Developing Robust Potency Assays for Validation: A Case Study

Peter Wunderli, Ph.D., associate director, bioPharmaceutical services,PPD, cGMP laboratory

As associate director of the cell lab for PPD’s cGMP labs in Middleton, WI, Peter Wunderli manages a team of scientists and provides oversight and review of method development and validation and stability testing projects. He works with clients on proposals, contracts, laboratory investigation reports and final project reports.

Before joining PPD, Wunderli began work as a bench scientist developing blood borne pathogen screening assays as commercial products, with his responsibility growing to senior management roles across several companies, and involving the development of vaccines and biotherapeutic products. He has had roles across a variety of functions, including R&D, regulatory affairs, quality, and operations. With more than more than twenty-five years of experience at the bench and managing groups involved in developing a wide range of product and response testing methods and models, Wunderli has extensive experience in support of the development, validation and manufacture of assays and products in the fields of infectious disease, cancer, and endocrinology. These methods have been successfully applied for GMP/ISO; GLP research and clinical; and commercial IVD applications, and he has authored and/or managed assembly of submissions for IND applications, 501(k)s, and product registration and licensing in the US and Canada.

Wunderli earned a Ph.D. in medical microbiology from the University of Georgia-Athens, a master’s degree in microbiology from the University of Illinois-Urbana, and a bachelor’s degree in microbiology from the University of New Hampshire-Durham. His publication and presentations demonstrate a wide range of expertise with relevance to his multiple therapeutic and diagnostic areas, and he has applied his knowledge as a consultant to several companies involved in both drug development and diagnostics.