In accordance with the 2025 edition of the Chinese Pharmacopoeia, Part III, General Chapter 0234 Preparation and Quality Control of Animal Cell Substrates for Biological Product Manufacturing and USP <1237> VIROLOGY TEST METHODS, HyQure Biotech can provide in-process and adventitious virus contamination testing (qPCR method) for cells.
This test checks for potentially infectious viruses from the source species in cell lines/strains, as well as exogenous viruses introduced due to raw materials or handling. The types and methods of virus testing for cells must be determined after a risk assessment of the cell species, tissue origin, cell characteristics, strain establishment and passage history, culture methods, and processes. If the MCB has undergone comprehensive testing, the types of exogenous viruses to be tested for in the WCB can primarily consider viruses that may have been introduced during passage from the MCB to the WCB, while viruses present only before MCB library construction do not need to be retested.
Viral nucleic acid testing provides an alternative approach for determining viral load and identifying contaminants. Nucleic acids and protein antigens are essential components of viruses, and the detectable amount usually indicates the presence of the virus. For viruses with weak replication capacity in tissue culture systems, nucleic acid may be the only detectable viral component. For certain viruses that fail to elicit a response through typical endpoint assays, nucleic acid testing is currently the most effective detection method.
HyQure Biotech provides the following viral contamination qPCR detection services
| Category |
Cell Lines/ Culture Process |
Method |
|
Retrovirus detection |
Except for cells known to produce retroviruses, reverse transcriptase activity should be measured in all cases. |
Product-enhanced reverse transcriptase assay |
| Detection of species-specific adventitious viruses |
Mouse-derived cell lines |
Mouse-derived virus detection (qPCR method) |
|
Human-derived cell lines |
Human-derived virus detection (qPCR method) |
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Monkey-derived cell lines |
Monkey-derived virus detection (qPCR method) |
|
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Insect-derived cell lines |
Insect-derived virus detection (qPCR method) |
|
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Avian-derived cell lines |
Avian-derived virus detection (qPCR method) |
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Bovine-derived virus detection |
The cell matrix used bovine-derived material in its establishment or passage history. |
Bovine polyomavirus detection (qPCR method) |
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Porcine-derived virus detection |
The cell matrix used porcine-derived material in its establishment or passage history. |
Porcine-derived virus detection (qPCR method) |
|
Detection of other specific viruses |
Cells are susceptible to certain specific viruses. |
Mouse microvirus detection (qPCR method) |
|
Vesivirus 2117 detection (qPCR method) |