SWISS PHARMA SCIENCE DAY (SPhSD) > repräsentativer Forschungsspiegel des Schweizer Pharmazie-Nachwuchses

Poster-Preisträger und ihre Abstracts:

1. Preis (Sponsor AKB-Stiftung): Evangelika Lekka, ETHZ (Gruppe Prof. Hall), lekka-31.pdf
2. Preis (Sponsor GSIA-Stiftung): Prof. Isidoro Caraballo, Universität Sevilla, caraballo-24.pdf
3. Preis (Sponsor PharmGZ): Dr. Linda Simmler, Universität Genf (Gruppe Prof. Lüscher), simmler-26.pdf
Bestes Poster Pharm. Biologie (Sponsor Zeller Söhne AG): Kevin Widmer, Universität Basel (Gruppe Prof. Ricklin), widmer-30.pdf
Bestes Poster Pharm. Technologie (Sponsor Glatt Group): Silvana Geisshüsler, ETHZ (Gruppe Prof. Gander), geisshuesler-38.pdf
Spezialpreis (Sponsor Vifor Pharma): Jonas Buck, Universität Basel (Gruppe Prof. Huwyler), buck-34.pdf
Proceedings und Tagungsbericht: sphsd_2019_conference_report.pdf


Poster-Preisträger und ihre Abstracts:

1. Preis: Simon Matoori, ETHZ, matoori-24.pdf
2. Preis: Anima Schäfer, Univ. Basel, schaefer-18.pdf
3. Preis: Marloes Zoetemelk, Univ. Genf, zoetemelk-22.pdf
Bestes Poster Pharm. Biologie: Stefanie Santos, Univ.spital Zürich & Univ. Basel, santos-12.pdf
Bestes Poster Pharm. Technologie:Annatina Romagna, Klus-Apotheke Zürich, romagna-21.pdf
Spezialpreis: Melanie Haag, Univ. Basel, haag-38.pdf
Proceedings und Tagungsbericht: sphsd_2018_conference_report.pdf

Poster-Preisträger und ihre Abstracts:
1. Preis: Emilie Aubry, Bern University Hospital-Inselspital & University of Bern
2. Preis: Vassily Vorobiev, University of Geneva
3. Preis: Alexandra Müller, University & University Hospital of Basel
Bestes Poster Pharm. Biologie: Aymeric Monteillier, University of Geneva
Bestes Poster Pharm. Technologie: Alexander Hämmerli, ZHAW
Spezialpreis: Andreas Schittny, University of Basel
Proceedings und Tagungsbericht: Conference Booklet incl. all Abstracts

2016, 2015, 2014: siehe "Veranstalungen / Bisherige"

Freitag 07. Mai 2021

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.