Considerations for manufacturing of cell and gene medicines for clinical development

The global changes from 2001 which elevated substantially modified cell therapies to the definition of "medicinal product" have been the catalyst to the dramatic expansion of the field to its current and future commercial success.Europe was the first to incorporate human somatic cells into drug legislation with the medicines directive of 2001 (2001/83/EC) which led to the development of the term Advanced Therapy Medicinal Products (ATMP) to cover all substantially modified products, tissue-engineered products and somatic cells which are not substantially modified but which are used non-homologously. For convenience I will use the term ATMP throughout this review.The transition from "cell therapy" to "cellular medicine" coincided with changes in clinical trial legislation in Europe and, subsequently across many drug jurisdictions throughout the World. As medicines, there is a clear path through multiple phases of trials and associated requirement for compliance with the GxP standards of drug development, and manufacturability is central to this development.