Indian biomanufacturing company Enzene Biosciences is set to open a 54,000-ft² facility near Princeton, NJ, later this year as its first North American production site. The CDMO offers a fully connected continuous manufacturing (FCCM) process for mammalian-based systems. Gadgil discussed his company’s EnzeneX continuous-manufacturing platform, which will be implemented at the New Jersey site later in 2024. Gadgil described the platform as “perhaps the only fully connected continuous manufacturing platform that is available through a CDMO,” with fully end-to-end capabilities.

Gadgil defined continuous manufacturing from a bioprocessing perspective as a technique that enables companies to have a consistent stream of products being completed. He said that can be done by using multiple bioreactors and integrating them with a downstream process. He explained that to reduce cost of goods (CoG) and overall carbon footprints, it is important to connect unit operations. Enzene is currently able to manufacture 10 kg of product per batch in its 1200-ft² cleanroom, with a goal of reaching 40 kg per batch next year and thus reducing costs for clients to US$50 per gram.

Gadgil said that in the past two years, Enzene successfully converted 30 fed-batch processes into its continuous platform with a 100% success rate. “We haven’t really seen a product that works in fed-batch that does not work in perfusion,” he said. Conversely, the company has five products in its pipeline that did not work in fed-batch. But he emphasized that “any product that works with fed-batch should work with continuous manufacturing.”

The company currently is implementing its new EnzeneX 2.0 platform, which will integrate analytics into the existing platform for providing real-time, continuous data. Enzene will update its sites with the new platform when it is available, including the New Jersey site. Gadgil stressed the importance of bringing Enzene’s best available technology to the United States.

Enzene’s long-term goal is to become a modality-agnostic CDMO for biologics. Gadgil expressed his company’s interest in viral vectors, gene therapies, and ADCs and stated that it is already in talks with clients that are seeking clinical development work. The company seeks to provide services further upstream and support clients in discovery and then branch out into manufacturing those new modalities. Enzene is prepared to do all the biological infrastructure work, including manufacturing reagents and performing assays. Gadgil said that for discovery studies, “we have a full-fledged platform that allows us to do that.”

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See full presentations online at https://bioprocessintl.com/category/bpi-theater/bpi-theater-bio-2024.