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公开(公告)号：US11660333B2
公开(公告)日：2023-05-30
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 , Cyrus Soli Poonawalla , Adar Cyrus Poonawalla
CPC分类号： A61K39/12 , C12N7/06 , A61K2039/5254 , A61K2039/55505 , A61K2039/55561 , A61K2039/55566 , A61K2039/55572 , A61K2039/55577 , A61K2039/55583 , C12N2770/24134
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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公开(公告)号：US20230183765A1
公开(公告)日：2023-06-15
申请号：US17924405
申请日：2021-05-13
摘要： 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.
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3.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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4.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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