The field of advanced therapy medicinal products (ATMPs) is maturing, and logistics puzzles are becoming increasingly common. The ATMP class of products broadly includes cell therapies, gene therapies and tissue-engineered products but precise definitions vary from country to country. For example, the FDA distinguishes between ATMPs (which it defines as cellular therapy products including cellular immunotherapies) and human gene therapies (products that introduce genetic material into a person’s DNA to replace faulty or missing genes).
However, despite the complex logistical, manufacturing and safety challenges of developing ATMPs, companies have flocked to the field, drawn by the potential of these medicines to produce durable clinical benefits with few systemic side effects. This article looks at four trends that will guide the evolution of this critical and expanding field.