Gene therapies are no longer a promise for the future. A growing number of approved treatments are already transforming the lives of patients with rare genetic diseases, and advances in gene editing continue to expand what may be possible. Yet turning scientific breakthroughs into therapies that can reliably reach patients remains a major challenge.
While researchers have made enormous progress in developing gene therapies, manufacturing is still a significant barrier to wider adoption. Scaling production, ensuring consistent product quality and meeting evolving regulatory expectations continue to test developers as more candidates move toward commercialization.
At the same time, the industry is entering a more mature phase. Early commercial successes — and setbacks — have generated valuable lessons that are reshaping how new gene therapy programs are designed, manufactured, and prepared for launch. Developers are increasingly considering commercial manufacturing and patient access much earlier in development, with the aim of avoiding the delays that affected many first-generation products.
In this video interview, Phil Wills, Chief Commercial Officer of the Cell and Gene Therapy Division at Catalent, discusses how gene therapy manufacturing has evolved over the past decade, the bottlenecks that still need to be overcome, and why the next wave of therapies could have a much smoother path from the laboratory to patients.
