Preparation and establishment of quality standard for an anti 2019- novel coronavirus inactivated plasma#br#

  • 胡勇 余鼎 何彦林 段凯 杨汇川 侯继锋 梁洪 彭焱 周志军 林连珍 吴晓 喻剑虹 韩韧 梁小龙 邢延涛等
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  • Research and Development Department, Sinopharm Wuhan Plasma-derived Biotherapies Co., Ltd., Wuhan 430207, China; Research and Development Center, Beijing Tiantan Biological Products Co., Ltd., Beijing 100024, China; Laboratory 2 of Viral Vaccine Research, Wuhan Institute of Biological Products Co., Ltd., Wuhan 430207, China; Research and Development Management Department, China National Biotec Group Co. Ltd., Beijing 100029, China; Blood Product Department, National Institutes For Food and Drug Control, Beijing 102629, China;Research and Development Department, Chengdu Rongsheng Pharmaceuticals Co., Ltd., Chengdu 610041, China;             

Online published: 2025-08-16

Supported by

Key Project of Public Security Risk Control and Emergency Technical equipment (2020YFC084180)

Abstract

Objective  To explore the production and quality standard of an inactivated plasma of anti-2019 novel coronavirus(2019-nCoV) prepared from convalescent plasma of COVID-19 patients. Methods  Four hundred and forty-one convalescent samples were collected from COVID-19 patients in Wuhan, China from January to March 2020 and screend for pathogens including 2019-nCoV, HIV, Treponema pallidum and so on. Qualified plasma samples were inactivated by methylene blue light. By carrying out protein content of plasma , anti-2019-nCoV antibody, coagulation factor Ⅷ activity and other tests, the effect of methylene blue light inactivation on plasma was determined and the quality standard was dstablished. Results  Protein content of inactivated plasma did not change significantly before and after methylene blue irradiation inactivation ,coagulation factor Ⅷ activity was ≥ ≥0.50 I U/ml.Antibody titer did not show a significant decrease.All test results met the queality requeirement. Conclusion  The key quality control and process parameters of anti-2019-nCoV inactivated plasma prepared from the plasma of COVID-19 convalescent patients are established.

Cite this article

胡勇 余鼎 何彦林 段凯 杨汇川 侯继锋 梁洪 彭焱 周志军 林连珍 吴晓 喻剑虹 韩韧 梁小龙 邢延涛等 . Preparation and establishment of quality standard for an anti 2019- novel coronavirus inactivated plasma#br#[J]. International Journal of Biologicals, 2021 , 44(1) : 17 -21 . DOI: 10.3760/cma.j.cn311962-20201018-00098

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