With the FDA approval of the first CAR-T therapies, the cell and gene therapy space has reached another milestone in 2017. Kymriah™ and Yescarta™ are pioneers of a fast growing field in which an increasing number of advanced therapy medicinal products (ATMP) manufacturers are reaching commercial phase.
The strong expansion of the cell and gene therapy space brings many challenges to the manufacturers of ATMPs. As a result we’ve seen a lot of progress in accomplishing consistent large-scale manufacturing on a global scale. One of the biggest challenges in achieving this is the elimination of variations, especially in starting and raw materials (also called ancillary materials) and manual manufacturing steps. To eliminate variations in raw materials we see an increased demand for GMP raw materials and an increased need for regulatory guidance. As a provider of GMP raw materials we are actively raising awareness of the need to use high quality GMP raw materials and are in constant interaction with regulatory authorities worldwide.
Furthermore, as described in the guidance on microbial and viral safety of Ph. Eur. chapters 5.2.12 and 5.1.7, recombinant proteins must be derived from fully traceable and well-characterized Master Cell Banks.