Patents Assigned to Serum Institute of India
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Patent number: 11793869Abstract: The present invention is directed to improved methods of Enterovirus inactivation by formaldehyde in presence of tromethamine buffer resulting in maximum recovery of D-antigen. Subsequent adsorption of said sIPV on aluminium hydroxide provides significantly dose reduced sIPV compositions.Type: GrantFiled: October 10, 2019Date of Patent: October 24, 2023Assignee: Serum Institute Of India Pvt Ltd.Inventors: Rajeev Mhalasakant Dhere, Sambhaji Shankar Pisal, Jagdish Kamalaji Zade, Rajendra Narayan Sabale, Hitesh Kumar Malviya, Sunil Mahor, Chetan Vilasrao Joshi
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Patent number: 11739356Abstract: 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.Type: GrantFiled: May 3, 2018Date of Patent: August 29, 2023Assignee: Serum Institute of India Private LimitedInventors: Rajeev Mhalasakant Dhere, Sambhaji Shankar Pisal, Dattatreya Sarma Annamraju
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Patent number: 11660333Abstract: Stable lyophilized immunogenic compositions include inter alia live attenuated recombinant flaviviruses, more preferably live attenuated recombinant dengue viruses, at least one carbohydrate, at least one amino acid and is particularly amenable to rapid freeze-drying treatments wherein, the composition preserves desired characteristics of a virus, including virus viability, immunogenicity and stability. The immunogenic composition is devoid of preservatives, polymers and surfactants. The methods for manufacturing the stable lyophilized immunogenic compositions are also provided.Type: GrantFiled: October 10, 2018Date of Patent: May 30, 2023Assignee: Serum Institute of India Private LimitedInventors: Rajeev Mhalasakant Dhere, Leena Ravindra Yeolekar, Vinit Kumar, Rohit Bapurav Sonar, Sandeep Dinkar Baraskar, Rajeev Mehla, Shashikant Janardan Ghodekar, Cyrus Soli Poonawalla, Adar Cyrus Poonawalla
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Publication number: 20230117167Abstract: Described herein are modified SARS-CoV-2 coronaviruses. These viruses have been recoded, for example, codon deoptimized or codon pair bias deoptimized and are useful for reducing the likelihood or severity of a SARS-CoV-2 coronavirus infection, preventing a SARS-CoV-2 coronavirus infection, eliciting and immune response, or treating a SARS-CoV-2 coronavirus infection.Type: ApplicationFiled: January 27, 2021Publication date: April 20, 2023Applicants: CODAGENIX INC., SERUM INSTITUTE OF INDIA PRIVATE LIMITEDInventors: Steffen Mueller, John Robert Coleman, Ying Wang, Chen Yang
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Publication number: 20230072809Abstract: The present disclosure relates to immunogenic compositions comprising tetanus, diphtheria, and acellular pertussis (Tdap) antigens, and a toll-like receptor 9 (TLR9) agonist, such as oligonucleotide comprising an unmethylated cytidine-phospho-guanosine (CpG) motif. The immunogenic compositions may further comprise an aluminum salt adjuvant to which the Tdap antigens are adsorbed. The immunogenic compositions are suitable for active booster immunization against tetanus, diphtheria, and pertussis in an individual in need thereof.Type: ApplicationFiled: March 9, 2021Publication date: March 9, 2023Applicants: Dynavax Technologies Corporation, Serum Institute of India Private LimitedInventors: John D. CAMPBELL, Robert L. COFFMAN, Randall N. HYER, Robert S. JANSSEN, David NOVACK, Martin GOHLKE, Maureen URBAN, Sunil GAIROLA, Umesh SHALLIGRAM, Manish GAUTUM, Harish RAO
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Patent number: 11235054Abstract: Stable, immunogenic combination vaccine(s) comprising a mixture of antigens for prevention and prophylaxis of infections caused by Rotavirus, Poliomyelitis virus, Haemophilus influenzae, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis and Hepatitis B virus. A multivalent combination vaccine comprises i) significantly dose-reduced Salk-IPV or Sabin-IPV (IPV) antigens prepared by methods of formaldehyde inactivation and alum hydroxide adsorption resulting in maximum D-antigen recovery; ii) Injectable heat inactivated Rotavirus antigen(s) providing broad cross-protective immunity among human rotavirus strains; iii) Hib PRP-carrier protein conjugate having improved stability and immunogenicity; iv) whole cell pertussis antigen with improved immunogenicity and stability; and v) Homogenous fractions of Diphtheria and Tetanus toxoids.Type: GrantFiled: August 24, 2017Date of Patent: February 1, 2022Assignees: Serum Institute of India Private Limited, The United States of America, as Represented by the Secretary, Department of Health and Human ServicesInventors: Rajeev Mhalasakant Dhere, Sambhaji Shankar Pisal, Jagdish Kamalaji Zade, Rajendra Narayan Sabale, Ravindra Bapurao Kadam, Abhijeet Sanjeev Kamble, Baoming Jiang, Roger Glass
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Patent number: 11179453Abstract: An immunogenic composition comprising of Diphtheria toxoid antigen (D), tetanus toxoid (T) antigen, Hepatitis B surface antigen (HBsAg), inactivated whole-cell B. pertussis (wP) antigen, Haemophilus influenzae type B (Hib) capsular saccharide conjugated to a carrier protein, Inactivated Polio Virus (IPV) antigen and additionally one or more antigens and the method of preparing the same. A fully liquid combination vaccine, showing improved immunogenicity, reduced reactogenicity and improved stability. Improved methods of formaldehyde inactivation, improved adsorption profile of Diphtheria toxoid antigen (D), tetanus toxoid (T) antigen and Hepatitis B (HepB) surface antigen adsorbed individually onto aluminium phosphate adjuvant, minimum total aluminum content (Al3+) and optimized concentration of 2-phenoxyethanol (2-PE) as preservative.Type: GrantFiled: July 13, 2018Date of Patent: November 23, 2021Assignee: SERUM INSTITUTE OF INDIA PVT LTDInventors: Rakesh Kumar, Inder Jit Sharma, Anil Vyankatrao Shitole, Manohar Doddapaneni, Hitt Jyoti Sharma
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Patent number: 10729780Abstract: 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.Type: GrantFiled: June 3, 2016Date of Patent: August 4, 2020Assignee: Serum Institute of India Private Ltd.Inventors: Rajeev Mhalasakant Dhere, Hitesh Kumar Malviya, Swapan Kumar Jana, Sambhaji Shankar Pisal, Asha Dinesh Mallya, Sunil Mahor, Manish Maheshkumar Gautam, Chetan Vilas Joshi, Venkata Vamsi Krishna Malepati, Prashant Shivaji Jadhav
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Patent number: 10485862Abstract: The present invention is directed to improved methods of Enterovirus inactivation by formaldehyde in presence of tromethamine buffer resulting in maximum recovery of D-antigen. Subsequent adsorption of said sIPV on aluminium hydroxide provides significantly dose reduced sIPV compositions.Type: GrantFiled: October 6, 2015Date of Patent: November 26, 2019Assignee: SERUM INSTITUTE OF INDIA PVT LTDInventors: Rajeev Mhalasakant Dhere, Sambhaji Shankar Pisal, Jagdish Kamalaji Zade, Rajendra Narayan Sabale
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Publication number: 20190307875Abstract: The invention relates to the use of a polypeptide derived from the adenylate cyclase of a Bordetella sp. (CyaA-derived polypeptide) by deletion of a segment of at least 93 amino acid residues, in particular a polypeptide derived from CyaA of Bordetella pertussis, as an immunomodifying antigen of the TH1/TH17-oriented immune response in an immunogenic composition. The invention relates to a vaccine candidate comprising such CyaA-derived polypeptide, either in an acellular immunogenic composition for active immunization against a condition causally related to the infection of a host by Bordetella sp. or in a combination composition encompassing said acellular immunogenic composition.Type: ApplicationFiled: December 22, 2017Publication date: October 10, 2019Applicants: GENKYOTEX, SERUM INSTITUTE OF INDIA PRIVATE LIMITEDInventors: RĂ©mi PALMANTIER, Yolande MISSERI, Caroline DIVEU-SADER, Sunil GAIROLA, Manish GAUTAM, Harish RAO, Umesh SHALIGRAM
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Patent number: 10365272Abstract: The present disclosure relates to the field of immunoassays for Gram negative bacteria, in particular N. meningitidis. The disclosure provides a simple and affordable immunoassay to quantitate polysaccharides in meningococcal vaccines for the evaluation of antigen content and lot-to-lot manufacturing consistency. The inventors have found a Sandwich ELISA that can be applicable for the quantitation and identification of N. meningitidis serogroup X polysaccharide in a multivalent meningococcal polysaccharide-protein conjugate vaccine as well as in a multivalent meningococcal plain polysaccharide vaccine. Said assay employs a polyclonal antibody as capture antibody and a novel monoclonal antibody against serogroup X polysaccharide as detection antibody. Further the assay is rapid, robust and reproducible.Type: GrantFiled: July 24, 2015Date of Patent: July 30, 2019Assignee: SERUM INSTITUTE OF INDIA PRIVATE LIMITEDInventors: Kale Sameer Manohar, Sharma Pankaj Keshav, Gairola Sunil Jagdishprasad
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Patent number: 10233231Abstract: This invention provides an improved process for manufacturing a Rabies monoclonal antibody (HuMab 17C7) that results in low osmolality, minimum secondary metabolites like ammonia and lactate, enhanced cell growth and productivity, minimum aggregation or degradation of monoclonal antibody during purification, thereby improving potency of monoclonal antibody (HuMab 17C7) as compared to human rabies immunoglobulin (hRIG).Type: GrantFiled: July 6, 2016Date of Patent: March 19, 2019Assignee: Serum Institute of India Private LimitedInventors: Dhere Rajeev Mhalasakant, Pisal Sambhaji Shankar, Peddi Reddy Srinivas Reddy, Singh Digamber Chahar, Pardeep Gupta
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Publication number: 20180161445Abstract: 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.Type: ApplicationFiled: June 3, 2016Publication date: June 14, 2018Applicant: Serum Institute of India Privated Ltd.Inventors: Rajeev Mhalasakant DHERE, Hitesh Kumar MALVIYA, Swapan Kumar JANA, Sambhaji Shankar PISAL, Asha Dinesh MALLYA, Sunil MAHOR, Manish Maheshkumar GAUTAM, Chetan Vilas JOSHI, Venkata Vamsi Krishna MALEPATI, Prashant Shivaji JADHAV
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Patent number: 9878029Abstract: 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.Type: GrantFiled: May 9, 2011Date of Patent: January 30, 2018Assignee: Serum Institute of India Private LimitedInventors: Subhash Kapre, Swapan Kumar Jana, Tushar Dnyaneshwar Joglekar
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Patent number: 9700615Abstract: The present invention is directed to methods for administering antigenic material to a patient as a vaccine against an infection comprising providing both an antigenic material specific to the desired immunological response desired plus an adjuvant comprised of a peptide of a sequence derived from the sequence of pneumococcal surface adhesin A protein (PsaA). Preferably the peptide comprises a sequences derived from one or more sequences of PsaA that contain the epitope regions or contiguous amino acids of SEQ ID NOs 1 or 2. The invention is also directed to vaccine compositions containing adjuvant of the invention and also adjuvant compositions of the invention.Type: GrantFiled: May 13, 2013Date of Patent: July 11, 2017Assignee: Serum Institute of India Pvt. Ltd.Inventor: Subhash V. Kapre
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Patent number: 9580734Abstract: The instant invention provides improved culture, fermentation and purification conditions for preparing Neisseria meningitidis polysaccharides. The invention in particular relates to a novel fermentation medium, optimal feed solution addition strategies and an improved purification process devoid of any chromatographic methods for obtaining high yield of Neisseria meningitidis X polysaccharide.Type: GrantFiled: November 18, 2013Date of Patent: February 28, 2017Assignee: Serum Institute of India Private Ltd.Inventors: Pisal Sambhaji Shankar, Chilukuri Srinivas Reddy, Peddireddy Srinivas Reddy
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Patent number: 9283270Abstract: Thermostable polysaccharide based lyophilized vaccines are disclosed, particularly polysaccharide-protein conjugate vaccines and methods for preparation thereof. In an exemplary embodiment, a stabilized vaccine composition consists essentially of at least one polysaccharide-protein conjugate, at least one amorphous excipient, and a buffer component.Type: GrantFiled: January 18, 2013Date of Patent: March 15, 2016Assignee: Serum Institute of India Ltd.Inventors: Subhash Vinayak Kapre, Sambhaji Shankar Pisal, Nikhil Dattatray Avalaskar
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Patent number: 9249439Abstract: The invention relates to optimization of culture conditions that utilizes different feed solutions and feeding strategies for improving capsular polyoses (CP) production.Type: GrantFiled: December 15, 2011Date of Patent: February 2, 2016Assignee: Serum Institute of India Ltd.Inventors: Kapre Subhash Vinayak, Swapan Kumar Jana, Amar Kumar Srivastava
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Patent number: 9198977Abstract: The invention provides immunogenic polysaccharide protein conjugates comprising capsular polysaccharides from N. Meningitidis serogroup X and methods for preparation thereof. The present invention relates to N. meningitidis X saccharide-carrier protein conjugates prepared by a conjugation reaction. Accordingly, the instant invention relates to multivalent meningococcal polysaccharide protein conjugate composition comprising capsular saccharide from serogroups X and at least one capsular saccharide from A, C, W135 and Y wherein, i) polysaccharides A C W135 X are sized mechanically whereas polysaccharide Y is sized chemically, ii) all saccharide are conjugated to carrier protein via a linker with a cyanylation conjugation chemistry iii) all saccharide to protein ratios in final conjugates are between 0.2-0.6 and iv) at least two different carrier proteins selected from the group consisting of TT, DT and CRM197 are utilized.Type: GrantFiled: January 29, 2013Date of Patent: December 1, 2015Assignee: Serum Institute of India Ltd.Inventors: Subhash Vinayak Kapre, Sambhaji Shankar Pisal
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Publication number: 20140342411Abstract: The invention relates to optimization of culture conditions that utilizes different feed solutions and feeding strategies for improving capsular polyoses (CP) production.Type: ApplicationFiled: December 15, 2011Publication date: November 20, 2014Applicant: SERUM INSTITUTE OF INDIA LTD.Inventors: Kapre Subhash Vinayak, Swapan Kumar Jana, Amar Kumar Srivastava