ATMP Center: custom quality control & GMP services for clinical ATMP development (R-9741)

There is growing evidence that cellular therapies can be used to treat a wide variety of disorders. Indeed, numerous studies performed in vitro and in animal models show its great clinical potential. However, translation of cell products from the preclinical to clinical grade setting requires specialized facilities and trained personnel to meet the good manufacturing practice (GMP) regulations of the European Medicines Agency (EMA). Such facilities and experts are lacking in the value chain of spin-offs and small to medium sized enterprises that need to implement the strict production standards of GMP in their manufacturing process. Currently, GMP product development must be outsourced to contract manufacturing organizations (CMO). In this POC project, the business case for a center of excellence for advanced therapy medicinal product (ATMP) manufacturing will be cross-checked with and for its potential market. This center has the advantage over existing CMOs in that it will enable early stage biotech companies to keep control of both know-how and GMP manufacturing processes to take their next steps towards clinical production.

Keywords:STEM CELLS

Disciplines:Cell therapy