A common degradation pathway for protein-based drugs is the growth of protein aggregates or particles. Counting and characterization of these particles is needed to assure the quality, efficacy, and safety of this type of drug. The unusual physical attributes of protein particles lead to difficulties in obtaining accurate particle counts with traditional calibration standards and methods. We describe the development of instrument-response models, novel instrumentation, and novel reference materials to address this metrology issue.
Proceedings Title: Proceedings of the Measurement Science Conference
Conference Dates: March 18-22, 2013
Conference Location: Anaheim, CA
Pub Type: Conferences
aggregate, light obscuration, microscopy, particle, pharmaceutical, protein, reference material