Mayo Pujols, CEO of Andelyn Biosciences, discusses how Cell & Gene companies are focusing on reliability and predictability to further advance this innovative therapy.
Why is reliability such an issue in GMP manufacturing in the cell and gene space? What makes the cell and gene space unique in trying to improve reliability?
MP: Reliable and consistent production of cell and gene therapies is critical to ensuring timely treatment of patients with medical conditions that in many cases are rapidly progressing. Regulatory authorities and manufacturers also expect cell and gene products to be produced with a high level of predictability. These products are made from biologic material and the smallest change can have a varying impact on product performance. As a result, reliability and predictability are the focus of the industry to eliminate the need for repeat work that can slow down treatment and potential doses. In cases where these therapies are produced by contract development and manufacturing organizations, reliable production is also an important factor in the firm’s overall reputation.