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.
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