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|Author(s):||Dean C. Ripple; Michael J. Carrier; Richard E. Cavicchi; Christopher B. Montgomery; Zhishang Hu;|
|Title:||The Metrology of Counting Protein Particles|
|Published:||March 18, 2013|
|Abstract:||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:||Proceedings of the Measurement Science Conference|
|Dates:||March 18-22, 2013|
|Keywords:||aggregate, light obscuration, microscopy, particle, pharmaceutical, protein, reference material|
|Research Areas:||Biological Product Characterization, Drugs/Pharmaceuticals|
|PDF version:||Click here to retrieve PDF version of paper (2MB)|