Making a drug is a bit like baking — in the goopiest, messiest sense possible. Just ask Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research.
“We take the [inactive] and active [ingredients] and put them into a giant pot. It looks like a gigantic cake mixer. And then we … take that mush and we squeeze it out into a string and put it into tablets,” said Woodcock. “It’s a mess, it gets all over the place.”
She added, “25 years from now, we’re going to look back and ask ourselves, ‘What were we doing?”’
Blending of solids and liquids has been practiced to suit application and use needs. That is fundamental chemical engineering. I have no clue what Jonathan is talking about. It has been perfected and advanced in every industry except for pharmaceuticals. Thus to me and many others it is no innovation. May be to pharmaceutical industry and regulators it is new as they seem to be living in Stone Age.
While I applaud the enthusiasm of the author, the time frame is a bit off. “One challenge is that, to make drugs continuously, companies also need to ensure drug quality continuously.” This line reflects PAT (Process Analytic Technology) which is something the FDA was pushing industry toward around 2005 – because it would make ‘Continuous process’ possible. This has been in the pipeline for a long time – finally coming to fruition. (And to show my NJ bias, with a great deal of work done at Rutgers School of Engineering in this area, as well as NJIT.)
Note the date of this article if you chose to read it: https://ored.rutgers.edu/content/fda-awards-49-million-rutgers-led-research-consortium-expand-continuous-manufacturing
Formulations could have gone continuous 60+ years ago. They have not. Why? No desire to innovate as poor practices make money as patients will pay to extend life. Linked might be of interest. https://pharmachemicalscoatings.blogspot.com/2017/07/batch-continuous-or-fakefalse.html?m=1
Girish, an amazing coincidence of timing between your article and this one. And your point is well put.
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