Author: estellam604

Today my meeting with Mrs. Yates didn’t have a specific purpose because the test results she is waiting to show me do not come out until Thursday. Instead, we just met briefly and discussed some general information about vaccines and the pharmaceuticals industry.

https://theconversation.com/the-most-powerful-companies-youve-never-heard-of-merck-3187

She told me that Merck, which has buildings and labs located in Durham, currently produces Varicella, Shingrix, MMR, and Gardasil. Varicella is the chicken pox vaccine, Shingrix is the vaccine for the new strain of shingles, the MMR vaccine is the vaccine against measles, mumps, and rubella, and Gardasil is a new vaccine for HPV.

They only recently began producing Gardasil because it has been more popular on the market since it was recently approved for males. Previously it was only offered to females in two doses, once at 11 and again at 14. Now the clinical trials are complete and it is on the market for boys too.

Another thing I learned is that it is very common in pharmaceuticals for a drug created for one cause to end up being used for another cause. For example, Merck is the only facility in the world that makes Bacillus of Calmette and Guerin or BCG. BCG is a vaccine for a strain of Mycobacterium bovis that was approved for tuberculosis about 30 years ago. Today, doctors have found that it can cure bladder cancer if administered to bladder cancer patients. This is an amazing discovery that can save lives, but is more common that I thought. Another example is Viagra which was originally developed as a blood pressure drug, but during testing and clinical trials, male patients found that it treated erectile dysfunction. Now Viagra is solely marked as a drug for erectile dysfunction.

Merck is also converting a wing of a lab that produces Varicella into a place where they can make the Johnson and Johnson COVID-19 vaccine. Because of the low demand for Varicella and the high demand for COVID vaccines, the company has formed a strategic partnership with J&J and will begin manufacturing vaccines as soon as renovations are complete. A fun fact about the COVID vaccine: it has to be refrigerated at temperature as low as -70 degrees because it is an RNA vaccine and RNA is much more unstable of a structure than DNA, which can survive in regular refrigerated temperatures.

Today I met with Mrs. Jill Yates from ValSource. Valsource is a company that tests and verifies equipment used for manufacturing drugs for companies that hire them, like Merck or Biogen. Mrs. Yates has personally been working for ValSource as a contracted resource for Merck since 2009.

https://www.merck.com/research-and-products/

Unfortunately, due to some new guidelines from Merck, I am not allowed into the facility and can only meet with Mrs. Yates virtually. To prepare for our fist meeting Mrs. Yates sent me some models and test manuals of two incubators, the IMP180 and the Milliflex Quantum Reader, that her company will be testing on June 1st and 2nd. She asked me to do some research and answer the following questions, which we discussed today:

1. What do you think these are used for?
2. To qualify these systems, and show they are fit for use, what kind of testing would you do?
3. What more would you like to learn about these systems?
4. What other questions do you have about the pharmaceutical industry in general?

For a brief summary of what we talked about, the IMP180 is a type of refrigerated incubator used for tempering (cooling and heating) defined substances and materials. It is not used to process harmful chemical substances or substances that are easily flammable/explosive, poisonous, release dust, or exhibit exothermic (heat releasing) reactions. They serve for the preparation and cultivation of cell and tissue cultures and employ precision temperature control for simulating the particular physiological environment for these cultures to grow in.

The Milliflex Quantum Reader is used for reading microbiological media plates using fluorescent-based technology to detect microorganisms. This basically means that you put a media plate in the incubator and when it comes out the colonies will be marked with a fluorescent dye to make them easier to see.

Below is an example of how the incubator making colonies easier to see:

https://www.americanpharmaceuticalreview.com/Featured-Articles/151950-Milliflex-sup-sup-Quantum-Detection-of-Microbial-Contaminants-in-Water-Samples/

A fun fact that I learned today is that manufacturing vaccines is a more biologically focused process while manufacturing tablets and pills is a more chemically focused process because it requires more thought about how the body will react with the active ingredients inside the pill.

To end our meeting, I asked Mrs. Yates some general questions about her career and some of the academic achievements she needed to get to where she is today. She told me that because she studied at a small university, she majored in biology with a minor in chemistry, but would have chosen a more specific degree if her school has offered it. She suggested that I start broad with the major I am interested in and work towards a more focused degree that I find myself gravitating towards if my university offers it. The most important point that she continued to reiterate is that the reason she got a job with ValSource in the first place is because of the internship she got in college with a local lab company. She said that it helped her get lab experience while she was still in school and the firm offered her a job in their labs once she graduated, which gave her the qualifications and experience she needed to eventually move up the ranks with different lab companies until she found ValSource.