It's About the Science
by Timothy S. Oostdyk, Ph.D., President, Eurofins Lancaster Laboratories; Sr. Vice President, Eurofins BioPharma Product Testing Group
In 2015, I marked my 30th year with Eurofins Lancaster Laboratories. It’s been a great 30 years, and I continue to enjoy every aspect of serving our customers and growing our business. As I think about the evolution of our business over those years, one aspect that stands out to me is the transition from just being great at executing our clients’ laboratory methods, to being a key partner in enhancing and developing their science-all to help meet their goal of bringing better solutions to patients. Outstanding execution every day is still absolutely critical to being a great contract services provider, and it always will be, but today more than ever our customers expect and need great science as well.
Delivering great science can only be achieved with talented and committed scientists. As we’ve grown significantly over the years, our talented people have consistently been at the core of our successful client relationships, working long hours for complex projects, tackling advanced training and graduate degrees, and pursuing groundbreaking developments to deliver more successful scientific outcomes.
Our people and company culture espouse a spirit of continual learning and improvement. One way we achieve this is through comprehensive training and development. To support our employee education initiatives and to address ongoing staff growth, in 2015 we tripled the size of our dedicated Training Facility to more than 6,000 square feet. In addition to a large laboratory module for hands-on exercises, this new expansion houses several conference and computer classrooms with seating for up to 50 people, as well as space to bring in strategic vendors for specific high-level training on new and advanced technologies.
As we continue to build our talented team, approximately 350 of our US based BioPharma Team now hold a Ph.D. or Master’s degree. And we have a lot of exciting scientific developments being pursued, with some examples presented below:
Our Biochemistry Team is active in many different areas of development, including the following:
- Research on biosimilars was recently presented at CASSS MS in Brooklyn
- Studies performed on Intact Mass Analysis and light/heavy chain and three-part subunit analysis using the Fabricator enzyme
- Investigation in heat-accelerated stress on Adalimumab and attempting to identify acid and base degradants observed in Imaged Capillary Isoelectric Focusing (icIEF) and Capillary Electrophoresis (CE) experiments, using peptide mapping, intact mass analysis, and ion exchange chromatography
- Peptide mapping experiments on Adalimumab and Avastin to demonstrate sequence coverage, sequence variance, disulfide mapping, and post translational modifications
- Involvement in a NIST collaborative Glycan study of a reference monoclonal antibody
- Performing experiments on a MALDI TOF/TOF MS to investigate N-Linked glycans using a simpler and more rapid approach
The goal of all of these studies is to gain an understanding of the structure, develop platform methods, and generate data that can be presented to potential clients.
Our Extractables and Leachables Team is investigating accelerated verses real-time aging of bioprocess bag films to determine if accelerated aging is an accurate prediction of real-time leachables profiles. These studies will help us as we guide our clients and develop protocols that yield accurate information about disposables and other materials.
Our Cell and Molecular Biology Services Team has a proven track record in successfully developing and executing qPCR, ELISA and cell based potency assays intended for product release, characterization, and stability studies. Our success in these areas is due to the efforts of our team of expert scientists as well as a rigorous training program, and this team has now grown to more than 80 people housed in our Lancaster and Munich sites. Recently the department in Lancaster established a dedicated Assay Development Team consisting of Ph.D. scientists with extensive knowledge and hands-on experience in cell line engineering, biopharmaceutical product development, cellular signal transduction pathways, protein structure-function analysis, and state-of-the-art molecular techniques. The Assay Development Team is responsible for developing ready-to-use assays, such as the array of release and characterization assays for biosimilar products. They also provide technical consultation to assist with the optimization of challenging client methods. Importantly, the team has been tasked with identifying and anticipating industry scientific and regulatory trends and expectations to ensure that the department remains cutting edge.
Behind all this exciting science are many talented and motivated scientists. With our employee turnover at half the typical industry rate, investing long-term in our people enables us to provide our clients with both great execution and great science. And in today’s ever evolving marketplace, this is clearly what it takes to be a strategic partner with the aspiration and objective of supporting and enhancing our clients’ effectiveness in bringing better solutions to patients.