NIST only participates in the February and August reviews.
This research involves the development of measurement methods, sensors, or standards for characterizing key attributes of manufactured biological products, primarily therapeutic proteins that impact their efficacy and safety. Of particular interest is the measurement of protein aggregates and protein particulates. These efforts range from studying fundamental aspects of protein aggregation to the development of potential reference materials for improved measurements of protein aggregates and particulates. Methods used in our studies include microflow imaging, light obscuration, coulter counting, size exclusion chromatography, light scattering, atomic force microscopy, and electrospray ionization-differential mobility analysis.
Biomanufacture; Bioprocessing; Glycoprotein; Process analytical technology; Protein aggregation; Vaccine; Virus;
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