Quality controlQuality control testing : at the core of our expertise
Companies Clean Cells, Biodextris and Naobios have been involved since their creation in the testing of thousands of biopharmaceuticals including vaccines, cell and gene therapies, antibodies, recombinant proteins, and many more, including countless characterization projects in accordance with GMPs.
Clean Cells is a worldwide market leader in the quality control testing of pharmaceutical products and has developed a substantial GMP assay portfolio critical to their evaluation according to biosafety, purity, identity and potency criteria.
In 2019 and 2021, Naobios and Biodextris respectively brought their analytical capacities including physicochemical, titration and quantification methods as part of manufacturing programs.
Evaluation of biological products at the different steps of manufacturing
Our companies benefit from a large panel of assays required to the full evaluation of biopharmaceuticals and of in-process substances at pre-clinical, clinical and commercial phases according to global regulatory guidelines. All steps are covered by our analytical capacities and include:
- Reagents and media
- Cell and virus banks
- Drug substance
- Drug product
- Ancillary products
- In-process controls
Methods specific to quality control testing of biologics according to Good Manufacturing Practises
Biological products need specific scientific expertise and regulatory knowledge due to their particular nature. Clean Biologics offers a number of validated methods for the complete evaluation in a GMP context of the following criteria:
- Biosafety: includes sterility testing, mycoplasma detection and eradication, adventitious virus and retrovirus testing (in vitro, in vivo);
- Identity: includes qPCR/RT-qPCR based assays;
- Purity: qPCR and ELISA based detection and quantification of impurities
- Potency: titration, cell-based assays and custom-made assays.
- Physicochemical properties;
Customized development and validation of assays
Some biopharmaceuticals need customized characterization. Clean Biologics offers its extensive analytical capacities to develop and validate bespoke assays according to your specifications and defined regulatory guidelines (ICH, FDA, EMA, JP, ChP, etc.).