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 Inc., Eli Lilly & Co. and GSK Plc. Johnson & Johnson invested millions of dollars in the continuous manufacturing lab at Rutgers. Other companies exploring advanced techniques include the Mark Cuban Cost Plus Drug Company, whose Texas facility can pivot from one drug type to another in a matter of hours, according to recent testimony to Congress by its chief executive officer.
BloombergDespite these early efforts, barriers to broader adoption of continuous manufacturing remain. Upfront costs for new equipment are high, prohibitively so for the low-margin generics currently in shortage. Meanwhile, companies that have invested in batch manufacturing for existing drugs are reluctant to switch. Any change in process must be approved not only by the Food and Drug Administration, but potentially dozens of regulators around the globe, which introduces delays and uncertainty.
BloombergCould the government do more to speed this transition?For starters, the FDA could take more action to earn the industry’s trust. The agency supports continuous manufacturing and generally approves such processes more quickly than the traditional kind. Yet drugmakers still cite the prospect of costly delays as a chief deterrent. The FDA should accelerate the application process by eliminating duplicative reviews for minor changes and establishing site-based, rather than product-by-product, approvals for advanced facilities. It should also reduce inefficiencies during the review process and better align with global regulators on approvals. Such measures would go a long way toward gaining the buy-in of senior management, which tends to prioritise research and development over manufacturing investment.As for Congress, it should revive a bill to establish so-called centers of excellence, like the one at Rutgers, nationwide. In addition to training workers and conducting basic research, such institutions would give manufacturers of generics and smaller branded drugs access to expertise and production capabilities unavailable in-house. Allowing companies to deduct R&D costs immediately — a once-standard practice that Congress has now inadvertently outlawed — would also boost innovation and investment in the field.Continuous manufacturing won’t make sense for every pharma company or drug product. It could revolutionise the industry all the same. Policymakers should ensure they aren’t standing in the way of progress.
