Risk Management Processes For Cell And Gene Therapies

Newly approved cell and gene therapies are delivering remarkable outcomes for patients who would otherwise have exhausted all other treatment options. This success, combined with a deeper understanding of the underlying biology, is driving significant growth within the industry. As a result, more companies are investing in these innovative therapies to enhance their market offerings.

Human gene therapy involves altering genetic sequences or the transcription and translation of transferred genetic material. Cell therapy, on the other hand, works by transferring cells into a patient to treat or cure a disease. Methods include blood transfusions and more complex processes such as extracting cells from the body, introducing a new gene or rectifying a defective one, and reintroducing the modified cells.

Explore several considerations regarding risk and knowledge management in the cell and gene therapy environment that provide essential insights for effective product development.