Biosafety testing

Part of biologics testing, biosafety testing is a cornerstone of any strategy to secure clinical and commercial products by ensuring that it is free of contaminants. Contamination may arise from live material used to produce biologics or may occur during handling and can have major implications.

Biosafety testing must thus occur at various stages of supply, research and biomanufacturing and follow strict guidelines issued regionally by governmental agencies including FDA and EMA. 

Clean Cells was founded on its expertise at detecting mycoplasma and has since developed a full range of GMP-qualified biosafety testing services for all types of biologics. Using traditional or rapid testing via qPCR, our company supports clients by building quality control strategy best fitted to their product from research to clinic.

Microbiology testing

Microbiology testing is a part of biosafety testing which aims at detecting bacterial and fungal contamination using compendial methods. Viable organisms may be found either through culture assays or molecular (qPCR) may prove useful to detect organisms such as mycoplasma and mycobacteria with a high sensitivity and short timelines. Sterility of products is the basis of a biosafety testing strategy and may be automated for certain types of products using instruments such as the BACT/ALERT 3D, available at Clean Cells.

At the heart of our expertise, we have developed an extensive range of microbiology assays within a larger offer of biosafety testing services. They comply to worldwide guidelines while reducing overall biosafety testing turnover.

Adventitious virus testing

When testing for contaminants, adventitious agents testing looks for microorganisms that may have been brought accidentally to the culture. A combination of in vitro (indicator cell lines) and in vivo testing allows for the detection of a bulk of extraneous agents within biosafety testing.

Clean Cells brings dozens of indicator cell lines for the extensive characterization of adventitious agents for human or veterinary products. These biosafety testing tools can be used in combination molecular methods (PCR).

PCR viral safety testing

PCR viral safety testing occurs complementary to other biosafety testing services. It allows for the detection of specific agents which may not be revealed by other methods, typically through PCR assays. The list of agent-specific tests is established on a case-by-case risk assessment based on literature and experience with authorities.

Clean Cells is a PCR viral testing pioneer with hundreds of references and the expertise to quickly build a biosafety testing strategy which will match expectations from regulatory bodies.

Please reach out to our team for a bespoke biosafety testing plan.

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