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Regulatory Services

    Analytical outlook for biosimilar development

    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.