SARS-CoV-2 and the safety margins of cell-based biological medicinal products. (November 2020)

• Record Type: Journal Article
• Authors: Modrof, Jens; Kerschbaum, Astrid; Farcet, Maria R.; Niemeyer, Daniela; Corman, Victor M.; Kreil, Thomas R.
• Is Part Of: Biologicals. Volume 68(2020)
• Page Start: 122
• Page End: 124
• Publication Date: 2020-11
• Subjects: SARS-CoV-2 -- Biomedical products -- Safety -- Susceptibility -- Permissiveness -- Cell lines -- Adventitious agent testing -- AAT -- CHO -- Vero -- HEK-293 -- HT-1080; Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2020.08.010
• Languages: English
• ISSNs: 1045-1056

Abstract

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.