Day 7 – Tergus Pharma: Regulations Galore

Liya and I spent time with the IVRT (in vitro release testing) group today. Unlike yesterday’s work, we did not deal with any skin tissue or mimic precise biological human conditions. Instead, we looked at product quality and the release capabilities – specifically, uniformity between test trials. Our morning was spent with the group leader Craig, who gave us general information about IVRT, and Akeen, the scientist who showed us the dosing trials which have many similarities to the IVPT group. Both use vertical Franz diffusion cells, but instead of skin, IVRT uses a synthetic membrane (see pic below) and applies cream in accordance with surface area over exact quantities. The testing period is also much shorter (6 hrs. instead of 72). During the waiting period, Liya and I got to ask questions to Janet and Meredith who were also in the room. From conversation, they gave pointers on job trajectory and finding the right area for us. Basically, I learned that “adulting” is complicated haha.

After lunch, we met up with Meredith again who explained her work with HPLC (high pressure liquid chromatographers). For patient confidentiality, we didn’t see her work in action, but again, we spent a lot of time with questionings. At this time, Ms. Allen visited us! We spent the last part of the day talking about our two weeks and the new things we’ve been learning. Before we checked out, we met one last time with Craig who gave more details about FDA regulations, the reasons for high drug pricings, and lots on the legal elements to patents, reproducibility,  and steps to manufacturing.

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