Quantitation of novel pentavalent meningococcal polysaccharide conjugate vaccine (Men A-TT, Men C-CRM, Men Y-CRM, Men W-CRM, Men X-TT) using sandwich ELISA
Meningococcal vaccines have been developed over the years, to control outbreaks of meningitis. There are 12 immunologically distinct serogroups of which, A, B, C, W, Y and X are predominant and invasive in nature. Meningococcal vaccines can be sorted out as, polysaccharide vaccines, polysaccharide p...
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| Veröffentlicht in: | Vaccine 2020-11, Vol.38 (49), p.7815-7824 |
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| creator | Phugare, Swapnil Kale, Sameer Sharma, Pankaj Kumar Goel, Sunil Gairola, Sunil Jadhav, Suresh S. |
| description | Meningococcal vaccines have been developed over the years, to control outbreaks of meningitis. There are 12 immunologically distinct serogroups of which, A, B, C, W, Y and X are predominant and invasive in nature. Meningococcal vaccines can be sorted out as, polysaccharide vaccines, polysaccharide protein conjugate vaccines or protein based (independent of polysaccharides) vaccines. Stringent quality control analysis as per the regulatory guidelines is a requirement for any vaccine manufacturer for commercial release of vaccines. Quantitation becomes challenging when it comes to analysis of multivalent vaccines. We describe the quantitation of novel pentavalent meningococcal polysaccharide conjugate vaccine manufactured at Serum Institute of India Pvt Ltd (SIIPL). Briefly, sandwich ELISA assay was developed to quantitate five different serogroups (Men A-TT, Men C-CRM, Men Y-CRM, Men W-CRM, Men X-TT) in pentavalent meningococcal polysaccharide conjugate vaccine containing two different carrier proteins (TT and CRM). ELISA reported herein showed significant reproducibility and repeatability over a range of developed standard curve with acceptable coefficient of variation ( |
| doi_str_mv | 10.1016/j.vaccine.2020.10.017 |
| format | Article |
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There are 12 immunologically distinct serogroups of which, A, B, C, W, Y and X are predominant and invasive in nature. Meningococcal vaccines can be sorted out as, polysaccharide vaccines, polysaccharide protein conjugate vaccines or protein based (independent of polysaccharides) vaccines. Stringent quality control analysis as per the regulatory guidelines is a requirement for any vaccine manufacturer for commercial release of vaccines. Quantitation becomes challenging when it comes to analysis of multivalent vaccines. We describe the quantitation of novel pentavalent meningococcal polysaccharide conjugate vaccine manufactured at Serum Institute of India Pvt Ltd (SIIPL). Briefly, sandwich ELISA assay was developed to quantitate five different serogroups (Men A-TT, Men C-CRM, Men Y-CRM, Men W-CRM, Men X-TT) in pentavalent meningococcal polysaccharide conjugate vaccine containing two different carrier proteins (TT and CRM). ELISA reported herein showed significant reproducibility and repeatability over a range of developed standard curve with acceptable coefficient of variation (<15%) for both intra and inter assay. Furthermore analysis showed that, polysaccharide conjugate (PC) contents were within the accepted range (±30%) of the stated label claim. The immunoassay was verified for its sensitivity, accuracy and precision. Based on the relevant experimental data; it is proposed that, reported sandwich ELISA is well suited for quantitation of individual polysaccharide conjugate from pentavalent formulation. Furthermore, the ELISA was explored for forced degradation and polysaccharide spiking studies. This leads to open up an area of research for sandwich ELISA as a tool to assess the integrity of vaccine as well as for lot to lot consistency monitoring.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2020.10.017</identifier><identifier>PMID: 33164804</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Acids ; Antibodies ; Antibodies, Bacterial ; Antigens ; Coefficient of variation ; Conjugates ; CRM ; ELISA ; Enzyme-Linked Immunosorbent Assay ; Humans ; Immunoassay ; India ; Male ; Meningitis ; Meningococcal Infections ; Meningococcal serogroup X ; Meningococcal Vaccines ; Polysaccharides ; Potassium ; Proteins ; Quality control ; Quantitation ; Reproducibility ; Reproducibility of Results ; Saccharides ; Vaccines ; Vaccines, Combined ; Vaccines, Conjugate</subject><ispartof>Vaccine, 2020-11, Vol.38 (49), p.7815-7824</ispartof><rights>2020 Elsevier Ltd</rights><rights>Copyright © 2020 Elsevier Ltd. 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Elsevier Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-d0df429d31cffa61a175c655dd6e7d5c17b5984cbe72be83b89b21cb714c2c193</citedby><cites>FETCH-LOGICAL-c393t-d0df429d31cffa61a175c655dd6e7d5c17b5984cbe72be83b89b21cb714c2c193</cites><orcidid>0000-0003-4093-9736</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2457584358?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976,64364,64366,64368,72218</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33164804$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Phugare, Swapnil</creatorcontrib><creatorcontrib>Kale, Sameer</creatorcontrib><creatorcontrib>Sharma, Pankaj</creatorcontrib><creatorcontrib>Kumar Goel, Sunil</creatorcontrib><creatorcontrib>Gairola, Sunil</creatorcontrib><creatorcontrib>Jadhav, Suresh S.</creatorcontrib><title>Quantitation of novel pentavalent meningococcal polysaccharide conjugate vaccine (Men A-TT, Men C-CRM, Men Y-CRM, Men W-CRM, Men X-TT) using sandwich ELISA</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Meningococcal vaccines have been developed over the years, to control outbreaks of meningitis. There are 12 immunologically distinct serogroups of which, A, B, C, W, Y and X are predominant and invasive in nature. Meningococcal vaccines can be sorted out as, polysaccharide vaccines, polysaccharide protein conjugate vaccines or protein based (independent of polysaccharides) vaccines. Stringent quality control analysis as per the regulatory guidelines is a requirement for any vaccine manufacturer for commercial release of vaccines. Quantitation becomes challenging when it comes to analysis of multivalent vaccines. We describe the quantitation of novel pentavalent meningococcal polysaccharide conjugate vaccine manufactured at Serum Institute of India Pvt Ltd (SIIPL). Briefly, sandwich ELISA assay was developed to quantitate five different serogroups (Men A-TT, Men C-CRM, Men Y-CRM, Men W-CRM, Men X-TT) in pentavalent meningococcal polysaccharide conjugate vaccine containing two different carrier proteins (TT and CRM). ELISA reported herein showed significant reproducibility and repeatability over a range of developed standard curve with acceptable coefficient of variation (<15%) for both intra and inter assay. Furthermore analysis showed that, polysaccharide conjugate (PC) contents were within the accepted range (±30%) of the stated label claim. The immunoassay was verified for its sensitivity, accuracy and precision. Based on the relevant experimental data; it is proposed that, reported sandwich ELISA is well suited for quantitation of individual polysaccharide conjugate from pentavalent formulation. Furthermore, the ELISA was explored for forced degradation and polysaccharide spiking studies. This leads to open up an area of research for sandwich ELISA as a tool to assess the integrity of vaccine as well as for lot to lot consistency monitoring.</description><subject>Acids</subject><subject>Antibodies</subject><subject>Antibodies, Bacterial</subject><subject>Antigens</subject><subject>Coefficient of variation</subject><subject>Conjugates</subject><subject>CRM</subject><subject>ELISA</subject><subject>Enzyme-Linked Immunosorbent Assay</subject><subject>Humans</subject><subject>Immunoassay</subject><subject>India</subject><subject>Male</subject><subject>Meningitis</subject><subject>Meningococcal Infections</subject><subject>Meningococcal serogroup X</subject><subject>Meningococcal Vaccines</subject><subject>Polysaccharides</subject><subject>Potassium</subject><subject>Proteins</subject><subject>Quality control</subject><subject>Quantitation</subject><subject>Reproducibility</subject><subject>Reproducibility of 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There are 12 immunologically distinct serogroups of which, A, B, C, W, Y and X are predominant and invasive in nature. Meningococcal vaccines can be sorted out as, polysaccharide vaccines, polysaccharide protein conjugate vaccines or protein based (independent of polysaccharides) vaccines. Stringent quality control analysis as per the regulatory guidelines is a requirement for any vaccine manufacturer for commercial release of vaccines. Quantitation becomes challenging when it comes to analysis of multivalent vaccines. We describe the quantitation of novel pentavalent meningococcal polysaccharide conjugate vaccine manufactured at Serum Institute of India Pvt Ltd (SIIPL). Briefly, sandwich ELISA assay was developed to quantitate five different serogroups (Men A-TT, Men C-CRM, Men Y-CRM, Men W-CRM, Men X-TT) in pentavalent meningococcal polysaccharide conjugate vaccine containing two different carrier proteins (TT and CRM). ELISA reported herein showed significant reproducibility and repeatability over a range of developed standard curve with acceptable coefficient of variation (<15%) for both intra and inter assay. Furthermore analysis showed that, polysaccharide conjugate (PC) contents were within the accepted range (±30%) of the stated label claim. The immunoassay was verified for its sensitivity, accuracy and precision. Based on the relevant experimental data; it is proposed that, reported sandwich ELISA is well suited for quantitation of individual polysaccharide conjugate from pentavalent formulation. Furthermore, the ELISA was explored for forced degradation and polysaccharide spiking studies. This leads to open up an area of research for sandwich ELISA as a tool to assess the integrity of vaccine as well as for lot to lot consistency monitoring.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>33164804</pmid><doi>10.1016/j.vaccine.2020.10.017</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-4093-9736</orcidid></addata></record> |
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| subjects | Acids Antibodies Antibodies, Bacterial Antigens Coefficient of variation Conjugates CRM ELISA Enzyme-Linked Immunosorbent Assay Humans Immunoassay India Male Meningitis Meningococcal Infections Meningococcal serogroup X Meningococcal Vaccines Polysaccharides Potassium Proteins Quality control Quantitation Reproducibility Reproducibility of Results Saccharides Vaccines Vaccines, Combined Vaccines, Conjugate |
| title | Quantitation of novel pentavalent meningococcal polysaccharide conjugate vaccine (Men A-TT, Men C-CRM, Men Y-CRM, Men W-CRM, Men X-TT) using sandwich ELISA |
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