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Updated: May 21, 2026

Predictive Immune Modeling of Solid Tumors
Published on: February 25, 2020
Workshop on predictive science of the immunogenicity aspects of particles in biopharmaceutical products
Ewa Marszal1, Elizabeth Fowler
1Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA. ewa.marszal@fda.hhs.gov
Abstract:
Particles in protein therapeutics and concerns for a potential correlation with product immunogenicity are increasingly becoming the focus of recent publications and scientific forums. The consensus of academic, industrial, and regulatory scientists is that this area is not well understood and will require in-depth research because of the potential impact on the product safety and efficacy. This commentary presents a summary of the 1-day workshop entitled "Predictive Science of the Immunogenicity Aspects of Particles in Biopharmaceutical Products," which discussed the current state of analytical resources for quantitation and characterization of protein aggregates and potential paths for developing predictive preclinical tools.
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