A few days ago, I received a telephone call from a retired pharmacist who has read the International Journal of Pharmaceutical Compounding ever since it began. She also keeps up her reading of Scientific American and was very excited to refer me to an article in their December 2021 issue titled "On-Demand Drug Manufacturing (subtitle - "Making Pharmaceuticals Where and When They are Needed," by Elizabeth O'Day and Mine Orlu. The article begins "What if the next time you went to your local pharmacy, rather than the pharmacist looking through aisles of pre-made drugs to fill your prescription, he or she made it to the exact dose and formulation tailored for you?" Recent advances in microfluidics and on-demand drug manufacturing are poised to make this idea a reality. I might add that the International Journal of Pharmaceutical Compounding has published a number of articles about on-demand compounding utilizing 3-D printing technologies. This Scientific American article utilizes a different approach.

Producing drugs as needed at a single site means that drugs can be made in remote locations or in field hospitals. It also means fewer resources are needed to store and transport drugs and the doses can be tailored to individual patients.

The article reports that in 2016, Massachusetts Institute of Technology (MIT) researchers working with DARPA (Defense Advanced Research Projects Agency) demonstrated it was possible to make on-demand drugs. In this project, they created a refrigerator-size machine that used continuous flow to make on-demand drugs for four common drugs including: diphenhydramine hydrochloride, fluoxetine hydrochloride, and lidocaine hydrochloride: they made 1000 doses of each drug within 24 hours.

A company, On-Demand Pharmaceuticals, is actually now commercializing the original MIT work with several platforms available or in development, including American Made Precursors on Demand (AMPoD), enabling full drug product manufacturing from precursor to final formulation, and "Biomod," which enables the manufacturing of biologics and intravenous medications on demand producing sterile injectables. A number of pharma manufacturers, including Lilly J&J, Novartis, Pfizer, and Vertex, are also making use of continuous manufacturing technology at least for parts of their manufacturing processes.

Currently, portable machines for on-demand drug manufacturing costs millions of dollars, thus preventing widespread rollout. New methods of quality assurance and quality control will also be needed to regulate both personalization of formulas and single person drug batches. It's anticipated that as the cost goes down and regulatory frameworks eventually catch up with on-demand technology, this may revolutionize where, when, and how drugs are made.

(Editor's note: Pharmacists currently involved in compounding and keeping up at the front edge of the development curve may be in an ideal position to take advantage of this new technology.)

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition