Referent: Ashutosh Rao, Ph.D., Center for Drug Evaluation and Research, U.S. Food and Drug Administration Thema: «Scientific and regulatory perspectives on control strategies for excipients in biotechnology drugs» Datum, Zeit: Freitag 7. Mai 2021, 14:00 – 15 h Modus: 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.