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Analytical outlook for biosimilar development

Date

Thursday, April 29, 2021

Time

03:00 PM Europe/Warsaw

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Agenda

The variability and complexity of biological medicines compel extensive and comprehensive characterization studies to ensure safety and efficacy. Compared to small-molecule drugs, structural and functional characterization of biologics can be a tedious and challenging process. It involves using state-of-the-art technologies to evaluate the purity, specificity, potency, and toxicity, all in accordance with international regulatory guidelines. During the webinar, Selvita’s Experts intend to characterize regulatory requirements and provide an outlook for analytical approaches for biosimilar development and manufacturing process changes.

The webinar will feature a discussion between some of Selvita’s most experienced scientific team members: Magdalena Bielak-Łakomska, Associate Director in Analytics, and Jan Smagur, Director of Cell and Molecular Biology Laboratory, moderated by Krzysztof Stawujak, Business Development Manager.

AGENDA

  1. 15:00 to 15:05: Introduction – Krzysztof Stawujak
  2. 15:05 to 15:35: Presentation: Analytical outlook for biosimilar development – Magdalena Bielak-Łakomska, Jan Smagur
  3. 15:35 to 16:00: Q&A session
Presenter

Krzysztof Stawujak

Business Development Manager, Selvita S.A.
Presenter

Magdalena Bielak-Łakomska

Associate Director in Analytics, Selvita S.A.
Presenter

Jan Smagur

Director of Cell and Molecular Biology Laboratory, Selvita S.A.