Screen, Select, Enhance: A joint evitria AG – Biofidus workflow for ADCC‑enhanced antibody development
We collaborated with evitria AG on an integrated workflow that connects evitria’s high‑throughput antibody expression and selection pipeline with mechanistic validation for ADCC‑enhanced candidates. The poster, authored by Julia Pizzolato (evitria AG) with contributions from our colleagues Julian Wichmann and Tobias Luttermann, reports that evitria’s in-licensed GlymaxX‑mediated afucosylated antibody technology selectively increase FcγRIIIa binding (including […]
FDA strengthens the role of analytical comparability in biosimilar development
Analytical Comparability at the Center of Modern Biosimilar Development The U.S. Food and Drug Administration (FDA) has recently updated its guidance with a set of new and revised draft Q&As on Biosimilar Development [1]. A key focus of this update is the clarification of conditions under which a non‑U.S. authorized reference product may be used […]
FDA – Waives Clinical Efficacy Studies
A New Era for Biosimilars: Powered by Analytics In a historic regulatory shift, the U.S. FDA has reportedly accepted the first application for a biosimilar monoclonal antibody without requiring a comparative clinical efficacy study. This landmark decision signals the beginning of a new era in biosimilar development, where scientific rigor and affordability converge. It also […]
A holistic analysis platform for assessing protein modification and functional activity
Linking Protein Modifications to Functional Impact. Protein modifications are critical for the efficacy, safety, and stability of therapeutic antibodies. Here, we introduce a comprehensive analysis platform tailored to assess post-translational modifications of therapeutic proteins hand in hand with their functional activity. In the present approach, we successfully applied peptide mapping with LC-ESI-MS to determine deamidation […]
Midas Pharma and Biofidus join forces for integrated Biotech Solutions
Biofidus AG is now a member of the Midas group. With the acquisition of Biofidus, a leading provider of structural and functional characterization of biopharmaceuticals, Midas Pharma has taken a major step forward in expanding its portfolio of biopharmaceutical services. With this merger, the companies expand their portfolios of service solutions, offering seamless and modular […]