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11.发明公开公开(公告)号：US20230149524A1
公开(公告)日：2023-05-18
申请号：US17753248
申请日：2020-09-02
发明人： Rajeev Mhalasakant Dhere , Sambhaji Shankar Pisal , Dattatreya Sarma Annamraju , Nikhil Dattatray Avalaskar , Yogesh Tukaram Hundekari , Anil Pirajirao Taklikar , Sunil Kumar Goel , Chandrashekhar Dwarkanath Kamat , Vishal Bharat Chavan
IPC分类号： A61K39/112 , A61K47/64 , A61P31/04
CPC分类号： A61K39/0275 , A61K47/646 , A61K47/6415 , A61P31/04 , A61K2039/6037
摘要： The present disclosure relates to novel immunogenic monovalent and multivalent polysaccharide-protein conjugate vaccine compositions comprising a polysaccharide selected from Salmonella serovar strains S. typhi; S. paratyphi A; S. typhimurium and S. enteritidis and alternative improved methods of polysaccharide fermentation, polysaccharide purification, polysaccharide-protein conjugation and stable formulation. The present disclosure further relates to methods for inducing an immune response in subjects against Salmonella typhi and non-typhi related diseases and/or for reducing or preventing Salmonella typhi and non-typhi related diseases in subjects using the compositions disclosed herein. The vaccine elicits bactericidal antibodies and is useful for prevention of gastroenteritis, enteric and typhoid fever.
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公开(公告)号：US20190175722A1
公开(公告)日：2019-06-13
申请号：US16327513
申请日：2017-08-24
申请人： Serum Institute of India Private Limited , The Centers For Disease Control and Prevention (CDC)
发明人： Rajeev Mhalasakant DHERE , Sambhaji Shankar PISAL , Jagdish Kamalaji ZADE , Rajendra Narayan SABALE , Ravindra Bapurao KADAM , Abhijeet Sanjeev KAMBLE , Baoming JIANG , Roger GLASS
摘要： 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. Such stable and immunogenic vaccine compositions are made by i) individually adsorbing dose reduced IPV, IRV antigens on alum hydroxide and keeping other antigen(s) unadsorbed or adsorbed on alum phosphate, alum hydroxide, or a combination thereof; and ii) using an order of addition of antigens during blending.
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公开(公告)号：US20230072809A1
公开(公告)日：2023-03-09
申请号：US17910332
申请日：2021-03-09
发明人： 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
摘要： 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.
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14.发明申请公开(公告)号：US20190307875A1
公开(公告)日：2019-10-10
申请号：US16468624
申请日：2017-12-22
发明人： Rémi PALMANTIER , Yolande MISSERI , Caroline DIVEU-SADER , Sunil GAIROLA , Manish GAUTAM , Harish RAO , Umesh SHALIGRAM
IPC分类号： A61K39/02 , A61K39/08 , A61K39/05 , A61K39/29 , A61K39/13 , A61K39/102 , A61K39/39 , A61K9/00
摘要： 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.
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公开(公告)号：US20240309073A1
公开(公告)日：2024-09-19
申请号：US18645135
申请日：2024-04-24
发明人： Rajeev Mhalasakant DHERE , Sambhaji Shankar PISAL , Srinivas Reddy PEDDIREDDY , Digamber Singh CHAHAR , Lenna Ravinda YEOLEKAR , Pankaj Singh CHOUHANA , Nikhil Dattatray AVALASKAR , Adar Cyrus POONAWALA , Cyrus Soli POONAWALLA
IPC分类号： C07K16/10 , A61K9/19 , A61K39/395 , C12N5/078
CPC分类号： C07K16/1081 , A61K9/19 , A61K39/39525 , A61K39/39591 , C07K16/10 , C12N5/0634 , C07K2317/14 , C07K2317/92
摘要： The invention describes an efficient platform for antibody manufacturing and formulation that provides i) cell culture process with improved feeding strategy resulting in high antibody titer between 2 gm/L to 5 gm/L; ii) improved purification process showing optimal percentage recovery, high purity monomer content, minimum aggregation/particulate formation, minimum impurity levels; and iii) high concentration stable liquid formulation with optimal osmolality and low viscosity across different temperature excursions and devoid of aggregation. The preferred antibodies include IgG1 monoclonal antibody specific to the Dengue virus epitope in domain III of the E protein and IgG1 monoclonal antibody specific to the rabies virus surface G glycoprotein.
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16.发明授权公开(公告)号：US11739356B2
公开(公告)日：2023-08-29
申请号：US16611137
申请日：2018-05-03
IPC分类号： C12P19/04 , A61K39/095 , A61K39/00
CPC分类号： C12P19/04 , A61K39/095 , A61K2039/6037
摘要： 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.
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公开(公告)号：US11235054B2
公开(公告)日：2022-02-01
申请号：US16327513
申请日：2017-08-24
申请人： Serum Institute of India Private Limited , The United States of America, as Represented by the Secretary, Department of Health and Human Services
发明人： Rajeev Mhalasakant Dhere , Sambhaji Shankar Pisal , Jagdish Kamalaji Zade , Rajendra Narayan Sabale , Ravindra Bapurao Kadam , Abhijeet Sanjeev Kamble , Baoming Jiang , Roger Glass
IPC分类号： A61K39/00 , C12N7/00 , A61K39/13 , A01N1/02 , A61K39/085 , A61K39/15 , A61K39/12 , A61K39/02
摘要： 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. Such stable and immunogenic vaccine compositions are made by i) individually adsorbing dose reduced IPV, IRV antigens on alum hydroxide and keeping other antigen(s) unadsorbed or adsorbed on alum phosphate, alum hydroxide, or a combination thereof; and ii) using an order of addition of antigens during blending.
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公开(公告)号：US20210187092A1
公开(公告)日：2021-06-24
申请号：US16756227
申请日：2018-10-10
发明人： Rajeev Mhalasakant DHERE , Leena Ravindra YEOLEKAR , Vinit KUMAR , Rohit Bapurav SONAR , Sandeep Dinkar BARASKAR , Rajeev MEHLA , Shashikant Janardan GHODEKAR
摘要： 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.
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19.发明授权公开(公告)号：US10365272B2
公开(公告)日：2019-07-30
申请号：US14808352
申请日：2015-07-24
IPC分类号： G01N33/543 , G01N33/569
摘要： 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.
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20.发明申请公开(公告)号：US20170348411A1
公开(公告)日：2017-12-07
申请号：US15517225
申请日：2015-10-06
发明人： Rajeev Mhalasakant DHERE , Sambhaji Shankar PISAL , Jagdish Kamalaji ZADE , Rajendra Narayan SABALE
CPC分类号： A61K39/13 , A61K39/39 , A61K2039/5252 , A61K2039/5254 , A61K2039/545 , A61K2039/55505 , A61K2039/575 , A61K2039/70 , C12N7/00 , C12N7/045 , C12N7/06 , C12N2770/32334 , C12N2770/32634 , C12N2770/32663 , C12N2770/32671 , Y02A50/383 , Y02A50/386 , Y02A50/388 , Y02A50/39 , Y02A50/392 , Y02A50/412 , Y02A50/466 , Y02A50/484
摘要： 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.
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