key: cord-0966285-vbdb76mo
authors: Modrof, Jens; Kerschbaum, Astrid; Farcet, Maria R.; Niemeyer, Daniela; Corman, Victor M.; Kreil, Thomas R.
title: SARS-CoV-2 and the safety margins of cell-based biological medicinal products
date: 2020-08-29
journal: Biologicals
DOI: 10.1016/j.biologicals.2020.08.010
sha: 6f31fda8ce37097f158019303b2467ef9c2561b8
doc_id: 966285
cord_uid: vbdb76mo

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.

A general concern in cell-based manufacturing of recombinant proteins, including vaccines, 44 is the potential contamination of the cell culture with viruses, which has had severe 45 consequences for patients and manufacturers [1, 2] . With the pandemic emergence of SARS- 46 CoV-2, the exposure of biomanufacturing cell lines to a new virus has become a possibility, and to safeguard biomedicines it is important to understand whether the virus is even capable 

SARS-CoV-2 infectivity titers were detected until day 7 p.i. (Table 1). Whether these References

Viral contamination in biologic manufacture and implications for emerging therapies

Virus susceptibility of Chinese hamster ovary (CHO) 221 cells and detection of viral contaminations by adventitious agent testing

Points to Consider in the Characterization of 224

Cell Lines used to produce Biologicals