Formulation and Quality – Biomolecular
As the number of particle measurement methods have expanded beyond the pharmacopeial methods of light obscuration, membrane microscopy, and visual inspection, questions have arisen about how we can establish confidence in these new methods. Our fundamental understanding of how these instruments respond to different particle types has increased, and we can begin to use reference materials or other standards to better qualify instruments or validate methods. In this session, I will discuss the application of standards ranging from mixtures of microspheres in the submicrometer range to lithographic particles that have the appearance of large aggregated proteins. Examples will include the application of a NIST reference material for particle size and morphology. Open questions are how best to implement quality control methods that are reliable, efficient, and user-friendly.