ENZENE Decades ago, microchips were a luxury— expensive, rare, and reserved for only the most specialised applications. The cost was high, making them inaccessible for widespread use. But as manufacturing techniques improved and economies of scale took effect, prices dropped dramatically. This shift fuelled an explosion of innovation, making computing power ubiquitous. From bulky mainframes to the smartphone in your pocket, the relentless drive to refine and optimise the microchip has transformed every aspect of modern life. A similar transformation is now underway in biologics manufacturing. For years, biopharmaceutical production has been dominated by batch-based methods, where each stage of production is completed in isolation before moving to the next. This method, while reliable, has long been plagued by inefficiencies—delays between processes, complex quality control measures, and massive facility requirements. Perfusion technology, introduced in the 1980s, promised a more continuous approach, but the production times were too long, and yields were too low to justify widespread adoption. But just as advances in microchip size and manufacturing unlocked new possibilities in computing, breakthroughs in cell line engineering, process automation, and real-time monitoring have revolutionised biologics production. Fast forward to today, and the landscape has shifted dramatically. Continuous Manufacturing (CM) enhances yields, reduces costs, and streamlines production. However, a lot of companies have different technologies that they adopt for continuous production. Some may use upstream perfusion that is then connected to the downstream processes in sequence while some may retrofit continuous components into their existing batch processes, creating a hybrid system. A few achieve a fully connected, end-to-end process. True CM integrates upstream and downstream operations without interruptions, compounding efficiency gains that go beyond perfusion alone. Enzene’s fully-connected continuous manufacturing™ (FCCM™) for biologics is one such example - an end-to-end continuous platform which can produce high volumes, around 40-50 kg of product from a 1000-liter bioreactor within approximately 30 days, depending on the molecule and titer. TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 70
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