Rutgers University in central New Jersey is equipped to make more than 1 billion prescription pills a year. Its manufacturing process is faster, cheaper and more precise than traditional methods, potentially reducing reliance on factories abroad. The technology also can be used to make drugs currently in shortage, including cancer treatments.
Why, then, isn’t this major manufacturing innovation more widespread? Most drugs are made using batch manufacturing, a laborious, multistep process that stretches across continents. Storage and shipping between stages can compromise quality. Reliance on overseas manufacturers, meanwhile, is risky: About 80% of key drug ingredients are made outside the US, predominantly in China and India, where US regulators have uncovered serious breaches of manufacturing standards.
Should China cut off pharmaceutical exports, as some policymakers have warned, the domestic stockpile of lifesaving medication would run out in a matter of weeks. Advanced manufacturing processes can help. One method, known as continuous manufacturing, can develop a new drug product in weeks — something that would take months by batch processes — all in a single facility.
The basic technology has been used for decades in other industries. Applied to pharma, it could have pronounced benefits. Quality is monitored constantly using near-infrared sensors, compared with traditional sampling of pills.
Automation limits waste, saves energy and improves accuracy, thereby lowering operating costs by up to 40% and capital expenses by 75%. The scale of potential change has been compared to the auto industry’s transition to the assembly line. Some of the world’s largest drugmakers are among the earliest adopters, including Pfizer
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