People are the Chemistry: Dr. Kate Bergmann
At Lancaster Laboratories, we believe that our people provide our strength. Their dedication to quality, professional competence and hard work is the key element in the company’s success. In this regular feature, we introduce you to some of the people who have helped make Lancaster Laboratories an industry leader.
Dr. Kate Bergmann has grown Lancaster Labs’ Viral Safety and Viral Clearance Department tenfold since joining Lancaster Labs in 2006. Drawing from her 17 years of biologics industry experience, Dr. Bergmann has brought extensive expertise in research and CRO biosafety testing to Lancaster Labs. Previously, Dr. Bergmann was manager of process evaluation at Charles River Laboratories, where she directed viral clearance studies and coordinated projects involving idiotypic cancer vaccines. Dr. Bergmann earned her Ph.D. in biology from Brown University.
What is the scope of your work as it relates to clients?
I manage the Viral Safety and Clearance Services department. This department was created in 2008 to support testing for biopharmaceutical products. We spent a lot of time in the beginning developing and validating procedures. As we have completed development of our core assays, we are spending more of our time testing client samples. However, there are many more assays to develop!
Viral Safety testing involves testing of the products to ensure that there is no virus contamination. There is a battery of standard tests that are performed for each product, although the specific list can vary with the nature of the product. Viral Clearance testing involves evaluating the ability of the purification procedure for the product to remove virus that might be present in the starting material. In a typical Viral Clearance study, the client will move into our client labs for a period of several days to several weeks. They will set up their purification process in miniature, and we will add virus to the steps as they run them. We will then evaluate where the virus is found after the purification steps are done. Every product is different, and every Viral Clearance study is customized to the product and stage of development.
What does your current job entail?
In addition to managing the department, I talk with clients by phone and in person to clarify their needs for testing and offer solutions to specific problems. Viral Clearance projects in particular require a lot of interactions with the client to finalize the study design, schedule the project and make sure the resources are available when needed. I also assist Customer Service and Business Development in determining what services each client needs. Recently, I presented an introduction to Viral Clearance during two Technical Seminars that Lancaster Labs presented to clients in areas with a strong biopharmaceutical presence.
Given all of your responsibilities, how would you describe a typical workday?
The only feature of my job that I can count on is that whatever I am doing, I will be interrupted before I am finished. Even answering these questions took several tries before it was done. I try to keep a balance between overseeing current work, developing and validating new procedures and planning for Viral Clearance projects. My days are a mix of internal meetings, client communication, writing and reviewing. One thing is for sure – it never gets boring!
What kind of volunteer activities have you been involved with?
My husband and I participate with our church in a group called Good Works. This organization performs home repairs for needy home-owners in Coatesville, PA, which has a high poverty rate due to the closing of the Lukens steel mills that used to support it. The motto of Good Works is “Warmer, Safer, Drier.” We spend one Saturday a month doing all sorts of construction and repairs, including bathroom and kitchen replacement, walls and ceilings, windows, heating systems and sidewalks. We work in the same house for up to 18 months, and in that time we build relationships with the home-owners. We try to become part of their lives for the time we are there, and this gives us opportunities to serve them in other ways also. We always leave tired from a work day, but we feel good about the help we have provided them.
How does your group’s work impact/benefit society?
I am always motivated by the goal of ensuring that the drugs people take are safe. There are many facets to ensuring drug safety. Our part is ensuring that taking the drug won’t lead to infections caused by viruses that should not be in the drug. The quality of our work affects not only the manufacturer’s ability to bring the product to market, but also the safety of patients that will use it.
