Tergus Day 4

We worked with one final department today–the Analytics department. These teams verify the methods that are given by clients or created in-house at Tergus. They do this by following the listed steps on a method while changing a few parameters ever so slightly. If the method is satisfactory, then it should hold up under the stress testing. We firsthand saw the precision at play–for example, the scale goes up to an amazing 5 decimal points! On the other hand, we witnessed the specific chemicals that were used for the lab setup. For example, acetonitrile, or ACN, was used to break down the gel of the topical solution that was being tested. That way, the molecules of the active ingredient would better distribute themselves throughout the mixture.

We were also given a walkthrough of the HPLC, or the high-performance liquid chromatography technology. This piece of equipment allows seperation of each component in the prepared mixture. When the active ingredient passes through the micron-sized column, it should create a specific peak at a certain time point on a graph. If the retention time of the peak matches that of the predicted peak, then the method is good to go.

I learned a lot at Tergus this week and had tons of fun working with Tergus’s lab technicians.

HPLC Columns

Week 2, Day 3: IVRT and mEmBrAnEs

Today, I spent time learning how IVRT works at Tergus Pharma. I observed how they dose ointments, gels, and cremes into the dosing chamber and also how they sample the doses (by shadowing Emeel). We learned about the regular intervals in which the sample doses. We later learned about HPLC (high-performance liquid chromatography) and we watched Adam making the mobile phases. We didn’t have time to actually run the chromatography, but we plan on doing that tomorrow if we have time.

One really cool thing we learned today was that all of the lab’s data is uploaded in real time to a place where it cannot be deleted. Then, later, the FDA has access to all of the results. Because of this, the scientists and lab techs double and triple check their methods before they run them in an HPLC or LCMS because otherwise, they could be subject to an investigation if something was messed up and not fixed.

 

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