Addressing The "Capacity Crunch" With A Scalable Platform Process Approach

By Brianna Barrett, Ph.D., and Danielle Sexton, Ph.D., Forge Biologics

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing.

Encouragement from regulatory agencies has prompted more CDMOs to adopt a platform process approach. As knowledge and experience from the past 40 years is applied, manufacturing strategies can be accelerated to increase access to life-saving gene therapies. A platform approach with the flexibility to adapt to individual client needs can provide a head start on development that saves both time and money.