Cell Culture Media: An API or Ancillary Material?

Cell culture media are used to manufacture cell-based therapies. A number of essential materials are involved in the manufacture of cell-based therapies, including the active pharmaceutical ingredient (API), ancillary materials (AMs), and raw materials (RMs). Regulatory measures are needed to ensure the safety and quality of AMs and RMs used — measures that differ from those used for APIs. Although current regulatory guidelines exist for RMs, they are limited in certain aspects. In addition, some gene-editing components used in cell therapies may not have clear classification as either APIs or AMs, which raises challenges in determining the type of regulatory measures that need to be followed.