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Publication Citation: The Metrology of Counting Protein Particles

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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
Pages: 6 pp.
Location: Anaheim, CA
Dates: March 18-22, 2013
Keywords: aggregate; light obscuration; microscopy; particle; pharmaceutical; protein; reference material
Research Areas: Biological Product Characterization, Drugs/Pharmaceuticals
PDF version: PDF Document Click here to retrieve PDF version of paper (2MB)