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A risk assessment study of SARS-CoV-2 propagation in the manufacturing of cellular products
Enric Redondo Monte1, David O'Neill2, Karin M Abitorabi1
1Minaris Regenerative Medicine GmbH. Haidgraben 5, Ottobrunn, 85521, Germany.
Abstract:
The potential infection of cellular therapies by SARS-CoV-2 present high risks, as the target patients for these treatments are often immunocompromised or have chronic diseases associated with a higher risk of serious illness and death by COVID-19. The multicellular tropism of this virus presents challenges for the manufacturing of cell therapies, whereby the material could potentially become infected at the source or during cell processing. In this review we assess the risk of a SARS-CoV-2 propagation in cell types used to date in cellular therapies. Altogether, the risk of SARS-CoV-2 contamination of cellular products remains low. This risk should be evaluated on an individual basis, considering ACE2 and TMPRSS2 expression, existing literature regarding the susceptibility to infection, and single cell RNA sequencing data of COVID-19 patients. This analysis should ideally be performed for both the cells being manufactured and the cells used to produce the vector to ensure patient safety.
Insights
The risk of SARS-CoV-2 infecting cellular therapies is low but requires individual assessment. Evaluating ACE2 and TMPRSS2 expression ensures patient safety in cell manufacturing and vector production.
Area of Science:
- Cellular Therapy
- Virology
- Immunology
Background:
- Cellular therapies treat immunocompromised patients, increasing COVID-19 severity risks.
- SARS-CoV-2 (the virus causing COVID-19) can infect various cell types, posing a threat to cell therapy manufacturing.
- Assessing viral propagation in cell types used for therapy is crucial for patient safety.
Purpose of the Study:
- To review the risk of SARS-CoV-2 propagation in cell types used in current cellular therapies.
- To evaluate the potential for SARS-CoV-2 contamination during cell therapy manufacturing.
- To provide guidance on assessing and mitigating SARS-CoV-2 risks in cellular products.
Main Methods:
- Literature review of SARS-CoV-2 susceptibility in various cell types.
- Analysis of viral tropism and cellular receptors (ACE2, TMPRSS2) relevant to cell therapy.
- Consideration of single-cell RNA sequencing data from COVID-19 patients.
Main Results:
- The overall risk of SARS-CoV-2 contamination in cellular therapy products is considered low.
- Cellular tropism of SARS-CoV-2 varies, influencing infection risk in different cell types.
- Individual risk assessment is necessary due to variations in cellular susceptibility.
Conclusions:
- While the general risk is low, SARS-CoV-2 contamination of cellular products requires careful, case-by-case evaluation.
- Assessing ACE2 and TMPRSS2 expression, infection susceptibility, and patient data is vital for risk mitigation.
- Ensuring patient safety necessitates evaluating both manufactured cells and vector-producing cells for potential viral contamination.
