Application Note

SARS-CoV-2 Impact To Biological Drug Products Safety

By Axel Fun, Ph.D., Senior Scientist, Biosafety Testing Services, Glasgow, U.K. and Sarah Sheridan, Ph.D., Technical Consultant, Biosafety Testing Services, Glasgow, U.K

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The current global pandemic of coronavirus disease 2019 (COVID-19), is caused by a newly identified coronavirus (now classified as SARS-CoV-2). Currently, four genera of coronaviruses are recognized: Alphacoronaviruses, Betacoronaviruses, Gammacoronaviruses and Deltacoronaviruses. Alpha- and Betacoronaviruses generally infect mammals whereas Gamma- and Deltacoronaviruses are primarily found in birds. Whole genome sequence analysis places SARS-CoV-2 in the genus of Betacoronaviruses alongside severe acute respiratory syndrome coronavirus (SARS-CoV, now classified as SARS-CoV-1, the etiological agent responsible for the SARS epidemic 18 years ago), Middle East respiratory syndrome coronavirus (MERS-CoV) and SARS-like bat coronavirus1. This analysis revealed that SARS-CoV-2 has highest sequence similarity with SARS-like bat coronavirus and that SARS-CoV-2 is more closely related to SARS-CoV-1 than to MERS-CoV.

It is our assessment that our regulatory compliant in vitro assays using Vero detector cells are a suitable method for the detection of adventitious SARS-CoV-2 in biological samples. We are also prioritizing the implementation of a GMP-compliant PCR assay for the detection of SARS-CoV-2 and offering GMP-compliant NGS analysis for broad spectrum adventitious agent screening as part of our testing packages.

As with any known or new/emerging viruses, a comprehensive testing strategy is required to address the risk of adventitious viruses through the production process, from starting materials to bulk harvest, and as identified through a virus safety risk assessment. This technical note is comprised of a review of currently available literature and our recommended SARS-CoV-2 virus detection test methods and susceptibility of common biological host cells to infection.

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