Biologics at an Inflection Point: Continuous Manufacturing and Patient Access

Sponsored by Enzene

In this interview, BioPharm International speaks with Russell Miller, SVP of Global Sales and Marketing at Enzene, about the state of biologics drug substance manufacturing. Miller argues that while fed-batch processing has served as a sound industry standard for decades, it will not deliver the patient affordability and access the future demands. He describes the shift toward advanced bioprocessing and continuous manufacturing as a turning point for the industry.

Miller explains that innovation is a core value at Enzene and that the company chose innovation over scale as its path to differentiation. The result is a fully connected continuous manufacturing platform that he says delivers ten-fold productivity gains, cost of goods reductions of 50% to 80%, and drug substance production at $40 per gram. He also outlines how the approach is designed for complex biotherapeutics such as bispecifics and fusion proteins, which are difficult to produce with traditional processes. Miller introduces NeX™, built on an “our plant or yours” philosophy, which pairs a compact manufacturing footprint of roughly 1,500 square feet with training, facility design, validation and qualification support, and a deployable product portfolio for organizations seeking to localize manufacturing and strengthen supply chain resilience.

Biopharmaceutical manufacturing leaders, process development teams, and organizations evaluating CDMO partnerships or in-house capacity will gain a view of how continuous bioprocessing may reshape cost and access. Miller closes with a look at Enzene’s roadmap, including integrated process analytical technology, machine learning and AI, and advanced downstream processing.