17 November, 2022
Creatio participates in the report on alternative methods by the JRC (Preclinical Studies)
DR. JOSEP M. CANALS PARTICIPATES IN THE JOINT RESEARCH COUNCIL (JRC) REPORT ON ALTERNATIVE METHODS TO TEST IMMUNOGENECITY FOR THE EUROPEAN COMMISSION (EC)
Dr. Canals, Director of Creatio, in collaboration with a group of experts in Advanced Therapy Medicinal Products (ATMPs), produced an in-depth analysis on the current state-of-the-art in advanced non-animal models in biomedical research for immunogenicity testing.
Advanced Therapy Medicinal Products (ATMPs) – encompassing gene therapy, cell therapy, tissue and combined therapies – are promising treatments for diseases where conventional medicine has failed. These can range from cancer, locomotor disfunctions, cardiovascular affections, neurodegenerative diseases to rare genetic disorders. Unfortunately, these promising therapies can trigger some unwanted side effects that countervail their curative properties.
Immunogenicity, where the host rejects the transplant or cells injected, is a common negative effect of ATMPs. Regulatory agencies are responsible for assessing the risk of immunogenicity of new therapies before approval. Unfortunately, the majority of existing standardised tests use rodents and other mammals, which do not mimic the characteristics of the human host environment. Alternative methods such as human cell cultures or 3D human models are seen as a good substitute to validate these innovative therapies. For this reason, the Joint Research Council (JRC) – the science & knowledge centre for the European Commission (EC) – was tasked to assess the current state-of-the-art for alternative methods that test immunogenicity for ATMPs.
Creatio, a production and validation Centre for ATMPs with more than 10 years of experience, has a long-term commitment to the reduction of unnecessary animal use in biomedical practice. Along with the JRC, Dr. Canals participated in the analyses of existing methods with a team of international experts from Spain, France and Italy. Results highlighted a disproportion between the high amount of clinical trials involving ATMPs and the low number of articles focusing on alternative methods to test immunogenicity (only 0.22% of the total). Furthermore, most of these models were not innovative, with the majority using well-established laboratory tests (mostly 2D primary culture T cells) and a clear prevalence for low and/or medium content and throughput analyses.
Dr. Canals emphasised that “this analysis shows that there is a clear unmet need for reliable alternative methods, hampering the possibility that the ATMPs under development reach patients. The scientific community must prioritise the development of innovative and personalised alternative methods”. The expert group believed that the development of platforms with ATMP expertise would be key to define relevant non-animal models for specific scientific questions, whilst maximising needs and opportunities alongside test developers.
See the report at: