Sara Terpening provides more than 25 years of experience in biomedical research and development, specializing in development strategies, technology transfer, process development and validation, participation in regulatory meetings (e.g. pre-IND, Type C pre-clinical, Type C CMC, pre-BLA), and regulatory IND and BLA submissions. Sara’s expertise in strategic planning for biological product development programs is evidenced by the successful advanced development, from pre-clinical through Phase 3, of over 20 biological products including viral and recombinant protein vaccines, monoclonal antibodies, and therapeutics derived from blood products with two products successfully advanced to licensure in support of the U.S. Department of Defense (DoD), Department of Health and Human Services (HHS) (i.e., NIAID, BARDA) and commercial clients.
In her position as VP Science and Technology at Nanotherapeutics Inc., Sara leads efforts in product development strategies, integration of new technologies into biological production processes, technology transfer of products and processes into the Nanotherapeutics facility, as well as, transition of products from process development to cGMP manufacturing.
Prior to joining Nanotherapeutics, Sara worked at DynPort Vaccine Company (DVC) in Frederick Maryland from 2002 through 2014 as the Director of Manufacturing, Testing and Technical Services. Her responsibilities included providing technical leadership, integration of technical activities, and regulated studies compliant with the current FDA regulations and ICH guidance for product assessment, analytical method development, manufacturing process development, CGMP manufacturing, process and assay validation, product testing, quality control, and storage and distribution of biologics.
Working for the Science Applications International Corporation (SAIC) in Frederick Maryland in the Drug Mechanism Laboratory, Sara conducted research in drug development and determination of mechanism of anti-viral activity.
Sara has received a Master of Science in Technology Management, Biotechnology Track, from the University of Maryland University College and a Bachelor of Science in microbiology from the University of Michigan. She has published peer-reviewed manuscripts related to biological product and process development. In 2012 Sara earned and has maintained a Project Management Professional certification through the Project Management Institute. In addition, Sara has completed Defense Acquisition training.