SARS-CoV-2 and the safety margins of cell-based biological medicinal products

Biologicals. 2020 Nov:68:122-124. doi: 10.1016/j.biologicals.2020.08.010. Epub 2020 Aug 29.

Abstract

With the pandemic emergence of SARS-CoV-2, the exposure of cell substrates used for manufacturing of medicines has become a possibility. Cell lines used in biomanufacturing were thus evaluated for their SARS-CoV-2 susceptibility, and the detection of SARS-CoV-2 in culture supernatants by routine adventitious virus testing of fermenter harvest tested.

Keywords: AAT; Adventitious agent testing; Biomedical products; CHO; Cell lines; HEK-293; HT-1080; Permissiveness; SARS-CoV-2; Safety; Susceptibility; Vero.

MeSH terms

  • Animals
  • Antiviral Agents / pharmacology
  • Betacoronavirus / physiology*
  • Biological Factors / pharmacology
  • CHO Cells
  • COVID-19
  • Chlorocebus aethiops
  • Coronavirus Infections / drug therapy
  • Coronavirus Infections / metabolism*
  • Cricetulus
  • Drug Evaluation, Preclinical
  • HEK293 Cells
  • Humans
  • Pandemics
  • Pneumonia, Viral / drug therapy
  • Pneumonia, Viral / metabolism*
  • SARS-CoV-2
  • Vero Cells
  • Virus Replication*

Substances

  • Antiviral Agents
  • Biological Factors