Q.C testing – Product characterization

We advise and assist our clients in fulfilling their testing needs including the development of specific assays that address challenges encountered during product development:

  • Development, qualification and validation of analytical methods
  • Product Testing and Characterization: identity, purity, strength/potency, stability and safety.

We’ll foster a flexible approach and open communication with you and the product manufacturer (whether based in Europe or in the USA).

For cell and gene-based treatment approaches, GenoSafe has unique expertise in the quality control of preclinical and clinical batches.

Focus on AAV vectors

  • Virus titer (genome copies)
  • Infectious vector titer
  • Detection of replication-competent AAV (rcAAV)
  • Detection of process and product –related impurities: plasmid DNA, cellular DNA and proteins, helper/hybrid virus DNA, transgene protein product …
  • Transgene functionality
  • For manufacturing process based on on a baculovirus expression vector system: Detection of insect cell-specific sequences, Residual baculovirus DNA, baculovirus protein assay

Focus on lentiviral vectors

  • Titration of physical particules (concentration in HIV-p24 capsid protein)
  • Infectious vector titer
  • Detection of replication-competent lentiviruses (RCL)
  • Detection of process and product –related impurities: plasmid DNA, cellular DNA and proteins, transgene protein product …
  • Transgene functionality

 

Focus on Cell Therapy and ex vivo Gene Therapy approaches

  • Cell surface marker detection assays by flow cytometry analysis
  • RNA profiling of stem cells marker by RT-qPCR
  • Measurement of the vector copy number (VCN) per cell in CD34+ hematopoietic stem cells (HSC) transduced with a vector
  • Detection of replication-competent lentiviruses ( RCL) in human hematopoietic stem cells (HSC) transduced with a lentiviral vector
  • Evaluation of the efficacy and hematopoietic toxicity of a vector by measuring the transduction, viability and clonogenicity ([CFU] of CD34+ Haematopoietic stem cells (HSC) from human umbilical cord blood (UCB)