This week, Process Development Forum speaks with Parrish Galliher, Chief Technology Officer Upstream at Cytiva, about trends within the bioprocess area.
What’s one of the biggest trends shaping the biopharma manufacturing space?
Single-use adoption moving into commercial production. It’s well underway and is moving into commercial plants—we know of five single use facilities around the world that are either licensed or are in the process of being licensed for commercial manufacturing.
Is licensing for single-use difficult to achieve?
It’s not as challenging as people thought it would be. Agencies are giving the go-ahead and recognize the benefits for a manufacturing quality control perspective. In addition to Shire HGT in the U.S., there are commercial plants now licensed or going commercial in Japan, Australia, Korea, and India.
How will increased adoption of single-use impact the industry?
On a commercial level, it will save companies a lot of capital compared to stainless steel facilities. Since 90% of drugs fail during the 7-8 years of clinical testing, and plants are traditionally built 5 years ahead of launch, sometimes an investment is made in a plant for a drug that won’t succeed. Single-use facilities can be built in half the time, so companies can begin construction later in the clinical development process, which reduces capital risk.
There are other factors that are helping to mitigate the risk as well—smaller markets, increased titers and improved processes help shrink plant-sizes ten-fold. And, since single-use facilities are smaller and simpler, so they can be built faster. If you roll all those factors together, you can see how single-use can reduce financial risk and improve efficiencies.