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1. 发明专利

TW201919690A 具有改善之安定性、增強之免疫原性及降低之反應原性的免疫原性組成物和其製備方法审中-公开
简体标题：具有改善之安定性、增强之免疫原性及降低之反应原性的免疫原性组成物和其制备方法
公开(公告)号：TW201919690A
公开(公告)日：2019-06-01
申请号：TW107124600
申请日：2018-07-17
申请人：印度商印度血清研究公司 , SERUM INSTITUTE OF INDIA PRIVATE LIMITED
发明人：庫瑪拉凱許 , KUMAR, RAKESH , 夏瑪英德吉 , SHARMA, INDER JIT , 楊卡翠西陀樂 , VYANKATRAO, SHITOLE ANIL , 曼諾哈多達帕 , MANOHAR, DODDAPANENI , 夏瑪希特尤提 , SHARMA, HITT JYOTI
IPC分类号： A61K39/05 , A61K39/08 , A61K39/10 , A61K39/102 , A61K39/13 , A61K39/23 , A61K47/02 , A61K47/10 , A61K47/24 , A61K9/08
摘要：一種免疫原性組成物，其包含白喉類毒素(Diphtheriatoxoid)(D)抗原、破傷風類毒素(tetanustoxoid)(T)抗原、B型肝炎表面抗原(HBsAg)、去活化之全細胞百日咳博德特氏菌(B. pertussis)(wP)抗原、與載體蛋白軛合之B型流感嗜血桿菌(Haemophilus influenzaetype B)(Hib)莢膜糖、去活化之脊髓灰質炎(Polio)病毒(IPV)抗原和另外之一或多種抗原，及製備彼之方法。一種全液體組合疫苗，其顯示改善之免疫原性、降低之反應原性及改善之安定性。改善之甲醛去活化方法、個別吸附在磷酸鋁佐劑上之白喉類毒素(D)抗原、破傷風類毒素(T)抗原和B型肝炎(HepB)表面抗原之改善的吸附輪廓、最小總鋁含量(Al3+)和作為防腐劑之2-苯氧基乙醇(2-PE)的優化濃度。
简体摘要：一种免疫原性组成物，其包含白喉类毒素(Diphtheriatoxoid)(D)抗原、破伤风类毒素(tetanustoxoid)(T)抗原、B型肝炎表面抗原(HBsAg)、去活化之全细胞百日咳博德特氏菌(B. pertussis)(wP)抗原、与载体蛋白轭合之B型流感嗜血杆菌(Haemophilus influenzaetype B)(Hib)荚膜糖、去活化之嵴髓灰质炎(Polio)病毒(IPV)抗原和另外之一或多种抗原，及制备彼之方法。一种全液体组合疫苗，其显示改善之免疫原性、降低之反应原性及改善之安定性。改善之甲醛去活化方法、个别吸附在磷酸铝佐剂上之白喉类毒素(D)抗原、破伤风类毒素(T)抗原和B型肝炎(HepB)表面抗原之改善的吸附轮廓、最小总铝含量(Al3+)和作为防腐剂之2-苯氧基乙醇(2-PE)的优化浓度。

2. 发明申请

WO2021229604A1 METHODS FOR SIMULTANEOUS FRAGMENTATION AND PURIFICATION OF BACTERIAL POLYSACCHARIDES 审中-公开
公开(公告)号：WO2021229604A1
公开(公告)日：2021-11-18
申请号：PCT/IN2021/050455
申请日：2021-05-13
申请人： SERUM INSTITUTE OF INDIA PRIVATE LIMITED
发明人： DHERE, Rajeev Mhalasakant , JANA, Swapan Kumar , GAIKWAD, Walmik Karbhari
IPC分类号： C12P19/04 , A61K39/02 , A61P31/04 , C07H1/00
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.

3. 发明申请

WO2016063291A1 IMPROVED METHODS FOR ENTEROVIRUS INACTIVATION, ADJUVANT ADSORPTION AND DOSE REDUCED VACCINE COMPOSITIONS OBTAINED THEREOF 审中-公开
标题翻译：肠毒素灭活的改善方法，辅助吸收和剂量减少的其中得到的疫苗组合物
公开(公告)号：WO2016063291A1
公开(公告)日：2016-04-28
申请号：PCT/IN2015/000376
申请日：2015-10-06
申请人： SERUM INSTITUTE OF INDIA PRIVATE LIMITED
发明人： DHERE, Rajeev Mhalasakant , PISAL, Sambhaji Shankar , ZADE, Jagdish Kamalaji , SABALE, Rajendra Narayan
IPC分类号： C12N7/04 , C12N7/06 , A61K39/13 , A61K39/39
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.
摘要翻译：本发明涉及在氨基丁糖缓冲液存在下由甲醛引起的肠病毒灭活的改进方法，导致D-抗原的最大回收。随后将所述sIPV吸附在氢氧化铝上提供显着剂量降低的sIPV组合物。

4. 发明申请

WO2018122183A1 IMMUNOGENIC COMPOSITION COMPRISING CYAA-DERIVED POLYPEPTIDE PROMOTING A TH1/TH17-ORIENTED IMMUNE RESPONSE 审中-公开
公开(公告)号：WO2018122183A1
公开(公告)日：2018-07-05
申请号：PCT/EP2017/084449
申请日：2017-12-22
申请人： GENKYOTEX , SERUM INSTITUTE OF INDIA PRIVATE LIMITED
发明人： PALMANTIER, Rémi , MISSERI, Yolande , DIVEU-SADER, Caroline , GAIROLA, Sunil , GAUTAM, Manish , RAO, Harish , SHALIGRAM, Umesh
IPC分类号： A61K39/00 , A61K39/02 , A61K39/10
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.

5. 发明申请

WO2018116198A1 IMPROVED METHODS FOR ENHANCING ANTIBODY PRODUCTIVITY IN MAMMALIAN CELL CULTURE AND MINIMIZING AGGREGATION DURING DOWNSTREAM, FORMULATION PROCESSES AND STABLE ANTIBODY FORMULATIONS OBTAINED THEREOF 审中-公开
公开(公告)号：WO2018116198A1
公开(公告)日：2018-06-28
申请号：PCT/IB2017/058194
申请日：2017-12-20
申请人： SERUM INSTITUTE OF INDIA PRIVATE LIMITED
发明人： MHALASAKANT, Dhere Rajeev , SHANKAR, Pisal Sambhaji , REDDY, Peddi Reddy Srinivas , CHAHAR, Singh Digamber , RAVINDRA, Yeolekar Leena , SINGH, Chouhan Pankaj , DATTATRAY, Avalaskar Nikhil
IPC分类号： C07K16/00 , C07K16/10 , A61K39/395
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 lgG1 monoclonal antibody specific to the Dengue virus epitope in domain III of the E protein and lgG1 monoclonal antibody specific to the rabies virus surface G glycoprotein.

6. 发明申请

WO2018037365A8 MULTIVALENT VACCINE COMPOSITION 审中-公开
公开(公告)号：WO2018037365A8
公开(公告)日：2018-03-01
申请号：PCT/IB2017/055100
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： DHERE, Rajeev Mhalasakant , PISAL, Sambhaji Shankar , ZADE, Jagdish Kamalaji , SABALE, Rajendra Narayan , KADAM, Ravindra Bapurao , KAMBLE, Abhijeet Sanjeev , JIANG, Baoming , GLASS, Roger
IPC分类号： A61K39/12
摘要： The present invention relates to 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. The invention particularly provides a multivalent combination vaccine comprising of i) significantly dose reduced Salk IPV or Sabin IPV (IPV) antigens prepared by utilizing improved methods of formaldehyde inactivation and alum hydroxide adsorption resulting in maximum recovery of D-antigen and ii) Injectable heat inactivated Rotavirus antigen(s) obtained from Rotavirus (CDC-9) strains that provides a broad cross-protective immunity among human rotavirus strains, iii) Hib PRP -carrier protein conjugate having improved stability and immunogenicity wherein said Hib PRP -earner protein conjugate is initially prepared by using novel conjugation process and subsequently blended at low temperature in presence of a stabilizer for minimizing free PRP release iv) whole ceil pertussis antigen with improved immunogenicity and stability obtained by addition of whole cell pertussis antigen at a later stage in a blend thereby minimizing hydrolysis based degradation v) Homogenous fractions of Diphtheria toxoid and Tetanus toxoid obtained by removal of undesirable aggregates by using Gel Permeation chromatography. The process of making such stable and immunogenic vaccine compositions 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, on a combination of Alum hydroxide and Alum phosphate and ii) using a particular order of addition of antigens during blending is also disclosed.

7. 发明申请

WO2018037365A1 MULTIVALENT VACCINE COMPOSITION 审中-公开
标题翻译：多价疫苗组合物
公开(公告)号：WO2018037365A1
公开(公告)日：2018-03-01
申请号：PCT/IB2017/055100
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： DHERE, Rajeev Mhalasakant , PISAL, Sambhaji Shankar , ZADE, Jagdish Kamalaji , SABALE, Rajendra Narayan , KADAM, Ravindra Bapurao , KAMBLE, Abhijeet Sanjeev , JIANG, Baoming , GLASS, Roger
IPC分类号： A61K39/12
摘要： The present invention relates to stable, immunogenic combination vaccme(s) comprising a mixture of antigens for prevention and prophylaxis of infections caused by Rotavirus, Poliomyelitis virus, Haemophilus influenzae, Corynebacterium diphtheriae, Clostridium letani, Bordetel!a pertussis and Hepatitis B virus. The invention particularly provides a multivalent combination vaccine comprising of i) significantly dose reduced Salk IPV or Sabin IPV (IPV) antigens prepared by utilizing improved methods of formaldehyde inactivation and alum hydroxide adsorption resulting in maximum recovery of D-antigen and ii) Injectable heat inactivated Rotavirus antigen(s) obtained from Rotavirus (CDC-9) strains that provides a broad cross-protective immunity among human rotavirus strains, iii) Hib PRP -carrier protein conjugate having improved stability and immunogenicity wherein said Hib PRP -earner protein conjugate is initially prepared by using novel conjugation process and subsequently blended at low temperature in presence of a stabilizer for minimizing free PRP release iv) whole ceil pertussis antigen with improved immunogenicity and stability obtained by addition of whole cell pertussis antigen at a later stage in a blend thereby minimizing hydrolysis based degradation v) Homogenous fractions of Diphtheria toxoid and Tetanus toxoid obtained by removal of undesirable aggregates by using Gel Permeation chromatography.The process of making such stable and immunogenic vaccine compositions 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, on a combination of Alum hydroxide and Alum phosphate and ii) using a particular order of addition of antigens during blending is also disclosed.
摘要翻译：本发明涉及稳定的免疫原性组合疫苗（一种或多种），其包含抗原混合物，用于预防和预防由轮状病毒，脊髓灰质炎病毒，流感嗜血杆菌，白喉棒状杆菌，梭状芽胞杆菌，博德特尔，百日咳和乙型肝炎病毒。本发明特别提供了一种多价组合疫苗，其包含：i）通过利用改进的甲醛失活和氢氧化铝吸附方法制备的显着剂量减少的Salk IPV或Sabin IPV（IPV）抗原，导致D-抗原的最大回收率和ii）注射热灭活提供在人轮状病毒株中提供广泛的交叉保护性免疫的轮状病毒（CDC-9）株的轮状病毒抗原，iii）具有改善的稳定性和免疫原性的Hib PRP-载体蛋白缀合物，其中所述HibPRP-解读者蛋白缀合物最初通过使用新的缀合方法制备，并随后在稳定剂存在下在低温下共混以最小化释放的PRP释放iv）全细胞百日咳抗原，其通过在共混物的后期添加全细胞百日咳抗原而获得改进的免疫原性和稳定性，从而最小化基于水解的降解v）Diphthe的均质级分通过使用凝胶渗透色谱除去不合需要的聚集体而获得的类毒素和破伤风类毒素。通过i）单独吸附剂量减少的IPV来制备这种稳定和免疫原性疫苗组合物的方法。还揭示了氢氧化铝上的IRV抗原和保持其它抗原未吸附或吸附在磷酸铝，氢氧化铝上，氢氧化铝和磷酸铝的组合上，和ii）在共混过程中使用特定添加抗原的顺序。 p>

8. 发明申请

WO2021183533A1 ACTIVE BOOSTER IMMUNIZATION AGAINST TETANUS, DIPHTHERIA AND PERTUSSIS 审中-公开
公开(公告)号：WO2021183533A1
公开(公告)日：2021-09-16
申请号：PCT/US2021/021532
申请日：2021-03-09
申请人： DYNAVAX TECHNOLOGIES CORPORATION , SERUM INSTITUTE OF INDIA PRIVATE LIMITED
发明人： CAMPBELL, John D. , COFFMAN, Robert L. , HYER, Randall N. , JANSSEN, Robert S. , NOVACK, David , GOHLKE, Martin , URBAN, Maureen , GAIROLA, Sunil , SHALIGRAM, Umesh , GAUTUM, Manish , RAO, Harish
IPC分类号： A61K39/00 , A61P37/04 , C12N15/113 , C12N15/117
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.

9. 发明申请

WO2021044436A2 IMMUNOGENIC COMPOSITIONS AGAINST ENTERIC DISEASES AND METHODS FOR ITS PREPARATION THEREOF 审中-公开
公开(公告)号：WO2021044436A2
公开(公告)日：2021-03-11
申请号：PCT/IN2020/050763
申请日：2020-09-02
申请人： SERUM INSTITUTE OF INDIA PRIVATE LIMITED
发明人： DHERE, Rajeev Mhalasakant , PISAL, Sambhaji Shankar , ANNAMRAJU, Dattatreya Sarma , AVALASKAR, Nikhil Dattatray , HUNDEKARI, Yogesh Tukaram , TAKLIKAR, Anil Pirajirao , GOEL, Sunil Kumar , KAMAT, Chandrashekhar Dwarkanath , CHAVAN, Vishal Bharat
IPC分类号： A61K39/112 , A61P31/04 , A61K2039/6037 , A61K2039/70 , A61K39/0275
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.

10. 发明申请

WO2023037387A2 FREEZE-DRIED VIRAL COMBINATION VACCINE COMPOSITIONS AND PROCESS FOR PREPARATION THEREOF 审中-公开
公开(公告)号：WO2023037387A2
公开(公告)日：2023-03-16
申请号：PCT/IN2022/050805
申请日：2022-09-08
申请人： SERUM INSTITUTE OF INDIA PRIVATE LIMITED , CODAGENIX INC.
发明人： DHERE, Rajeev Mhalasakant , YEOLEKAR, Leena Ravindra , MEHLA, Rajeev , COLEMAN, John Robert
IPC分类号： A61K39/12 , A61K9/19 , A61K47/18 , A61K47/26 , A61K47/42 , A61K2039/5254 , A61K2039/543 , A61K2039/70 , A61K47/183 , A61K9/0019 , C12N2760/18434 , C12N2770/20034 , C12N2770/36234
摘要： : FREEZE-DRIED VIRAL COMBINATION VACCINE COMPOSITIONS AND PROCESS FOR PREPARATION THEREOF The present disclosure relates to field of lyophilized/freeze-dried viral combination composition/formulation and methods for manufacturing and obtaining the composition comprising at least three live attenuated virus selected from a group of Coronavirus, Measles virus and Rubella virus; and stabilizers comprising of at least one carbohydrate, at least one amino acid and at least one hydrolyzed protein. The said lyophilized/freeze-dried viral combination composition/formulation is a vaccine composition that preserves the desired characteristics of each virus, including stability and immunogenicity. The composition can be safely administered subcutaneously as a combination vaccine composition such that the immunogenicity of each of the measles, rubella and SARS-CoV-2 is not inferior to that observed for each of the three viruses when administered as individual vaccines and is found to be equivalent or improved as compared to immunogenicity of SARS-CoV-2 vaccine given intranasally. The purification process is devoid of chromatography steps.

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