John Wiley & Sons Inc. / IgG / Davis KG / HP / USA INTRODUCTION CO / /
Facility
University of Colorado Denver / /
IndustryTerm
pharmaceutical formulation / complicated manufacturing processes / protein product / drug product / post-manufacturing change product / column media / microflow imaging / chemical degradation / stainless steel particles / therapeutic protein product / pre-change product / manufacturing / chemical means / steel particles / vaccine delivery systems / degradation products / aqueous solution / manufacturing processes / stainless steel nanoparticles / therapeutic protein products / /
MedicalCondition
cellular deficiency / frank anaphylactic reactions / /
Organization
University of Colorado Denver / U.S. Food and Drug Administration / RI AL / Division of Therapeutic Proteins / TE JOHN F. CARPENTER MA Department of Pharmaceutical Sciences / U.S. Securities and Exchange Commission / /
Person
AMY S. ROSENBERG / BARRY CHERNEY / Christian Mahler / /
The Critical Need for Robust Assays for Quantitation and Characterization of Aggregates of Therapeutic Proteins