Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.

aDepartment of Pharmaceutical Sciences, Center for Pharmaceutical Biotechnology, University of Colorado Health Sciences Center, Denver, CO 80262 bDepartment of Chemical and Biological Engineering, Center for Pharmaceutical Biotechnology, University of Colorado, Boulder, CO 80309 cDivision of Drug Delivery Technology, Leiden/Amsterdam Center for Drug Research (LACDR), Leiden University, Leiden, The Netherlands dDepartment of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands eDepartment of Pharmaceutical Chemistry, The University of Kansas, Lawrence, Kansas 66047 fDepartment of Pharmacy, Ludwig Maximilians University, 81377 Munich, Germany gDivision of Therapeutic Proteins, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD 20857 hOffice of Biotechnology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD 20857 iDivision of Monoclonal Antibodies, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD 20857