Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein subunit vaccine is one of the mainstream technology platforms for the development of COVID-19 vaccines, and most R&D units use the receptor-binding domain (RBD) or spike (S) protein as the main target antigen. The complexit...
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Autor*in:	Lu Han [verfasserIn] Chaoqiang An [verfasserIn] Dong Liu [verfasserIn] Zejun Wang [verfasserIn] Lianlian Bian [verfasserIn] Qian He [verfasserIn] Jianyang Liu [verfasserIn] Qian Wang [verfasserIn] Mingchen Liu [verfasserIn] Qunying Mao [verfasserIn] Taijun Hang [verfasserIn] Aiping Wang [verfasserIn] Fan Gao [verfasserIn] Dejiang Tan [verfasserIn] Zhenglun Liang [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 coronavirus disease protein subunit vaccine antigen content analytical quality by design (AQbD)

Übergeordnetes Werk:	In: Viruses - MDPI AG, 2009, 15(2022), 1, p 62
Übergeordnetes Werk:	volume:15 ; year:2022 ; number:1, p 62

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.3390/v15010062

Katalog-ID:	DOAJ081686366

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allfields	10.3390/v15010062 doi (DE-627)DOAJ081686366 (DE-599)DOAJ3e66eceb0a9a4c95a2ab4c9cf21e961e DE-627 ger DE-627 rakwb eng QR1-502 Lu Han verfasserin aut Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein subunit vaccine is one of the mainstream technology platforms for the development of COVID-19 vaccines, and most R&D units use the receptor-binding domain (RBD) or spike (S) protein as the main target antigen. The complexity of vaccine design, sequence, and expression systems makes it urgent to establish common antigen assays to facilitate vaccine development. In this study, we report the development of a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to determine the antigen content of SARS-CoV-2 protein subunit vaccines based on the United States Pharmacopeia <1220< and ICH (international conference on harmonization) Q14 and Q2 (R2) requirements. A monoclonal antibody (mAb), 20D8, was identified as the detection antibody based on its high RBD binding activity (EC50 = 8.4 ng/mL), broad-spectrum anti-variant neutralizing activity (EC50: 2.7–9.8 ng/mL for pseudovirus and EC50: 9.6–127 ng/mL for authentic virus), good in vivo protection, and a recognized linear RBD epitope (369–379 aa). A porcine anti-RBD polyclonal antibody was selected as the coating antibody. Assay performance met the requirements of the analytical target profile with an accuracy and precision of ≥90% and adequate specificity. Within the specification range of 70–143%, the method capability index was <0.96; the misjudgment probability was <0.39%. The method successfully detected SARS-CoV-2 protein subunit vaccine antigens (RBD or S protein sequences in Alpha, Beta, Gamma, or Delta variants) obtained from five different manufacturers. Thus, we present a new robust, reliable, and general method for measuring the antigenic content of SARS-CoV-2 protein subunit vaccines. In addition to currently marketed and emergency vaccines, it is suitable for vaccines in development containing antigens derived from pre-Omicron mutant strains. severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 coronavirus disease protein subunit vaccine antigen content analytical quality by design (AQbD) Microbiology Chaoqiang An verfasserin aut Dong Liu verfasserin aut Zejun Wang verfasserin aut Lianlian Bian verfasserin aut Qian He verfasserin aut Jianyang Liu verfasserin aut Qian Wang verfasserin aut Mingchen Liu verfasserin aut Qunying Mao verfasserin aut Taijun Hang verfasserin aut Aiping Wang verfasserin aut Fan Gao verfasserin aut Dejiang Tan verfasserin aut Zhenglun Liang verfasserin aut In Viruses MDPI AG, 2009 15(2022), 1, p 62 (DE-627)609775871 (DE-600)2516098-9 19994915 nnns volume:15 year:2022 number:1, p 62 https://doi.org/10.3390/v15010062 kostenfrei https://doaj.org/article/3e66eceb0a9a4c95a2ab4c9cf21e961e kostenfrei https://www.mdpi.com/1999-4915/15/1/62 kostenfrei https://doaj.org/toc/1999-4915 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 15 2022 1, p 62
spelling	10.3390/v15010062 doi (DE-627)DOAJ081686366 (DE-599)DOAJ3e66eceb0a9a4c95a2ab4c9cf21e961e DE-627 ger DE-627 rakwb eng QR1-502 Lu Han verfasserin aut Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein subunit vaccine is one of the mainstream technology platforms for the development of COVID-19 vaccines, and most R&D units use the receptor-binding domain (RBD) or spike (S) protein as the main target antigen. The complexity of vaccine design, sequence, and expression systems makes it urgent to establish common antigen assays to facilitate vaccine development. In this study, we report the development of a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to determine the antigen content of SARS-CoV-2 protein subunit vaccines based on the United States Pharmacopeia <1220< and ICH (international conference on harmonization) Q14 and Q2 (R2) requirements. A monoclonal antibody (mAb), 20D8, was identified as the detection antibody based on its high RBD binding activity (EC50 = 8.4 ng/mL), broad-spectrum anti-variant neutralizing activity (EC50: 2.7–9.8 ng/mL for pseudovirus and EC50: 9.6–127 ng/mL for authentic virus), good in vivo protection, and a recognized linear RBD epitope (369–379 aa). A porcine anti-RBD polyclonal antibody was selected as the coating antibody. Assay performance met the requirements of the analytical target profile with an accuracy and precision of ≥90% and adequate specificity. Within the specification range of 70–143%, the method capability index was <0.96; the misjudgment probability was <0.39%. The method successfully detected SARS-CoV-2 protein subunit vaccine antigens (RBD or S protein sequences in Alpha, Beta, Gamma, or Delta variants) obtained from five different manufacturers. Thus, we present a new robust, reliable, and general method for measuring the antigenic content of SARS-CoV-2 protein subunit vaccines. In addition to currently marketed and emergency vaccines, it is suitable for vaccines in development containing antigens derived from pre-Omicron mutant strains. severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 coronavirus disease protein subunit vaccine antigen content analytical quality by design (AQbD) Microbiology Chaoqiang An verfasserin aut Dong Liu verfasserin aut Zejun Wang verfasserin aut Lianlian Bian verfasserin aut Qian He verfasserin aut Jianyang Liu verfasserin aut Qian Wang verfasserin aut Mingchen Liu verfasserin aut Qunying Mao verfasserin aut Taijun Hang verfasserin aut Aiping Wang verfasserin aut Fan Gao verfasserin aut Dejiang Tan verfasserin aut Zhenglun Liang verfasserin aut In Viruses MDPI AG, 2009 15(2022), 1, p 62 (DE-627)609775871 (DE-600)2516098-9 19994915 nnns volume:15 year:2022 number:1, p 62 https://doi.org/10.3390/v15010062 kostenfrei https://doaj.org/article/3e66eceb0a9a4c95a2ab4c9cf21e961e kostenfrei https://www.mdpi.com/1999-4915/15/1/62 kostenfrei https://doaj.org/toc/1999-4915 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 15 2022 1, p 62
allfields_unstemmed	10.3390/v15010062 doi (DE-627)DOAJ081686366 (DE-599)DOAJ3e66eceb0a9a4c95a2ab4c9cf21e961e DE-627 ger DE-627 rakwb eng QR1-502 Lu Han verfasserin aut Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein subunit vaccine is one of the mainstream technology platforms for the development of COVID-19 vaccines, and most R&D units use the receptor-binding domain (RBD) or spike (S) protein as the main target antigen. The complexity of vaccine design, sequence, and expression systems makes it urgent to establish common antigen assays to facilitate vaccine development. In this study, we report the development of a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to determine the antigen content of SARS-CoV-2 protein subunit vaccines based on the United States Pharmacopeia <1220< and ICH (international conference on harmonization) Q14 and Q2 (R2) requirements. A monoclonal antibody (mAb), 20D8, was identified as the detection antibody based on its high RBD binding activity (EC50 = 8.4 ng/mL), broad-spectrum anti-variant neutralizing activity (EC50: 2.7–9.8 ng/mL for pseudovirus and EC50: 9.6–127 ng/mL for authentic virus), good in vivo protection, and a recognized linear RBD epitope (369–379 aa). A porcine anti-RBD polyclonal antibody was selected as the coating antibody. Assay performance met the requirements of the analytical target profile with an accuracy and precision of ≥90% and adequate specificity. Within the specification range of 70–143%, the method capability index was <0.96; the misjudgment probability was <0.39%. The method successfully detected SARS-CoV-2 protein subunit vaccine antigens (RBD or S protein sequences in Alpha, Beta, Gamma, or Delta variants) obtained from five different manufacturers. Thus, we present a new robust, reliable, and general method for measuring the antigenic content of SARS-CoV-2 protein subunit vaccines. In addition to currently marketed and emergency vaccines, it is suitable for vaccines in development containing antigens derived from pre-Omicron mutant strains. severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 coronavirus disease protein subunit vaccine antigen content analytical quality by design (AQbD) Microbiology Chaoqiang An verfasserin aut Dong Liu verfasserin aut Zejun Wang verfasserin aut Lianlian Bian verfasserin aut Qian He verfasserin aut Jianyang Liu verfasserin aut Qian Wang verfasserin aut Mingchen Liu verfasserin aut Qunying Mao verfasserin aut Taijun Hang verfasserin aut Aiping Wang verfasserin aut Fan Gao verfasserin aut Dejiang Tan verfasserin aut Zhenglun Liang verfasserin aut In Viruses MDPI AG, 2009 15(2022), 1, p 62 (DE-627)609775871 (DE-600)2516098-9 19994915 nnns volume:15 year:2022 number:1, p 62 https://doi.org/10.3390/v15010062 kostenfrei https://doaj.org/article/3e66eceb0a9a4c95a2ab4c9cf21e961e kostenfrei https://www.mdpi.com/1999-4915/15/1/62 kostenfrei https://doaj.org/toc/1999-4915 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 15 2022 1, p 62
allfieldsGer	10.3390/v15010062 doi (DE-627)DOAJ081686366 (DE-599)DOAJ3e66eceb0a9a4c95a2ab4c9cf21e961e DE-627 ger DE-627 rakwb eng QR1-502 Lu Han verfasserin aut Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein subunit vaccine is one of the mainstream technology platforms for the development of COVID-19 vaccines, and most R&D units use the receptor-binding domain (RBD) or spike (S) protein as the main target antigen. The complexity of vaccine design, sequence, and expression systems makes it urgent to establish common antigen assays to facilitate vaccine development. In this study, we report the development of a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to determine the antigen content of SARS-CoV-2 protein subunit vaccines based on the United States Pharmacopeia <1220< and ICH (international conference on harmonization) Q14 and Q2 (R2) requirements. A monoclonal antibody (mAb), 20D8, was identified as the detection antibody based on its high RBD binding activity (EC50 = 8.4 ng/mL), broad-spectrum anti-variant neutralizing activity (EC50: 2.7–9.8 ng/mL for pseudovirus and EC50: 9.6–127 ng/mL for authentic virus), good in vivo protection, and a recognized linear RBD epitope (369–379 aa). A porcine anti-RBD polyclonal antibody was selected as the coating antibody. Assay performance met the requirements of the analytical target profile with an accuracy and precision of ≥90% and adequate specificity. Within the specification range of 70–143%, the method capability index was <0.96; the misjudgment probability was <0.39%. The method successfully detected SARS-CoV-2 protein subunit vaccine antigens (RBD or S protein sequences in Alpha, Beta, Gamma, or Delta variants) obtained from five different manufacturers. Thus, we present a new robust, reliable, and general method for measuring the antigenic content of SARS-CoV-2 protein subunit vaccines. In addition to currently marketed and emergency vaccines, it is suitable for vaccines in development containing antigens derived from pre-Omicron mutant strains. severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 coronavirus disease protein subunit vaccine antigen content analytical quality by design (AQbD) Microbiology Chaoqiang An verfasserin aut Dong Liu verfasserin aut Zejun Wang verfasserin aut Lianlian Bian verfasserin aut Qian He verfasserin aut Jianyang Liu verfasserin aut Qian Wang verfasserin aut Mingchen Liu verfasserin aut Qunying Mao verfasserin aut Taijun Hang verfasserin aut Aiping Wang verfasserin aut Fan Gao verfasserin aut Dejiang Tan verfasserin aut Zhenglun Liang verfasserin aut In Viruses MDPI AG, 2009 15(2022), 1, p 62 (DE-627)609775871 (DE-600)2516098-9 19994915 nnns volume:15 year:2022 number:1, p 62 https://doi.org/10.3390/v15010062 kostenfrei https://doaj.org/article/3e66eceb0a9a4c95a2ab4c9cf21e961e kostenfrei https://www.mdpi.com/1999-4915/15/1/62 kostenfrei https://doaj.org/toc/1999-4915 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 15 2022 1, p 62
allfieldsSound	10.3390/v15010062 doi (DE-627)DOAJ081686366 (DE-599)DOAJ3e66eceb0a9a4c95a2ab4c9cf21e961e DE-627 ger DE-627 rakwb eng QR1-502 Lu Han verfasserin aut Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein subunit vaccine is one of the mainstream technology platforms for the development of COVID-19 vaccines, and most R&D units use the receptor-binding domain (RBD) or spike (S) protein as the main target antigen. The complexity of vaccine design, sequence, and expression systems makes it urgent to establish common antigen assays to facilitate vaccine development. In this study, we report the development of a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to determine the antigen content of SARS-CoV-2 protein subunit vaccines based on the United States Pharmacopeia <1220< and ICH (international conference on harmonization) Q14 and Q2 (R2) requirements. A monoclonal antibody (mAb), 20D8, was identified as the detection antibody based on its high RBD binding activity (EC50 = 8.4 ng/mL), broad-spectrum anti-variant neutralizing activity (EC50: 2.7–9.8 ng/mL for pseudovirus and EC50: 9.6–127 ng/mL for authentic virus), good in vivo protection, and a recognized linear RBD epitope (369–379 aa). A porcine anti-RBD polyclonal antibody was selected as the coating antibody. Assay performance met the requirements of the analytical target profile with an accuracy and precision of ≥90% and adequate specificity. Within the specification range of 70–143%, the method capability index was <0.96; the misjudgment probability was <0.39%. The method successfully detected SARS-CoV-2 protein subunit vaccine antigens (RBD or S protein sequences in Alpha, Beta, Gamma, or Delta variants) obtained from five different manufacturers. Thus, we present a new robust, reliable, and general method for measuring the antigenic content of SARS-CoV-2 protein subunit vaccines. In addition to currently marketed and emergency vaccines, it is suitable for vaccines in development containing antigens derived from pre-Omicron mutant strains. severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 coronavirus disease protein subunit vaccine antigen content analytical quality by design (AQbD) Microbiology Chaoqiang An verfasserin aut Dong Liu verfasserin aut Zejun Wang verfasserin aut Lianlian Bian verfasserin aut Qian He verfasserin aut Jianyang Liu verfasserin aut Qian Wang verfasserin aut Mingchen Liu verfasserin aut Qunying Mao verfasserin aut Taijun Hang verfasserin aut Aiping Wang verfasserin aut Fan Gao verfasserin aut Dejiang Tan verfasserin aut Zhenglun Liang verfasserin aut In Viruses MDPI AG, 2009 15(2022), 1, p 62 (DE-627)609775871 (DE-600)2516098-9 19994915 nnns volume:15 year:2022 number:1, p 62 https://doi.org/10.3390/v15010062 kostenfrei https://doaj.org/article/3e66eceb0a9a4c95a2ab4c9cf21e961e kostenfrei https://www.mdpi.com/1999-4915/15/1/62 kostenfrei https://doaj.org/toc/1999-4915 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 15 2022 1, p 62
language	English
source	In Viruses 15(2022), 1, p 62 volume:15 year:2022 number:1, p 62
sourceStr	In Viruses 15(2022), 1, p 62 volume:15 year:2022 number:1, p 62
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 coronavirus disease protein subunit vaccine antigen content analytical quality by design (AQbD) Microbiology
isfreeaccess_bool	true
container_title	Viruses
authorswithroles_txt_mv	Lu Han @@aut@@ Chaoqiang An @@aut@@ Dong Liu @@aut@@ Zejun Wang @@aut@@ Lianlian Bian @@aut@@ Qian He @@aut@@ Jianyang Liu @@aut@@ Qian Wang @@aut@@ Mingchen Liu @@aut@@ Qunying Mao @@aut@@ Taijun Hang @@aut@@ Aiping Wang @@aut@@ Fan Gao @@aut@@ Dejiang Tan @@aut@@ Zhenglun Liang @@aut@@
publishDateDaySort_date	2022-01-01T00:00:00Z
hierarchy_top_id	609775871
id	DOAJ081686366
language_de	englisch
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callnumber-first	Q - Science
author	Lu Han
spellingShingle	Lu Han misc QR1-502 misc severe acute respiratory syndrome coronavirus 2 misc SARS-CoV-2 misc coronavirus disease misc protein subunit vaccine misc antigen content misc analytical quality by design (AQbD) misc Microbiology Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content
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topic_title	QR1-502 Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 coronavirus disease protein subunit vaccine antigen content analytical quality by design (AQbD)
topic	misc QR1-502 misc severe acute respiratory syndrome coronavirus 2 misc SARS-CoV-2 misc coronavirus disease misc protein subunit vaccine misc antigen content misc analytical quality by design (AQbD) misc Microbiology
topic_unstemmed	misc QR1-502 misc severe acute respiratory syndrome coronavirus 2 misc SARS-CoV-2 misc coronavirus disease misc protein subunit vaccine misc antigen content misc analytical quality by design (AQbD) misc Microbiology
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title	Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content
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title_full	Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content
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author_browse	Lu Han Chaoqiang An Dong Liu Zejun Wang Lianlian Bian Qian He Jianyang Liu Qian Wang Mingchen Liu Qunying Mao Taijun Hang Aiping Wang Fan Gao Dejiang Tan Zhenglun Liang
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title_sort	development of an elisa assay for the determination of sars-cov-2 protein subunit vaccine antigen content
callnumber	QR1-502
title_auth	Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content
abstract	The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein subunit vaccine is one of the mainstream technology platforms for the development of COVID-19 vaccines, and most R&D units use the receptor-binding domain (RBD) or spike (S) protein as the main target antigen. The complexity of vaccine design, sequence, and expression systems makes it urgent to establish common antigen assays to facilitate vaccine development. In this study, we report the development of a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to determine the antigen content of SARS-CoV-2 protein subunit vaccines based on the United States Pharmacopeia <1220< and ICH (international conference on harmonization) Q14 and Q2 (R2) requirements. A monoclonal antibody (mAb), 20D8, was identified as the detection antibody based on its high RBD binding activity (EC50 = 8.4 ng/mL), broad-spectrum anti-variant neutralizing activity (EC50: 2.7–9.8 ng/mL for pseudovirus and EC50: 9.6–127 ng/mL for authentic virus), good in vivo protection, and a recognized linear RBD epitope (369–379 aa). A porcine anti-RBD polyclonal antibody was selected as the coating antibody. Assay performance met the requirements of the analytical target profile with an accuracy and precision of ≥90% and adequate specificity. Within the specification range of 70–143%, the method capability index was <0.96; the misjudgment probability was <0.39%. The method successfully detected SARS-CoV-2 protein subunit vaccine antigens (RBD or S protein sequences in Alpha, Beta, Gamma, or Delta variants) obtained from five different manufacturers. Thus, we present a new robust, reliable, and general method for measuring the antigenic content of SARS-CoV-2 protein subunit vaccines. In addition to currently marketed and emergency vaccines, it is suitable for vaccines in development containing antigens derived from pre-Omicron mutant strains.
abstractGer	The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein subunit vaccine is one of the mainstream technology platforms for the development of COVID-19 vaccines, and most R&D units use the receptor-binding domain (RBD) or spike (S) protein as the main target antigen. The complexity of vaccine design, sequence, and expression systems makes it urgent to establish common antigen assays to facilitate vaccine development. In this study, we report the development of a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to determine the antigen content of SARS-CoV-2 protein subunit vaccines based on the United States Pharmacopeia <1220< and ICH (international conference on harmonization) Q14 and Q2 (R2) requirements. A monoclonal antibody (mAb), 20D8, was identified as the detection antibody based on its high RBD binding activity (EC50 = 8.4 ng/mL), broad-spectrum anti-variant neutralizing activity (EC50: 2.7–9.8 ng/mL for pseudovirus and EC50: 9.6–127 ng/mL for authentic virus), good in vivo protection, and a recognized linear RBD epitope (369–379 aa). A porcine anti-RBD polyclonal antibody was selected as the coating antibody. Assay performance met the requirements of the analytical target profile with an accuracy and precision of ≥90% and adequate specificity. Within the specification range of 70–143%, the method capability index was <0.96; the misjudgment probability was <0.39%. The method successfully detected SARS-CoV-2 protein subunit vaccine antigens (RBD or S protein sequences in Alpha, Beta, Gamma, or Delta variants) obtained from five different manufacturers. Thus, we present a new robust, reliable, and general method for measuring the antigenic content of SARS-CoV-2 protein subunit vaccines. In addition to currently marketed and emergency vaccines, it is suitable for vaccines in development containing antigens derived from pre-Omicron mutant strains.
abstract_unstemmed	The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein subunit vaccine is one of the mainstream technology platforms for the development of COVID-19 vaccines, and most R&D units use the receptor-binding domain (RBD) or spike (S) protein as the main target antigen. The complexity of vaccine design, sequence, and expression systems makes it urgent to establish common antigen assays to facilitate vaccine development. In this study, we report the development of a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to determine the antigen content of SARS-CoV-2 protein subunit vaccines based on the United States Pharmacopeia <1220< and ICH (international conference on harmonization) Q14 and Q2 (R2) requirements. A monoclonal antibody (mAb), 20D8, was identified as the detection antibody based on its high RBD binding activity (EC50 = 8.4 ng/mL), broad-spectrum anti-variant neutralizing activity (EC50: 2.7–9.8 ng/mL for pseudovirus and EC50: 9.6–127 ng/mL for authentic virus), good in vivo protection, and a recognized linear RBD epitope (369–379 aa). A porcine anti-RBD polyclonal antibody was selected as the coating antibody. Assay performance met the requirements of the analytical target profile with an accuracy and precision of ≥90% and adequate specificity. Within the specification range of 70–143%, the method capability index was <0.96; the misjudgment probability was <0.39%. The method successfully detected SARS-CoV-2 protein subunit vaccine antigens (RBD or S protein sequences in Alpha, Beta, Gamma, or Delta variants) obtained from five different manufacturers. Thus, we present a new robust, reliable, and general method for measuring the antigenic content of SARS-CoV-2 protein subunit vaccines. In addition to currently marketed and emergency vaccines, it is suitable for vaccines in development containing antigens derived from pre-Omicron mutant strains.
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container_issue	1, p 62
title_short	Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content
url	https://doi.org/10.3390/v15010062 https://doaj.org/article/3e66eceb0a9a4c95a2ab4c9cf21e961e https://www.mdpi.com/1999-4915/15/1/62 https://doaj.org/toc/1999-4915
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Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

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