Developing Robust Potency Assays for Validation: A Case Study

Drug Discovery and Development, Life Sciences, Pharmaceutical,
  • Tuesday, February 19, 2013

Cell-based assays, or bioassays, are designed to establish the potency and stability of a drug substance or product, and are important in establishing safety and efficacy profiles for biological drug products, or biopharmaceuticals. The assays are designed to demonstrate the relative potency of a product by comparing the biological response, related to its mode of action, with a control preparation (USP, WHO or in-house reference standard). These assays are applied as a component of product and process characterization/validation, and can be used to select candidates; establish comparability; test process intermediates, formulations and stability/degradation; and to support product changes. These assays must be sufficiently robust to meet international regulatory and USP guidelines for system suitability, and are applied for drug substance and drug product lot release and stability testing to support licensing for commercialization.

In this webinar, our expert shares a case study for a biological drug product that required re-development of both the bioassay method for potency, as well as an improved process for extracting the drug product from a carrier so that the potency of the final drug product could be reproducibly measured.


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.

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Who Should Attend?

VPs, Directors, Managers and Department Heads involved in Clinical Research, Development or Operations for pharmaceutical and biotechnology companies worldwide

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PPD is a global contract research organization (CRO) providing discovery, development and lifecycle management services. With offices in 46 countries and more than 12,500 employees worldwide, PPD has conducted clinical trials in more than 100 nations, and we have worked with all of the top 50 Pharmaceutical companies.

PPD is a leading provider of chemistry, manufacturing and controls (CMC) laboratory services for all phases of drug development and follows current Good Manufacturing Practices (cGMPs). Our cGMP laboratories provide fully integrated product and analytical development services ranging from early characterization through commercial release and stability. Our highly qualified cGMP lab staff works with large and small molecules, including active Pharmaceutical ingredients (API), drug products, inhaled products and other medical devices. With more than 200,000-square- feet of cGMP laboratory space, we have locations in Athlone, Ireland; Middleton, Wis.; and Wayne, Pa., to meet our clients’ needs.

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