The Future of Pharmaceutical Manufacturing and How it Will Impact EH&S

Highly potent compound manufacturingRecently I was reading an article in Technology Review Magazine about “The Future of Pharma Is Incredibly Fast“, and I wondered about the positive impact that this will have on environmental, health and safety issues. In this article, Susan Young, briefly discusses a presentation by the CEO of Novartis, Joseph Jimenez, on how pharmaceutical products are currently produced in a batch by batch method. As all life science environmental, health and safety experts and professionals know, this method of production is extremely inefficient. This method generally requires the synthesis of the active pharmaceutical ingredient and excipients in multiple locations. These locations may be in several different countries, thus requiring time consuming and costly transportation to where the final tablet or capsule is formulated. Once the raw materials arrive at the final manufacturing site, numerous quality issues arise to ensure that all raw materials meet quality specifications.  The final formulation process generally requires multiple transfers of materials, which each have the potential to cause occupational exposure to active pharmaceutical ingredients, or environmental concerns.

If the vision of the Future of Pharma Manufacturing, as presented by Jimenez, comes to fruition, this will present a significant opportunity for environmental, health and safety professionals to become engaged in the process and engineer out many of the occupational exposure issues that we experience today. I would anticipate that in the next fifteen years or so, that the way we will make solid-dose oral pharmaceuticals will be significantly different than what we are experiencing today.

 


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About Dean Calhoun

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Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

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