A Tectonic Change in Pharma?

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On-Demand Phamaceutical Manufacturing

On Monday, the Defense Department announced a $20 million contract to On Demand Pharmaceuticals, to further develop machines that can produce drugs at the point of care. ODP’s miniature drug factories are built on research first funded in 2016 by the Battlefield Medicine project of the Defense Advanced Research Projects Agency. DARPA’s goal was to create a drug-making machine that could be shipped to harsh environments and mix medicines on demand for a wide variety of illnesses or conditions.

“It can often take weeks to months to manufacture and airlift organic pharmaceuticals and protein therapeutics to battlefield frontlines, meaning that critical medical supplies often do not arrive in time where they are needed most.” r

ODP’s device continuous flow chemistry to combine ingredients in a special tube or pipe, reducing the time and space needed for the multiple steps of traditional batch production. A process called continuous bioprocessing does something similar for biologics such as antibody therapeutics. ODP’s device can make both types of medicines.

“These systems make drugs from starting materials to finished product in hours instead of weeks or months,” the company claims.

Such machines may prove useful far closer to home than DARPA originally envisioned. The pandemic has underscored how dependent the United States had become on foreign companies (or enemy companies in the case of the People’s Republic of China) to supply various drugs and their components, called active pharmaceutical ingredients, or APIs. Lawmakers and others have expressed concern. “Critical APIs and their starting materials have long been sourced from overseas, and the collaboration with ODP is expected to increase the onshore production of three critical APIs that ultimately form the building blocks for final formulated medicines used to treat critically ill U.S. service members and COVID-19 patients,” notes the Monday statement from the Defense Department.

It would require scaling up the type of machines that DOD would need if the USA was to provide these machines to various domestic localities, but it would change how many therapeutics are made and distributed forever.

11 thoughts on “A Tectonic Change in Pharma?

  1. Chemical engineering has won again, continuous flow mechanics is the way to go.
    A much larger block, I think, is the requirement in the U.S.A. for a prescription (and doctor’s office visit) every time a life-long, life-sustaining drug like insulin, or various heart medications is needed.

    1. Tele-medicine will change things, but I have no idea what on-demand meds of this sort, manufactured regionally would mean to the way medical care is dispensed. What it would mean is that there would be redundant manufacturing on an as-needed basis (generally) if this sort of system were to be implemented.

      I have had the same doctor for about 35 years. We’ve aged together. The reason I like the doctor is that he draws a lot of blood and tests the heck out of me. I like seeing what those tests show over time (charts on-line). So I’m not opposed to a visit every year and tests every six months or so.

  2. Good. This will be useful not just with the military or providing domestic production of specialty drugs. This can be used… IN SPACE! or ON MARS!

    And any reason to stick it to the ChiComs is a good reason.

    Once again, playing ‘speculative funding’ through DARPA or other similar agencies have resulted in a potential life-changing (for the better) product. This, this is why we fund DARPA, NASA and other agencies.

    1. The Moon, Mars, Antarctica, and remote outposts as well as urban hells where the production can meet the demand. No more expiration dates on the shelves. That alone should save big.

  3. Long time lurker here. My day job is in pharmaceutical synthesis. While flow chemistry is certainly very cool and has some advantages over traditional batch style reactions, it is no where near robust enough to handle every type of reaction you throw at it. Point of delivery pharmaceutical synthesis is a solution in search of a problem for a few reasons.
    1) How well sourced are the precursor chemicals going into the machine. Are they shelf stable?
    2) Synthesizing a drug is really only half the battle. Once made it has to be analyzed to insure it meets specifications, and just one batch, every batch. This is NOT a trivial matter. Need proof? Read about the Zantac recall.
    3) Certain types of reactions are very amenable to automation (e.g. peptide synthesis). Other types, like metal-halogen exchange at cryogenic temperatures, a lot less so. It can be done, but by then the process is pretty much only optimized for that drug and that drug only.

    1. Thanks for commenting. I think that there are a lot of questions, particularly when it comes to precursors, then there is process as you laid out. Still, it is a worthy goal to pursue, even if only to bring the entire supply chain to the US (if that’s possible). I know that a lot of precursors are sourced outside of the US, but can we keep them in the Americas?

      1. It’s within the realm of physical possibility to keep the pharmaceutical supply within the boundaries of the US. Is it a wise business decision? The jury is still out on that.

        I would love nothing more than to see more bench chemistry come back from India and China. The average talent of our new graduates is an order of magnitude better than any recent graduate from south or east Asia. Sadly, those parts of the world really don’t give a f@#k when it comes to waste disposal and safety. Therefore every done there is monumentally cheaper. I know it’s probably racist/xenophobic to say it out loud, but most chemists simply don’t trust the results published in less impactful journals from obscure universities across Asia because it’s all garbage. Their results are not reproducible.

    2. I agree – the actual synthesis is only part of the process, and even that can be very difficult depending on what is being produced. I don’t see the on demand machines working on a wide range of drugs; there is too much difference in the processes and precursors required.
      For example, insulin is produced from genetically modified bacteria. Penicillin comes from fungus, some cancer treatments come from tree bark…. the variations are enormous.

  4. I had the privilege of having a retired Air Force flight surgeon as my doc for several years. When I left the area I ask him what did I need to do to live till I died. He said “ never go to the hospital , avoid doctors like the plague “

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