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 I hadn’t decided how to orient this discussion today.

Over the last two decades, too many of our pharmaceutical entities have off-shored the production of generic drugs- as well as the critical components for all our drugs.  These critical components are known as API- active pharmaceutical ingredients.

And, when I was in grad school, the focus of biochemical engineering education and training was to switch production from batch mode to continuous mode.  The batch mode relied on the traditional fermenters (or modified chemical reactors called CSTR’s [continuous stirred tank reactors]), where ingredients were dumped into a tank of water, mixed, aerated, inoculated with microbes, and after a certain time (to allow for microbial growth), the product was harvested.  (Note that some products only involve chemical actions- in those cases, the ingredients did not get aeration, microbial addition, and the like- they were simply specialized chemical reactions.)

In case you forgot how old this coot is, that was about 50 years ago.  And, to date, most biochemical and pharmaceutical production is still effected in batch modes. Sure this process makes great chemicals, but its not terribly efficient.  A continuous reaction could produce product for hours/days on end, without needing the processes and reactors to be shut down, cleaned, and then restarted.  (Note also that part of the problem is that the FDA [US Food and Drug Administration] requires what they call batch approval and release.)

One of the last acts by Dr. Rick Bright (PhD Immunology and Virology [Come on.  It hasn’t been that long- this is the guy that TheDonald fired because he was doing his job well.]) of BARDA (Biomedical Advanced Research and Development Authority) effected was to award a $ 354 million contract to a start-up, Phlow.   This Richmond, Virginia firm plans to change the way critical pharmaceutical components and generics are made. (This contract is shared with AMPAC Fine Chemicals [API manufacturer based in Rancho Cordova, CA], Civica Rx [quality not-for-profit generic drug manufacturer, Lehi, UT], and VCU’s [Virginia Commonwealth University] Medicines-For-All-Institute [funded by the Gates Foundation to provide open access to manufacturers for new production techniques and concepts].)

Phlow

Instead of batch production, Phlow will be using continuous manufacturing techniques.  It will be making these vital components here- in the USA- not in India or China (there are a few elsewhere in SouthEast Asia).  So, when we need to ramp up production of certain drugs, we don’t have to wait for delivery- or worse yet, be told that we can’t get the raw materials needed because the prevailing pandemic conditions mean the country of origin is hoarding those supplies for its own needs.

                This is a Phlow video that, unfortunately, could not be embedded here.  So, I improvised.

We also expect that Phlow will be involved in the production of COVID-19 therapies.

The goal is to provide a “rapid surge: response to healthcare needs and shortages.  And, to do so at lower costs than currently obtain.”

The key factor is that both quality concerns and supply logistics will no longer preclude the US from responding to the various health care shortages.

 

 

 

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