The key FDA’s and EMA’s biosafety concerns (1,2) are the potential for cell based tumorigenicity, immunogenicity, infectious disease, and or genetic modification.
Two key safety aspects of cellular therapy products include toxicity and efficacy and the establishment of the correct dose. Often this can not be achieved using an animal model. The need for new toxicological and immunogenicity assays using human tissue is clear.
Using the Skimune® Platform to assess Safety and Specificity of Cellular Therapies.
Research by the founder and CEO of Alcyomics, has shown that Skimune® can assist with the assessment of immunogenicity and specificity of cellular products, including, those in use for combatting haematological disorders, viral infections and auto immune disease (3 and 4).
The Skimune® platform has been shown to demonstrate the specificity of T-cell clones developed for use in the treatment of leukaemia and the work was published in Nature Medicine in 2002 (3 and 4). More recently the same Skimune® platform was used to show the safety and efficacy of anti cytomegalovirus (CMV) T cells used in the treatment of CMV post haematopoietic stem cell transplantation.
Through the partnerships created through the NA-ATTC a whitepaper has been produced on the regulations concerning the safety of cellular therapies.
To see more about our work with NA-ATTC watch our video here.