White Paper

Isolator Advantages in Cell Therapy Production

Source: Extract Technology

By Matt Pridden

Meeting Challenging Containment Demands For Cell Therapy Production

While numerous cellular and gene therapy products have seen strong initial clinical successes, only 14 have been approved for use by the FDA to date. However, this continued success has driven significant investment in these next-generation technologies by both large bio/pharma companies and start-up specialist firms backed by venture capital dollars. More than 750 companies worldwide declare themselves to be in the “regenerative medicine” market space. From 2015 to 2016, there was a 21% increase in the number of cellular and gene therapy drugs in clinical trials, with 271 in phase I, 465 in phase II and 66 in phase III.

Of course many of these companies are eager to join the minority and advance beyond early clinical trials to phase III and commercial products, but they lack the manufacturing capability.

There is a significant need for equipment manufacturing partners with the specialized expertise necessary to innovate and implement novel manufacturing solutions that will help accelerate the commercialization of these advanced treatments that have tremendous potential to improve patient lives.