Quality control assays for cell therapy products
Clean Cells is a long-standing supporter of the development of Advanced Therapy Medicinal Products (ATMP) and more particularly of cell therapy products. Our biopharma quality control offer includes a full portfolio of tests and assays to characterize starting material and products at all the stages of biopharma manufacturing, up to the final batches and lots.
Our Good Manufacturing Practices (GMP) certification is complemented by full validation of methods according to criteria defined in ICH Q2R1 and relevant guidelines.
Our experience is built upon many collaborations with public and private partners of all sizes worldwide.
BSL-2 and BSL-3 levels are offered to meet diverse specifications when testing for biological substances and in-process material:
- Biosafety testing
- Sterility testing according to 2.6.1 or 2.6.27 (BacT/ALERT automated system)
- Mycoplasma detection via culture, epifluorescence, or qPCR-based method
- Virus and adventitious contaminants detection (in vitro, in vivo, TEM) including bovine/porcine contaminants detection and retrovirus detection (PERT)
- Identity testing (cell line authentication), genetic characterization (GCN, VCN) and cytogenetics tools (karyotype studies, G-banding, FISH, etc.)
- Impurities or residues quantification: HCP, residual DNA, BSA/Benzonase, endotoxins assay
Detection and quantification of 200+ contaminants is permitted through an extensive portfolio of validated qPCR assays. The list can be issued on request.
Our portfolio is also available in R&D grade (non-GMP).
Reach out to our team of specialists to discuss bespoke development and/or validation needs.