Standards Observed as an Intern at Regeneron Pharmaceuticals

The entire pharmaceutical industry is governed by standards set by the FDA and other regulatory agencies. Processes from drug discovery to commercial manufacturing, and everything in between, are carefully observed and supervised. While these standards were not directly apparent to me during my daily work, I was well aware of other standards. My responsibilities as an intern were essentially a set of standards that I was required to follow in order to best perform my job. I worked in an early-stage cell culture group in the pre-clinical manufacturing and process development division of Regeneron Pharmaceuticals. The cell culture group that I worked with had developed a “speed to clinic” approach for evaluating drug candidates. The process that we carried out on a daily basis was a set of numerous standards that were combined together to create a “platform” process. This process was carried each time project management gave us a new drug candidate to evaluate. With each new drug candidate we were given data from protein expression sciences. The data was a standard to which we expected the drug to perform. We monitored nutrient levels and protein production for each drug candidate and did our best to achieve results close to the original data. We held weekly meetings were we discussed and observed various profiles for the candidates. The two main profiles that we were interested in looking at were titer (protein) and viable cell count. These two profiles became the standard for us to observe. If we noticed anything unusual about either of these two profiles, we would investigate other profiles to look for possible answers to any abnormalities.

There were also many standards within the laboratory. During the first week that I started working at Regeneron, I underwent many training courses demonstrating common lab practices. It was necessary for everyone to share common practices because sterility is very important in dealing with biological specimens. Without proper sterilization, cell culture will contaminate due to unwanted bacteria. I learned sterile techniques for working in the hood, as well as, methods for transferring cell culture from one vessel to another vessel while maintaining sterility. We had a specific formula for making nutrient feed for the cells and there was a well-defined set of standards for how this should be done. The order in which the components were added and sterilizing the nutrient feed were all things that needed to be taken into consideration. Setting up a production bioreactor also had a set of standards associated with it. The head-plate of each glass vessel contained various ports and lines that each had a different function. Each person in the cell culture group followed the same protocol for setting up a bioreactor. This was important because we all used the same bioreactors for our experiments and we frequently helped perform each other’s work.

The purpose of these standards is to create an efficient “speed to clinic” process and to maintain a laboratory environment that encourages proper sterile technique, as well as, co-worker collaboration. Without these well-established standards in place, it would have been ever difficult for me to perform my job and effectively help my co-workers.