A Holistic Approach To Keep Pace With Manufacturing New Modalities

By Morgan Norris, Vice President of Marketing, at Pall

If there’s one phrase I might use to describe how I feel about the industry today, it’s “cautious excitement.” Monoclonal antibodies are still king in biotech and remain the biggest selling drugs in the world. We also know a lot about them; we know how to design, develop, and manufacture them efficiently and they are not going away any time soon. But there are many diseases that monoclonal antibodies or even recombinant protein therapies are not well suited to treat – such as more severe diseases with very small patient populations. This is the space now being filled by gene therapy. We have seen some truly exciting successes and it’s clear that viral vectors are also here to stay; however, there is a bottleneck in terms of manufacturing capacity that is limiting the development of gene therapies. How will the industry cope with the increasing demand given the relatively low process yields, high cost of goods, and suboptimal unit operations?