Tag: 18HernL

For our last day at Tergus Pharma, Liya and I were with the Analytical R&D team. Their group uses analytical method development to test topicals and semi-solid dosage forms. For most of the day, we were with Praneetha who gave us a full run down on what she does with the HPLC’s. Before she used the machine, we watched as she made a sample that tests a gel substance. After calibrating the scales (it can go to the 100,000 thousandths place!) and massing the amount of the gel, she made the solution. Even though the gel was miscible in water, she still had to use sonicators, centrifuges, vortexers, and tons of shaking to make sure the solution was entirely homogenized. This process alone took over 2 hrs, much of which was waiting.

After lunch, we got a demo of more HPLC work and the multistep process for all testing. We met more people (Ravi, Ranjita, Ranbabu, and Andy) who taught us more about their methodologies as well. From everyone in the analytics team and those I met this past week, I think the big takeaway is the huge importance of documentation. Everyone said, “If you didn’t write it down, it never happened.” I never realized that the pharma industry requires incredibly precise and thorough detail.

At the end of the day, we briefly met Vijendra Nalamothu, the CEO of Tergus Pharma, and had the pleasure to speak with him about our experience. This week has been jam packed with new material, but I had fun learning details about pharma. Some details were too esoteric to comprehend, but the team did a great job simplifying everything in ways Liya and I could understand. I’m really grateful that each branch (formulation, IVPT, IVRT, and analytics) took a day to show us their work. Additionally, thanks to Duffy and Wendy who organized this experience for us!

 

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.

Yay to new stuff! Liya and I worked with Monica and Brandon, two members of the IVPT (in vitro permeation testing) team. They test a drug’s potency and efficiency in penetrating through the multiple layers of our skin. Today, using skin tissue from donor cadavers, Brandon and Monica were comparing a marketed brand-name drug vs. a client’s proposed generic version. After soaking the excised skin in various solutions to preserve the living enzymes, vertical diffusion cells were used to mimic the way our skin and blood interact. A piece of the skin covers each jar which is filled with a solution, and a small dosage is applied to the skin. As the drug seeps through the skin, the drug mixes with solution which they measure in 4 hr. increments for 72 hrs!

The process wasn’t overly complex, but the procedure was incredibly meticulous. The skin had to be kept at an exact temp while each step needed to be written down with an explanation for each deviance from the guidelines. When the dosing steps begin, an auditor needed to be present to confirm that the work is in line with FDA regulations. We learned a lot about FDA guidelines such as Good Laboratory Practice (GLP) and the implications of improper logging.

Afterwards, we met with another lab member, Lynn who worked with the mass spectrometer and liquid chromatographers. For one sample, she had to extract the solution in a dark room because the chemical was light-sensitive. Not gonna lie, many parts really went over my head, and the learning curve for the programs and aspects of the analysis is really steep. However, I’m glad I got to observe Lynn’s work because I learned a lot more about LC/MS functions.

In the second week, Liya and I will be at Tergus Pharma, a pharmaceutical company that focuses on topical treatments, for our internship experience. Today was a pretty basic day on introductions and background info on the company (a lot of new names and people!). After arriving at 9, we met Duffy McDonald and Wendy Ward, the human resources team who will be helping us throughout this week, as well as Devi Nalamothu, co-owner of Tergus.

Later, we were introduced to Chris and Michael, the people in charge of operations and facilities. Chris gave us a tour of the building and rundown on safety protocols. After the tour, Avinash, the business consultant, gave us a presentation on the business models and procedural steps to the manufacturing/production of various drugs. By the way, the FDA is kinda a big deal and plays a major role in determining the success of any drug/food item in the market. It”s wild how quick they can shut down multiple years worth of data and research! Anyways, we learned that Tergus assists in the development and initial phases of topical treatments. They go by a model of quality by design (QbD), a process that begins with clear, defined objectives and uses sound science as a basis of all experimentation. It was pretty cool!

After lunch, we met a scientist, Shrikanth Manne, who taught us the various ways active ingredients are used in topicals (ointments, creams, gels, etc.). He gave us a demo – making a hydrogel like the ones used in hair gels! Using stirrers to homogenize the wet ingredients (water and glycerin), Shrikanth then added the gelling agent and sodium hydroxide to thicken the substance into the goopy, sticky consistency found in many products in the market today. Although it was short since we didn’t have much time, I thought the process from individual ingredients to the final product was really awesome to see.

 

For our last day at IPS, Liya and I learned more about the urine testing, hemp oil bottling, and data organization. Like the previous days, we spent the mornings with Dr. Sean who did another mass spect test using highly concentrated hemp oil – a viscous, black gel that smelled exactly like marijuana*. Then again, hemp and marijuana smell similar since they do come from the same plant. Anyways, Sean did the same dilution series with one more diluted set to test for the chemical concentrations and potency. I was really impressed when seeing his data later that day because his work was incredibly precise, only 3/10,000^ths off of a flawless trial! Watching the mass spectrometer in action is always pretty nifty.

Since Dr. Taylor came in on Wednesday, Liya nor I expected to see him again today, but it was a pleasant surprise when he entered! We got to talk again and reflect on our week at IPS. He took us to Ashleigh afterwards, who showed us more details about the urine testing and the various parts of the process that we did not see earlier. I was wowed by the efficiency and effectiveness of the lab team at ILS. The lab team which is comprised of three scientists and a communications director had over 107 urine samples to analyze this week and were cranking them out quickly!

After lunch, Liya and I met with Stephanie, the lady who oversees Hemp Farmacy. As we helped her sticker more hemp oil bottles, she explained details regarding the different cannabinoids in the market as well as the various vendors that they work with. I enjoyed learning about the business/marketing elements – specifically, the way Integrated Pain Solutions, Integrated Lab Solutions, and Integrated Hemp Solutions work together. Although they act as separate businesses, they share the same facilities and blend both analytical chemistry and business models to create Integrated Solutions.

I thoroughly enjoyed my experience at IPS and my time with the employees who work there. Big thanks to Dr. Sean, Krystal, Ashleigh, Rachel, and Dr. Taylor for making my experience at IPS so exciting!

 

*No one got high in the making of this blog

Alas, Liya and I drive another long ways out to our destination of hemp and cannabinoids. Things picked up when we entered IPS today and met up with Sean in the morning to analyze the data from yesterday. Studying the linear regression models, we used the data to compile a report on the levels of CBD, CBDA, THC, and THCA in the oven-baked flowers and hemp oil. Afterwards, we returned to the lab area to clean the mass spectrometer. Sean removed the pressurizer can cleaned the surfaces with alcohol. Additionally, he used a sonicator to remove the ions and other impurities from small metal pieces. Liya and I had some free time afterwards as we waited for lunch. During the time, we read stories and watched videos of people who advocate for the benefits of CBD. It was pretty awesome seeing how many people improved their sleep, anxiety, opioid addictions, etc. from these products.

As lunch rolls around, the lab team decided to get food from a nice Thai eatery which we brought back to IPS, but the restaurant forgot to give us our fried bananas for dessert! This ended up working out because I brought a dark chocolate pound cake as a thank you gift for the lab group. Since Krystle wouldn’t be there on Friday, Liya and I thought a dessert would hopefully be a way we could show our appreciation. As we ate our Thai food and chocolate cake (strange combo honestly), we also got to talk about the history and background of Integrated Lab Solutions (ILS), a subset of Integrated Solutions. It turned into an extended lunch break but was time well spent. Not only did I learn more about the laboratories, I also learned more about the individual scientists and employees! They are all really nice, smart individuals!

After we finished our share of spicy chicken and crab rangoons, Krystle showed us their urine test operations. Fun fact: don’t try to dilute your pee when you go to the doctor’s office for a test. Apparently, a lot of people try to do that! We learned that the HPLC machines can easily detect the purposeful dilution and whatever the person may try to hide, so be honest haha! For confidentiality reasons, we were unable to analyze or study the urine testing in detail, but the general info was still quite interesting! Can’t wait for our final day tomorrow!

 

Our second day was packed with activities! Upon arrival, Liya and I met Dr. Taylor, the founder and president of Integrated Pain Solutions. We had the opportunity to sit with him and ask as many questions as we wanted. After spending over an hour speaking with him, both Liya and I learned a lot – not just about his business and his story but also about the importance of discovery throughout our college process and future career endeavors.

We were later introduced to two other scientists, Krystle and Ashleigh, who were working on urine samples in the labs. Coming from Memorial Day Weekend, they were extremely busy yet spent time showing us the procedural work and, again, answering many questions we had.

Although observing their work was educational, my favorite part of the day was the hands on experience in the lab with hemp flowers. Dr. Sean guided us through the lab procedures and taught us how they isolate the CBD and THC compounds. We used several chemicals, centrifuges, vortex machines, pipets, and a tandem mass spectrometer to study these compounds in the flowers and hemp oil. As we watched the machine warm up, Sean explained the various components of the device from the remove computer controls to the highly pressurized gas chamber. We were unable to analyze the results since we ran out of time at the end of the day, but tomorrow, we will resume our work and learn how to analyze the data.

It was somewhat exhausting to learn all the new information, yet studying hemp and the various cannabinoids is a fascinating field and an unparalleled experience that has taught me so much more about pain solutions. With what I learned today, I am excited for our next two days at IPS and learning more about mass spectrometry!

Today, Liya and I arrived at Integrated Pain Solutions (IPS) located in Southern Pines. For the first week of WEP, we will be at IPS, studying hemp products as an alternate medicine for various issues such as pain, inflammation, or anxiety. Through a multifaceted solution to the aforementioned health issues, IPS utilizes hemp products, acupuncture, and yoga along with many other Eastern medicinal techniques to counter the rising concerns facing the Opioid Crisis across the country.

We began our day with a guided tour of the facilities and were able to interact with various scientists. The first half of the day was spent doing background research on hemp and its counterpart, marijuana, for medicinal purposes. We learned that hemp, unlike marijuana, has minute, almost nonexistent psychoactive properties and can be used in an assortment of goods, ranging from essential oils and relaxing balms to infused tea beverages and candied snacks. In the second half of the day, we bottled hemp oil and learned about the manufacturing/production of the extracts! With the help of one of the scientists, Sean, we were able to learn about the work behind the scenes. It was an insightful first day, and we are excited for what’s to come!