Securing Opportunities for Continuous Processing Technologies

Securing Opportunities for Continuous Processing Technologies ...

In the large-molecule manufacturing, continuous processing is at an all-time high. Here GEN talks with Antonio Moreira, PhD, the University of Maryland, Baltimore County (UMBC) about his keynote on future months' Bioprocessing Summit discussing opportunities for continuous manufacturing and process analytical techniques.

GEN: What is your major message in your outburst?

Moreira: There's a huge push to make manufacturing processes as efficient as possible in order to ensure that medicines delivered to patients are of consistently high quality and are safe and efficient. Continuous processing is a way to achieve those goals, and advances in process analytical technologies (PAT) are required to bring it to fruition.

GEN: Where is the industry in terms of end-to-end manufacturing?

Moreira: There are companies that are developing end-to-end medications for small molecules. There are companies on the market such as ORKAMBI (Vertex), PREZISTA (Janssen) and DAURISMO (Pfizer) that include continuous drug product manufacturing. For larger molecules, I havent heard a company claim to have accomplished end-to-end.

GEN: Why was end-to-end adoption first in small molecules?

Moreira: Small molecules involve simpler steps, such as a chemical reaction, and clearly defined process steps, and there are plenty of tools for analytics.

When it comes to biological goods, youre dealing with a living biological system. The molecules are complex, and you need good equipment to understand the product characteristics, which is a large task, even in a batch process.

People still need to establish a business case for continued biologic manufacturing, and, in general, the biopharma industry is still a little apprehensive about new technology. It takes a little time to get things before regulators.

GEN: Why is continuous processing necessary?

Moreira: Without PAT, you cant have continuous processing. If youre running a process all the time, you need special supervision and control to meet quality standards. So, basically, PAT tools are your eyes looking into the process.

GEN: What do you anticipate to happen in the future when PAT tools and implementation?

Moreira: More companies are talking about ongoing biologic manufacturing, and there's a justifiable business case because of the productivity and efficiency benefits you get while reducing the footprint of your facility. In the relatively near future, in the next three years, you'll see products made using continuous bioprocessing.

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