Making the Biologics Industry’s Hottest Technology Available in Your Own Factory

Sponsored by Enzene

Enzene, a Continuously Innovative Development and Manufacturing Organization (CIDMO™) with facilities in Pune, India, and Hopewell, New Jersey, supports clients from cell line development through drug substance and drug product. In this convention video interview, Russell Miller, Vice President of Global Sales and Marketing, describes the company's EnzeneX® fully connected continuous manufacturing™ (FCCM™) technology for mammalian processes, which he says delivers up to a tenfold increase in productivity along with a significant reduction in cost of goods. Miller cites cost of goods as low as $40 per gram for product manufactured in India and roughly $100 to $120 per gram in the United States.

The conversation centers on NeX™, launched at BIO, which gives biopharma organizations, institutions, and governments access to the platform inside their own operational paradigm rather than through Enzene's sites alone. Miller details the modular components that make up the program: the SparX™ training academy, a six-to-nine-month program Enzene has run for years to build bioprocess development skills locally; design and build capability drawn from Enzene's own facilities, where each suite produces half a ton of material and two suites were installed at Hopewell for $50 million in a 1,500-square-foot footprint; the continuous manufacturing platform itself; and development support that stays in place so client teams can operate successfully from day one. He contrasts that capital profile with traditional fed-batch multi-ton capacity, which he says typically starts at $200 million to $300 million and can approach $1 billion for a stainless-steel installed base.

Miller also traces the origins of NeX to conversations about regionalization and supply chain risk mitigation, pointing to the disruptions manufacturing teams faced delivering vaccines and biologics during the COVID-19 pandemic. Because the program is modular, established biotech hubs may take only the platform and operational support, while emerging markets with limited biologics infrastructure can draw on training, design, and development assistance as well. Biomanufacturing leaders, CDMO partners, supply chain strategists, and policymakers evaluating regional or pandemic-preparedness capacity will find a clear view of what it takes to install and successfully operate continuous biologics manufacturing locally, and how lower cost of goods connects to affordability and patient access.