Clive Glover, strategy director and cell and gene therapy lead at Pall Corporation, explains why we need to take a more holistic approach to gene therapy manufacturing processes.
Industry 4.0
In just a few short years we have seen a huge surge in the development of new gene therapies. There are currently over 1,000 cell and gene therapy clinical trials underway worldwide. While the majority of these are still in phase I or phase II, there are over 90 trials in phase III. Scott Gottlieb, former commissioner of the US Food and Drug Administration (FDA) stated at last year’s BIO International Convention that he expects the FDA to approve 40 gene therapies by 2022.
The gene therapy revolution is happening. But despite all this promise and the rapid growth of an emerging industry, we’re still a long way from seeing gene therapies being manufactured in quantities even close to the level of current demand. This is arguably one of the biggest challenges in modern medicine manufacturing and an area in which we at Pall are investing heavily, namely how to scale up the manufacture of gene therapies and gene-modified cell therapies to industrial levels and do so in a way that remains efficient and cost-effective for those companies producing the treatments. If this revolution in healthcare is going to achieve its potential, we need to solve this manufacturing challenge first.