Frequently Asked Questions

Biosafety Testing

Sample qualification depends on the specific test being requested and what is meant by qualification; most of BioOutsource’s biosafety assays include a positive control spike which represents an in–assay qualification. This is performed every time a sample is sent. As long as there are no changes in the products manufacturing process, sample qualification only needs to be performed on the first occasion.

All biosafety testing at BioOutsource is performed to cGMP quality standards. Furthermore, all cell line characterisation, MCB, WCB, EoP Cell Banking and Bulk Harvest testing are performed to cGMP standards.

Regulations for a biosafety test will depend on the regulatory jurisdiction of the client, or in which geographical location the product has been licensed. If EU-licensed, the testing should be performed according to the European Pharmacopoeia guidelines. Products licensed for the U.S. market would follow U.S. Food and Drug Administration (FDA) guidelines, etc. BioOutsource offers tests which are compliant with worldwide guidelines to satisfy all markets. In general ICH guidelines cover both regulatory agencies.

Yes, BioOutsource can offer this service and will grow cells according to client’s cell culture regimen using the client’s raw materials

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