Get Yourself Connected

There’s a cinematic subgenre I like to call “Everything’s connected”. It’s perhapsbest exemplified by Robert Altman’s classic “Nashville”, where charactersinhabiting one location are in the background of some scenes and the foregroundof others. Things minor characters do or say in one scene may affect characters inanother—even if they never actually interact. A more “pop” example? The “MarvelCinematic Universe”, where a superhero serving a minor role in one movie playsthe lead in another—and then is one of many “Avengers” in yet another.

This phenomenon is relevant to this particular issue, because, as the articles camein, I found some interactions between them—both anticipated and unsuspected.For example, if one chooses to take a “continuous manufacturing approach” witha particular product, that will a ect what excipient one chooses, as well as how theproduction line is arranged. Meanwhile, one’s regulatory concerns must also shiftand expand, since new issues like microplastics monitoring in medicinal productsbecomes more prominent, and impacts formulation considerations.

In one respect, this could be considered a now cliched admonition about thedangers of the over-used term “silos”. But that is, perhaps, an oversimplification.One needs expertise at each point of the drug development and manufacturingprocess—in other words, a mastery of what goes on in each silo. But one alsoneeds to understand how those silos are inter-connected. It’s a tough balancingact, akin to a director juggling multiple subplots and major and minor characters,shifting them from foreground to background. But mastering it results in a betterpicture, if you’re a director, and product, if you are a drug manufacturer. 

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