DCAT Week 2025: Industry Need for Continuous Biologics Manufacturing

Editor's note: this interview was originally published on BioPharmInternational.com.

Although perfusion-based biologics manufacturing has been around for decades, the biopharmaceutical industry has historically favored fed-batch processes. Now, however, regulators are showing increased interest in continuous manufacturing, similar to the adoption of continuous manufacturing in small molecule production, says Russell Miller, vice-president, Global Sales & Marketing, Enzene, in an interview with the PharmTech Group ahead of DCAT Week 2025, which is being held on March 17–20 in New York City.

Enzene has been pioneering the shift towards fully connected continuous bioprocessing, Miller emphasizes. He explains that only fully connected continuous manufacturing integrates the entire production process, from bioreactor to downstream purification, in a seamless flow. Fully connected continuous manufacturing platforms offer several key advantages, such as reducing the cost of goods, enhancing product quality by preventing degradation such as that seen in longer fed-batch runs, and boosting productivity up to 10-fold.

In addition, a fully connected continuous process can compress the number of batches required to support clinical trials, which can accelerate the path to clinic, he states. Yet, despite these advantages, only about 2% of biologics are currently manufactured continuously.

“[It] is my feeling that continuous manufacturing is on the forefront of a change in biologics manufacturing as we move forward. It has the opportunity to solve different problem statements that clients may have, whether it's product quality or cost of goods or productivity. [Those] are some pretty compelling areas that folks pay attention to when it comes to biologics, especially in the mammalian [cell culture-] based processes, because these are not things that happen in a day or so. Biologics manufacturing from mammalian-based systems take 12,14, 18, 20-plus days to execute, and that's a lot of time and planning. So, anything that can be done to make that time more efficient, more productive is beneficial to the industry,” Miller says.

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About the speaker

Russell Miller, Vice-President, Global Sales & Marketing, Enzene

Russell Miller is a results-oriented business development leader with more than two decades of experience driving growth in the pharmaceutical and biotech industries. His expertise spans analytical services, formulation development, and manufacturing, providing him with a deep understanding of the drug development process. Spending more than a decade at Catalent Pharma Solutions, he consistently exceeded sales targets and spearheaded strategic initiatives, including the successful reinvigoration of sales in the Northeast region and the design and implementation of a global Inside Sales Group. He has also held leadership roles at Vectura, ANI Pharmaceuticals, and Scotwork, consistently demonstrating his ability to establish companies as leading contract development and manufacturing organizations, reinvigorate sales funnels, and streamline operations. At Enzene, Miller's focus is on forging strategic partnerships and delivering solutions that exceed expectations, driving the company's continued success.