Continuous processing is having its moment in large-molecule manufacture. Here GEN speaks with Antonio Moreira, PhD, vice provost for academic affairs at the University of Maryland, Baltimore County (UMBC), about his talk discussing opportunities for continuous manufacture and process analytical technologies at next month’s Bioprocessing Summit.
GEN: What is the key message of your talk?
Moreira: There’s a tremendous push to make manufacturing processes as efficient as possible to ensure products delivered to patients are of consistently high quality and are safe and effective. Continuous processing is a tool to achieve those goals, and advancements in process analytical technologies (PAT) are needed to bring it to fruition.
GEN: Where is the industry in terms of deploying end-to-end manufacturing?
Moreira: There are companies that have end-to-end processes in development for small molecules. There are products on the market such as ORKAMBI® (Vertex), PREZISTA® (Janssen), and DAURISMO™ (Pfizer) that include continuous drug product manufacturing. For larger molecules, I haven’t heard a company say they’ve achieved end-to-end, although they’re getting close.
GEN: Why has end-to-end been deployed in small molecules first?
Moreira: In general, small molecules involve simpler processes, such as a chemical reaction, and well-defined process steps, and there are good tools for analytics.
With biological products, you’re dealing with a live biological system. The molecules are complex, and you need good tools to understand the product characteristics—which is a tall order, even in a batch process.
People still need to make the business case for continuous manufacturing of biologics and, in general, the biopharma industry is still a little cautious about new technology—it takes a little time to bring things to the regulators.
GEN: Why does continuous processing need PAT?
Moreira: You can’t have continuous processing without PAT. If you’re running a process all the time, you need particularly good monitoring and control to meet quality specifications. So, essentially, PAT tools are your eyes looking into the process.
GEN: How do you see PAT tools and implementation developing in the future?
Moreira: More companies are talking about continuous manufacturing for biologics and there’s a justifiable business case because of the productivity and efficiency benefits you get while decreasing the footprint of your facility. I think, in the relatively near future, in the next three years, you’ll see products made using continuous bioprocessing.