Continuous manufacturing (CM) is a method for manufacturing end-to-end pharmaceutical products on a single, uninterrupted production line. While batch manufacturing requires transporting, testing, and refeeding materials from one process to the next, continuous processes execute all testing, feeding, and processing inline at a single manufacturing site. The global pharma industry is slowly shifting its focus from primary care to specialty medicine and rare diseases. To modify R&D models to address and adapt to challenges associated with rare, ultra-rare, and specialty diseases, the strategy is changing from being present in a few large segments to many small segments and exploring new disease areas with high unmet needs.
• CM helps pharma companies significantly speed up the chemistry and manufacturing processes, which can cut down on the overall manufacturing timelines, especially in critical life-saving drugs.
• To date, the US Food and Drug Administration (FDA) has approved the manufacture of over 7 drugs using continuous processes, which started off from only one product less than 4 years ago. In 2020 alone, the FDA approved 4 new drugs to be manufactured using CM.
• Alongside the FDA, health authorities in Canada, Europe, Australia, Japan, Switzerland, and New Zealand have approved CM application for the production of solid oral dosage forms, indicating the growing acceptance of the technology worldwide.
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