Cell and gene therapies are poised to usher in a new era of healthcare. As of June 2021, 14 cell and gene therapies have been approved for clinical application in the United States, and over 400 more are in various stages of clinical trials. The hopes of many patients hinge on the success of these various programs, which are designed to deliver a significant advance on existing treatments or even a functional cure.
As new cell and gene therapies get approved, innovator companies usually get the credit. But many therapies would never make it to market without the expertise and capabilities of contract development and manufacturing organizations (CDMOs) operating behind the scenes.
These novel biologic therapies, while powerful, are also incredibly complicated to develop and produce. Instead of generating a single molecule or protein complex, scientists handle viral delivery vectors and whole cells â€” complex biological systems in their own right. Here, CDMOs are uniquely positioned to leverage the latest technologies and industry-wide expertise. They can assist with process development and quality control, produce key components of a therapeutic product, or even take a biomanufacturing workflow from start to finish.
In some cases, CDMOs can help bring cell and gene therapies to market by accomplishing things that innovator companies â€” especially small biotechs and startups â€” canâ€™t do independently, such as scaling up manufacturing or dedicating entire teams to performing rigorous quality control. In other cases, CDMOs bring subtler value-adds to the table that elevate the quality and reliability of cell and gene therapies.
We interviewed industry experts at FUJIFILM Diosynth Biotechnoloogies, Avomeen, and Intellia Therapeutics, Inc. about the unique ways CDMOs participate in and shape the future of cell and gene therapy development and production. Download this article to read their insights into the need for stability and development expertise, key elements of a good innovator-CDMO partnership, the latest technologies that regulators want to see applied in the cell and gene therapy space, and more.