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Get a walk-through on how phase-appropriate bioassays and functional assessments deliver decision-ready, regulatory-aligned data that pave the way for successful clinical and commercial outcomes for biologics and bioconjugates.
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Access this recent scientific poster to uncover how rapid, multidimensional assessments that optimize stability, manufacturability, and safety can accelerate lead candidate selection, advancing only the most promising therapeutics toward clinical trials.
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Hear from bioassay expert, Dr. Erika Kovacs, as she discusses critical considerations for developing stage-appropriate bioassays to support complex biologics and bioconjugates on the path to IND. Using real-world case studies, she shares insights on selecting the right assay based on the molecule’s MoA and stage of development.
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By improving the granularity and interpretability of preclinical immunogenicity data, the next-gen EpiScreen® 2.0 in vitro assay platform was designed to provide a more comprehensive and predictive assessment of immunogenicity risk during early-stage biologic development. This sensitive and data-rich tool supports more confident lead selection and helps mitigate downstream clinical risks.
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Demonstrating the absence of unwanted effector functions is crucial for safety purposes, particularly in cancer therapeutics. In this session, our experts examine key considerations for developing effective Fc-mediated functional assays, highlighting the advantages and limitations of various assay formats. Their case studies will showcase how rigorous data trending leads to reliable assays and how more complex formats contribute to understanding the MoA and selecting the most promising lead.
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In this co-authored journal publication with the FDA, explore how MHC Associated Peptide Proteomics (MAPPS) demonstrates promise as a valuable tool for comprehensive immunogenicity assessment in therapeutic protein development, contributing to safer and more effective biologics.
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