Cell Therapy

Cleans Cells has very early been committed to the development of Advanced Therapy Medicinal Products (ATMPs) and highly involved in cell therapy as an integrated CRMO. Our services cover the manufacturing of small clinical batches of cell therapy products and the characterization of the starting material and products of the different steps of production, up until the final product.

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.

Capacities

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Quality Control

Our laboratories and specific equipments allow us to perform a large array of methods for cell 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
  • Bacterial endotoxins assay
  • Tumorigenicity

A portfolio of more than 200 qPCRs allows a fast and sensitive detection or quantification of a large number of micro-organisms from various species.

Compliance

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.

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