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

Annals of the symposium: vaccines, biopharmaceuticals, in vitro diagnosis, management, other related themes Pub Date : 2022-01-01 DOI:10.35259/isi.2022_52256

Débora Oliveira, Weslley Santos, I. Santos, Karolyne Ruibal, Lucas Silva

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引用次数: 0

摘要

凝胶能够检测到低至0.6 μg的假定污染蛋白的存在。紫外可见法测定的酶活性对冰上孵育时间和读数波长的变化具有较好的准确性和鲁棒性。ICP-OES方法对元素杂质的检测符合选择性接受标准，具有可接受的灵敏度。结论:我们的结果提供了足够的证据来证明所有的检测方法都适合其预期的目的。这项多学科工作现在是Bio-Manguinhos/Fiocruz在生产重组Covid-19疫苗原料药中使用Benzonase®之前所需的常规分析的一部分。

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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.

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Annals of the symposium: vaccines, biopharmaceuticals, in vitro diagnosis, management, other related themes

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