Cleans Cells has very early been committed to the development of Advanced Therapy Medicinal Products (ATMPs) and highly involved in gene therapy as a CRO. Our services cover the manufacture of substrates used for vector generation and the characterization of the starting material and products of the different steps of production, up until the final product but also for clinical monitoring purposes.
Our extensive collaboration with major companies of the field helped us develop a large portfolio of assays along with the regulatory compliance and expertise required for the design of relevant characterization strategies based on the specificities of your project.
2- Quality Control
Our laboratories and specific equipments allow us to perform a large array of methods for in vivo and ex-vivo gene therapy products and their intermediaries:
- Sterility testing according to 2.6.1 or 2.6.27 (BacT/ALERT automated system)
- Mycoplasma detection via culture, epifluorescence or qPCR
- 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, viral sequences or genetic elements of interests (plasmids)
- Bacterial endotoxins assay
- Replication competent virus testing (RCL, RCAAV)
- Physical or infectious vector titre determination
- Cytotoxicity (potency) read-out method for CAR-T projects
Some of these methods such as RCL and VCN testing may also be applied for clinical monitoring purposes (shedding studies).
Clean Cells is a CRMO with GLP & GMP certifications issued by the competent regulatory authorities.
Our assays comply with global regulatory guidelines, notably issued by the EMA, FDA, ICH and WHO.