Débora Oliveira, Weslley Santos, I. Santos, Karolyne Ruibal, Lucas Silva
{"title":"应用于重组Covid-19疫苗活性药物成分生产的苯并酶®内切酶的鉴定、纯度和活性测定","authors":"Débora Oliveira, Weslley Santos, I. Santos, Karolyne Ruibal, Lucas Silva","doi":"10.35259/isi.2022_52256","DOIUrl":null,"url":null,"abstract":"gel was able to detect the presence of putative contaminant proteins in amounts as low as 0.6 μg. The enzymatic activity by UV-Visible method proved to be precise and robust for variations in the incubation time on ice and wavelength of reading. The validation of ICP-OES method for the elemental impurities complied with selectivity acceptance criteria and showed an acceptable sensibility degree. Conclusion: Our results providing sufficient evidences to demonstrate that all assays are suitable for its intended purpose. This multidisciplinary work is now part of the routine of analysis required before Benzonase® utilization in the production of the Recombinant Covid-19 Vaccine API by Bio-Manguinhos/Fiocruz.","PeriodicalId":8089,"journal":{"name":"Annals of the symposium: vaccines, biopharmaceuticals, in vitro diagnosis, management, other related themes","volume":"54 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Determining identity, purity and activity of Benzonase® endonuclease applied on the Recombinant Covid-19 Vaccine active pharmaceutical ingredient production\",\"authors\":\"Débora Oliveira, Weslley Santos, I. Santos, Karolyne Ruibal, Lucas Silva\",\"doi\":\"10.35259/isi.2022_52256\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"gel was able to detect the presence of putative contaminant proteins in amounts as low as 0.6 μg. The enzymatic activity by UV-Visible method proved to be precise and robust for variations in the incubation time on ice and wavelength of reading. The validation of ICP-OES method for the elemental impurities complied with selectivity acceptance criteria and showed an acceptable sensibility degree. Conclusion: Our results providing sufficient evidences to demonstrate that all assays are suitable for its intended purpose. This multidisciplinary work is now part of the routine of analysis required before Benzonase® utilization in the production of the Recombinant Covid-19 Vaccine API by Bio-Manguinhos/Fiocruz.\",\"PeriodicalId\":8089,\"journal\":{\"name\":\"Annals of the symposium: vaccines, biopharmaceuticals, in vitro diagnosis, management, other related themes\",\"volume\":\"54 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of the symposium: vaccines, biopharmaceuticals, in vitro diagnosis, management, other related themes\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.35259/isi.2022_52256\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of the symposium: vaccines, biopharmaceuticals, in vitro diagnosis, management, other related themes","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.35259/isi.2022_52256","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Determining identity, purity and activity of Benzonase® endonuclease applied on the Recombinant Covid-19 Vaccine active pharmaceutical ingredient production
gel was able to detect the presence of putative contaminant proteins in amounts as low as 0.6 μg. The enzymatic activity by UV-Visible method proved to be precise and robust for variations in the incubation time on ice and wavelength of reading. The validation of ICP-OES method for the elemental impurities complied with selectivity acceptance criteria and showed an acceptable sensibility degree. Conclusion: Our results providing sufficient evidences to demonstrate that all assays are suitable for its intended purpose. This multidisciplinary work is now part of the routine of analysis required before Benzonase® utilization in the production of the Recombinant Covid-19 Vaccine API by Bio-Manguinhos/Fiocruz.