Scientific Publications by FDA Staff

J Pharm Sci 2012 Oct;101(10):3555-9

Workshop on predictive science of the immunogenicity aspects of particles in biopharmaceutical products.

Marszal E, Fowler E

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.