Way back when I was first starting out as a chemical engineer, I had the opportunity to meet some pioneers in the field of bioengineering. No, this time I don’t mean the medical version of bioengineering- but the biochemical types. Drs. Arnie Demain, Elmer Gaden, Art Humphrey, Danny Wang.
Back then (this is more than 50 years ago), fermentation was conducted in big vats. As were a lot of standard chemical processes. (So is/was beer and wine fermentation.) But, we were also being taught the principals of continuous operations, where we could achieve steady state operations and better control the yield and by-products.
So, when it was time to use my knowledge to design water treatment facilities, I found the activity to be pretty straight-forward. As it was for certain enzyme processes. But, it turns out those were the exceptions, not the rule. Because everything was still relying on batch processes.
Which is exactly what has set the parameters for drug production. Oh, we might have used cutting-edge science and technology to develop the new drugs- but making them? Nope. Everything still was as it was at the starting days of the industry- batch fermentation. Basically, a big vat is filled with fluid and nutrients, a few microbes, with big mixers, and occasionally with air or oxygen injection for those reactions that were aerobic.
This actually was how we made our dialysis solutions. Using 4000, 6000, or 10000 l tanks. And, dumping in kilograms of chemicals to produce the desired concentrations. Turning on the agitators and mixing the heck out of the system. Then, take a sample and make sure we had the proper concentration and purity. Which meant it was about 3 hours before we filled our first bottle or drum of the product. Obviously not the best use of time- but it did work for centuries.
But, now, folks like Johnson & Johnson, Novartis, GlaxoSmithKline (GSK), and Vertex are finally converting to continuous operation. They hope to cut their operating costs in half with this new (actually old) concept. They hope to be able to discern quality (operational yield and purity) continuously and not wait until the batch process is ended (and hope that they achieved the desired results)- and be able to modify the conditions in the reactor in real time to assure those results.
The goal is also to be better able to compete against the (lower-priced) generic versions of their drugs by adopting this technological improvement. (Of course, this change does require new approvals from the FDA- the Food and Drug Administration- since the FDA approves not only the drug, but the production techniques employed to produce the drug as part of the New Drug Approval process. But, the FDA would love to improve the overall quality and reliability of drug manufacture, so we can presume they won’t be obstreperous.)
It also means that the drug companies are going to need new expertise and skills to design, operate, and manage these newer unit operations. Plus, the newer facilities can have a much smaller footprint (which means less land acquisition and building costs), since the reactors will be continually releasing product, and not relying upon one large sized batch to produce the same quantity of product.
It’s about time that this vital industry shed it’s 19th century practices and enter the 21st.
