72 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 It has now been able to showcase the potential of continuous manufacturing for mAbs and other therapeutic proteins through its fully integrated platform, seamlessly linking upstream and downstream operations. The system features continuous media exchange, in-line purification with Protein A chromatography, and real-time pH adjustments, with virus filtration as the only offline step. EnzeneXTM which is a fully-connected continuous manufacturing™ platform operates within a compact footprint by synchronising process unit steps and integrating operations. From perfusion to viral inactivation, followed by anion and cation exchange chromatography, each stage is interconnected in the platform. Time synchronisation and optimized process parameters ensure a steady flow-through mode, enhancing efficiency and reducing space requirements compared to traditional systems. The impact is clear, volumetric productivity has increased from 8-9 g/L in 14-15 days to 60-80 g/L over 30 days and the entire operation fits into a facility just 1,500 square feet in size, a fraction of what is needed for traditional fed-batch plants. The CDMO has set a target to achieve 40 kg per batch, scaling up from 500L to 1KL, with a cost per gram of antibody production as low as $40 with EnzeneX™ 2.0 launched last year. Through process optimisations such as improved cell lines and media, enhanced Protein A efficiency, and incorporation of PAT, the company is steadily driving costs downward. Each iteration brings them closer to their goal, reinforcing the idea that continuous manufacturing is not just about efficiency but about making biologic therapies more accessible and affordable. Enzene will have their newly acquired New Jersey site functional later this year, offering the cost effective, high yielding continuous platform closer to home for its US based customers. The new site is already fully booked for clinical stage animal health projects with work underway to expand and take on more discovery and early stage projects in the expansion suites. The demand for FCCMTM continues to rise as more companies recognize not only its costeffectiveness but also its environmental benefits. By reducing manual intervention and enabling real-time quality assurance, it also enhances reproducibility and process control. Much like the evolution of microchip production, FCCMTM is refining how biologics are made, not just proving its viability but optimizing its scale and implementation. The focus now is on advancing real-time monitoring through automation and the use of artificial intelligence, and fostering its industry-wide adoption. With advances in automation and predictive modeling leading the way, a fully connected, highly efficient production system is no longer just an aspiration—it’s the future of biologics manufacturing. HIMANSHU GADGIL CEO Enzene Biosciences Ltd ENZENE
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