GenoSafe

As the development of your gene therapy or cell therapy product proceeds, GenoSafe will support your increasing needs for a specific assay method:

• Development from scratch including a feasibility step
• Optimization
• Qualification for early phases
• Validation according to ICH – Q2 (R1)
• Transfer between laboratories

GenoSafe offers its clients an efficient and continuous approach ensuring the appropriate level of development at the right time according to regulatory guidelines.

Once a lead compound has been identified, the biopharmaceutical development is a long process including preclinical phases and clinical trials to obtain regulatory marketing approval. During this development a variety of analytical technologies are used to assess the characteristics of the product. Many of these methods must evolve into assays that will require validation for their final intended use. Validated test methods are necessary for full compliance with cGMP and GLP regulations.

We perform immunoassay in research grade study, Preclinical (GLP) studies and Clinical (GCP) studies.

We follow-up of the immune response before/after the treatment and help for the Inclusion/Exclusion of patients.

We assess the Cellular response using :
ELISpot
Cytokine/chemokine measurement
ELISA, multiplex
Cell phenotype (flow cytometry)
Evaluation of T‐Cell responses

We assess the Humoral response using :
Anti-drug antibody response
Detection / titration of binding antibodies (ELISA, ECLa (MSD platform))
Detection / titration of neutralizing antibodies (cell-based or not)

Formulation analysis of AAV and Lenti

Viral Shedding analysis (biodessimination)

We advise investigator to define the parameters of the study

Develop and validate the qPCR methods

Perform the study in GLP conditions

Gene and protein expression assays (RT-qPCR, ELISA, W. Blot...)

Bioanalytical Assays Services

Bioanalysis Services

We perform quality testing of produced batches :

• Physical titration
• Viral particles
• Viral genome
• Infectious genomes
• Detection of replication-competent viruses (RCAAV, RCL)