Given the cost of regulatory approval, it is more likely that the project could enable patients to “home brew” their own diabetic treatments. There is currently no structure for regulating drugs that are not produced commercially. One report estimates that as many as 2,000 patients have already reverse engineered their own insulin pumps and electronic monitoring systems. The insulin itself could be next.
Is it possible to make biologic drugs like insulin more affordable without compromising safety? One suggestion that has been gaining steam is to scale down biomanufacturing. Right now, biologic medicines like insulin are cooked up in giant batches. Ensuring that those batches are consistent and free of contamination is a major challenge.
Think about the meat department in your grocery store. Many big-box stores stock hamburger that was ground in a central processing plant and then distributed. If an E. coli outbreak occurs in the plant, it’s going to spread to all of the stores downstream, potentially infecting hundreds or thousands of people.
The meat is also exposed to more potential contamination events through storage and transport. And, if contaminated meat is identified in one store, it won’t be immediately clear whether or not all the others are safe.
Now, consider a small local butcher who grinds meat in-house. Any safety risk is going to be isolated to the customers of that one store and the source will be obvious.
Similarly, producing medications in smaller batches reduces the potential impact of any one safety event. Pharmacy compounding provides an example. In compounding, drugs are specially mixed or produced for a very small number of patients. Compounded medications are not subject to clinical trials.
If insulin were made in smaller batches, manufacturers might be able to forego clinical trials and use simpler and less expensive tests to confirm that each batch of insulin produced is safe and comparable to previously approved insulins. It would be like using chemical tests to identify important flavor compounds in two vintages of wine instead of organizing taste tests. This model could also apply to other expensive biologic drugs such as those that treat cancer, HIV and rheumatoid arthritis.