations. Instant stable formulations show optimal percent adsorption for each conjugate wherein, aggregation can be prevented by employing i) Individual or separate adsorption for conjugates that otherwise show lower percent adsorption by combined adsorption ii) Histidine-Succinic acid buffer system along with shift in pH from neutral pH to acidic pH iii) a polysaccharide to protein ratio between 0.5 to about 1.4 iv) a six-bladed Rushton type turbine impeller in formulation vessels.

Methods for improving the adsorption of polysaccharide-protein conjugates and multivalent vaccine formulation obtained thereof

A novel alcohol and CTAB free process for purification of capsular polysaccharides, wherein the C-polysaccharide, protein, nucleic acid content of the purified polysaccharide is substantially reduced The said process is cost efficient and less laborious.

Process for preparation of polysaccharides

The invention relates to optimization of culture conditions that utilizes different feed solutions and feeding strategies for improving capsular polyoses (CP) production.

Process of cultivating bacteria for yield improvement of capsular polyoses

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Pune, India

Swapan Kumar Jana