Speaker: Ashutosh Rao, Ph.D., Center for Drug Evaluation and Research, U.S. Food and Drug Administration Topic: «Scientific and regulatory perspectives on control strategies for excipients in biotechnology drugs» Date, time: Fri May 7, 2021, 14:00 – 15 h Mode: Online Webinar, Zoom link Abstract: Surfactants and other excipients are an integral component of biotechnology drug products. Consequently, optimal formulation and control of excipients are key aspects of an overall control strategy by drug manufacturers aimed at consistent product quality, safety, and efficacy. Evolving evidence suggests that certain surfactants are susceptible to degradation and particulate formation in protein formulations; although, the root cause, biochemical drivers of degradation, and impact to the product and patient remain unresolved questions. The regulatory basis for the U.S. FDA’s expectations on the quality and analysis of excipients during drug development is primarily derived from 21 CFR 211.84(6)(d)(2). The overall control strategy and other information submitted by the drug developer is generally expected to address unreasonable and significant risk of illness or injury to human subjects as well as to provide sufficient information to allow regulators to assess potential risk to human subjects. This presentation will cover (1) the current scientific and regulatory rationale for using and controlling surfactants in protein formulations, (2) a pragmatic overview of the risk from surfactant degradation, (3) orthogonal strategies for controlling surfactant, host cell proteins, and related product quality attributes such as particulates in therapeutic proteins, (4) the types of studies that generally support the safe use of surfactants in protein formulations, and (5) the desired state of surfactant and related product quality attributes.
Date: Wednesday August 25, 2021 Mode: Online, ePosters Topic: «Precision Medicine» 1st Announcement (2021-05-09) Program (updated 2021-06-24) Poster Registration: open Fee: no charge for SAPhS members, CHF 150 for non-members
Awardee: Prof. Dr. Katalin Karikó, Senior Vice President, BioNTech RNA Pharmaceutical and Adjunct Associate Professor, Department of Neurosurgery, Perelman School of Medicine, University of Pennsylvania. Portrait of the Reichstein Prize winner. Ceremony: Monday September 6, 2021, 19:00 to 22 h; House University of Berne; participation only by invitation; for SAPhS members online transmission by Zoom (link available on request). Public lecture: Monday September 6, 2021, 14-15 h, University Hospital-Inselspital Bern, E. Rossi-Auditorium. Details follow.