July 31, 2024
Sundar Ramanan, chief quality officer, Enzene Biosciences
Enzene offers a novel platform for commercially available, fully connected, continuous manufacturing (FCCM) platform. Traditional fed-batch manufacturing comes with many challenges that hinder biologics development. Independent operations use multiple large bioreactors and holding tanks, resulting in inefficient set ups and high inventory costs. Manual intervention and large facility carbon footprints lead to unsustainable manufacturing solutions, making compliance and contamination control difficult to manage. High capital costs render fed-batch production impractical for small, emerging biotechnology companies needing to expedite molecule development. And many people around the world have limited access to biologics. Ramanan said that such concerns could be addressed by adopting technologies for FCCM.
FCCM is an automated manufacturing method in which process fluids seamlessly flow from upstream to downstream phases. An FCCM platform such as the EnzeneX system can reduce costs significantly, improving affordability and accessibility of biologics to expanded markets. The EnzeneX technology entails uninterrupted processing from initial cell cultures to final drug substances; integration of such processes ensures consistent product quality and accelerates time to market. Designed with flexibility in mind, the EnzeneX process is primed for scalability as well.
Ramanan listed several key quality-compliance advantages of an FCCM system. Implementing the concept is less complex than construction, commissioning, and qualification for traditional fed-batch manufacturing processes. FCCM procedures incorporate contamination control by design within closed systems. Quality profiles are improved because operators are removing products from bioreactors constantly. Scale-up risks are eliminated because FCCM processes can be scaled out or extended in duration, increasing compliance and efficiency while reducing production costs.
The EnzeneX platform brings to biomanufacturing fully validated methods, increased productivity, reduced costs, high-quality products, flexible designs, and reduced emissions. Perhaps the most important advantage of FCCM is that it can increase access to medicine for those in need. “If you were to look at access to biologics, most people on earth (both in ICH regions as well as globally) don’t use medicines,” Ramanan noted. “People ration [medicines] because of costs, and cost is a limitation to access to biologic therapies.” Enzene’s goal is to ensure global access to affordable biologic medicines. Having done so in India, the company will turn its focus to Europe and the United States. Enzene is building a manufacturing site in New Jersey to bring its technology overseas. US Food and Drug Administration (FDA) approval of the facility will occur soon, and the site will be launched late in 2024.
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