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.
Preisträgerin: Prof. Dr. Dr. h.c. Katalin Karikó, Senior Vice President, BioNTech RNA Pharmaceutical und Adjunct Associate Professor, Department of Neurosurgery, Perelman School of Medicine, University of Pennsylvania Porträt der Reichstein Preisträgerin 2021 Festakt: Montag 6. September 2021, 19:00 bis ca. 22 Uhr; Haus der Universität Bern Foto Gallery
Datum; Ort: Montag 6. September 2021, 14- 15 h; Auditorium Ettore Rossi, Kinderklinik, Universitätsspital-Inselspital Bern Referentin: Prof. Dr. Dr. h.c. Katalin Karikó, BioNTech RNA Pharm. & University of Pennsylvania; SAPhW Reichstein Medaillen-Preisträgerin 2021. Thema: «Developing mRNA for Therapy» Porträt der Referentin Poster Foto Gallery Medienberichte: 20Min-1, 20Min-2
Conference booklet: download pdf Conference report: download pdf Videostream: watch whole event Lecture 1, Prof. Serena Nik-Zainal: watch presentation Lecture 2, Prof. Olav Lapaire: watch presentation Lecture 3, Prof. Hans Leuenberger: watch presentation Lecture 4, Prof. Mark Rubin: watch presentation Platform 1, Kathrin Ahrens, GSIA: watch presentation Platform 2, Sara Iten, GSASA: watch presentation Platform 3, Dr. Andreas Schittny, swissYPG: watch presentation e-Posters: watch gallery Fellows and poster prizes: watch award gallery Evaluation: watch MonkeySurvey results
University Hospital - Inselspital Bern and House of University of Bern, 6 Sept. 2021 Awardee: Prof. Dr. Dr. h.c. Katalin Karikó, Senior Vice President, BioNTech RNA Pharmaceutical and Adjunct Associate Professor, Department of Neurosurgery, Perelman School of Medicine, University of Pennsylvania Portrait of Prof. Katalin Karikó: download pdf Award lecture: - Videostream: watch whole lecture - Lecture Prof. Karikó: download pdf of presentation - Fotos: download gallery Award ceremony: - Videostream: watch whole ceremony - Welcome and Laudatio: download pdf of presentation - Welcome address Prof. H. Leuenberger: watch video - Fotos: download gallery Media reports: 20Min-1, 20Min-2, SAeZ, CH Media