Cell therapy is a field of medicine that involves injecting intact, living cellular material directly into a patient for the treatment of disease. Recent advances include isolation and infusion of specific stem cell populations, introduction of effector cells, and reprogramming of mature cells into a pluripotent state for numerous differentiated cellular therapeutics. Cell therapy holds tremendous promise for several applications including targeted drug delivery, tissue repair, and immunotherapy, all of which could ultimately contribute to the treatment of a wide range of diseases and conditions.
The rapid growth rate of cell therapy research and development has not allowed for accepted laboratory practices and clinical development to develop harmonized standards for components, processes, or products. Crucial needs include reference guidelines and characterization analytics. SCB supports ongoing initiatives through NIST, ISO, and other standards stakeholder organizations for the development of consistent and reproducible methods to measure cells’ functional response to their environment, which is a useful technique for testing drug effectiveness and toxicity. An example of a standard these organizations are working on is the consistent evaluation and comparison of cell counting methods. Other SCB initiatives intend to support rapid sterility testing for microbial contaminants, managing particulates, and flow cytometry applications. The Cell Therapy Sector is Co-Chaired by Dr. Michael Mendicino and Dr. Krishnendu Roy, whom together provide a wealth of experience in both industry and academic research capacities.
Dr. Michael Mendicino, Hybrid Concepts International, LLC
Dr. Krishnendu Roy, Cell Therapy Manufacturing Consortium