ASSAY DEVELOPMENT


apceth Biopharma’s development, optimization and validation of assays for routine GMP testing include the following services.

1) In-process and release testing of cell therapy products (ATMPs):

  • Flow Cytometry for surface and intracellular markers of mesenchymal stem cells (MSC), hematopoietic stem cells (HSC), lymphocytes, monocytes, dendritic cells and so on
  • Flow Cytometry of CD34+ stem cells according to ISHAGE guidelines
  • Flow Cytometry for immuno-phenotyping
  • Real time PCR (qPCR) for the determination of vector copy number (VCN) of genetically modified ATMPs
  • Cell-based potency assays
  • Soft agar assays
  • ELISA (quantitative and qualitative) for the determination of impurities and cytokines
  • Cell count and viability assays (e.g. Trypan Blue; AO/PI)
  • Determination of DNA concentration

2) Stability testing of drug products according to ICH guidelines
3) Responsibility for microbiological testing (sterility, endotoxin, mycoplasma) of drug products
4)  ID testing for critical raw materials in-house and at contract laboratories