Pharma is big business, but what it’s not generally recognized is, in large part, a Manufacturing business with complex supply chains, finicky chemical processes and products that have to meet stringent quality controls. Few of those outside the industry think about how drugs are made safely, efficiently and at scale with reliable quality and in precisely measured doses.
Even more interesting is the simple fact that pharma often produces sophisticated drugs using Manufacturing processes that are decades out of date, and which are being phased out in comparable industries, such as chemical manufacturing.
Drugs are typically produced with a batch process, with involves mixing compounds in large vats, followed by long delays to measure the quality of each intermediate product, and then moving to another step, sometimes in another facility. Machinery is not used continuously. Information about conditions, status, and quality is often distributed in a wide variety of separate systems. Some critical data is still gathered and stored in paper-based logs.
Manufacturing would be more efficient if it were continuous and used in everything from automobiles to the chemical industry, where compounds move through the plant without stopping, being tested and measured along the way—which plays to the strengths of IoT. Continuous manufacturing can also respond more flexibly to demand. If more is needed, you can just run the process for longer to incrementally increase product, while increasing amounts with batch require starting an entirely new batch, with all the delays and possibilities of oversupply that implies.
Unfortunately, the route to modernized manufacturing processes in pharma is not a straightforward one.
Given the possible consequences of errors in drug manufacturing, pharmaceuticals are heavily regulated. These regulations have helped delayed manufacturing processes—and will now be driving change.
When the Food and Drug Administration (FDA) approves a drug, it’s not just the active compound that is part of the approval. The details of the manufacturing process itself–down to plant layout–are included. Any change in the process requires explicit regulatory approval with attendant paperwork. In other industries, continuous process improvements, with faster access to inventory here and a step eliminated there, are part of a company’s competitive advantage. Pharma manufacturing transformation requires significantly more planning.
The FDA has recognized the inherent regulatory difficulties and formed the Emerging Technology Team (ETT) with the goal of encouraging the adoption of new manufacturing methods, particularly continuous manufacturing. The intention is that they will meet with pharma companies early in development, before any regulatory submission. Any proposed manufacturing process will be extensively vetted prior to submission for approval.
