Analytical Technology for Biopharmaceutical Process and Product Characterization
NIST only participates in the February and August reviews.
Biopharmaceuticals are protein-based therapeutics produced through recombinant DNA technology in a variety of mammalian and non-mammalian hosts. Consistent control of the production process and resulting product are critical to ensuring their safety and efficacy. Analytical biochemistry plays a significant role in optimization of the production process, testing and clearance of associated impurities, and characterization of product- and process-related variants. The bioanalytical science group is directed toward developing a suite of fundamental measurement science, technology, standards, and reference data to enable more accurate and confident characterization of key attributes of protein drugs and their production process. We encourage research directed toward analytical mass spectrometry, separation science, and biochemistry of biopharmaceutical products for characterization (higher-order structure MS methods, top down sequencing, peptide mapping, glycoanalysis, PTM’s, size/charge heterogeneity), stability and associated phenomena (aggregation, accelerated stability, etc.), and associated production processes (bioreactor optimization and process impurities such as culture media and host cell proteins.)
Glycan; Glycoprotein; Chromatography; Biopharmaceutical; Mass spectrometry; Host cell protein;
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