Biologics and stem cells represent nowadays some of the most promising approaches to treat and cure so far intractable diseases and pathologies such as cancers, diabetes, ... The production of these medicines requires highly secure and controlled manufacturing process environments in which adventitious contaminations such viruses and bacteria are strictly forbidden from end-products for safety reasons.
The biopharma companies and Contract Manufacturing Organization (CMO) are actively looking for new and more robust (speed and sensitivity) diagnostics PCR-based tests to comply with the tighter and tighter safety regulations and, for instance, to mitigate contaminations coming from bacteria, molds, yeasts, viruses, Mycoplasma, as well as cross contamination by other cell lines.
- Design and validation of in-vitro diagnostic, and analysis tests.
- Identification of viral and bacterial contaminants.
- Detection of the presence of host-cell genomic DNA, gDNA in biopharma processe.