AURIGON STEERS YOU THROUGH THE CHALLENGE OF NON-CLINICAL SAFETY EVALUATION OF YOUR ATMPS / CBMPS
Over the years, the complexity and variety of cell-based medicinal products (CBMPs) has increased with the growing need for personalised therapy strategies for the treatment of life-threatening diseases. The safety assessment of these products requires a risk-based and tailor-made testing strategy.
So far, Aurigon has tested more than 15 different naïve, expanded and transfected CBMPs of either hematopoetic stem cells or mesenchymal stem cells originating from various tissues such as bone marrow, skin, connective tissue and many others.
We are able to support you in selecting the specific relevant model and testing strategy including the study design for:
- pharmacodynamic testing under consideration of biologic activity, tissue type and abilities/limitations of animal anatomy
- the evaluation of biodistribution and persistence in assessing potential migration and integration in non-target tissues
- tumorigenicity of the clinical product in immunodeficient mice
- potential systemic toxicity and local tolerability in immunodeficient, immunosuppressed or immunocompetent mice.