title: Deep-ultraviolet (UV) resonance raman spectroscopy as a tool for quality control of formulated therapeutic proteins.
abstract: A deep-ultraviolet (UV) Raman spectrometer with excitation source tunable from 193 to 210 nm has been built and characterized. The dispersion of the spectrometer over the entire range was measured and described theoretically. The relative sensitivity of the spectrometer was estimated using the integrated intensity ratio of two Raman bands of cyclohexane. Resonance Raman spectra of three formulated insulin products were measured and compared. A band-targeted entropy minimization algorithm was applied to the collected spectra for mixture analysis of insulin products. We conclude that it is feasible to develop robust qualitative methods for quality control of protein-based formulated drug using DUVRR spectroscopy.
authors.affiliation: Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, Saint Louis, MO 63101, USA. sergey.arzhantsev@fda.hhs.gov
authors.forename: Sergey
authors.initials: S
authors.lastname: Arzhantsev
authors.forename: Vincent
authors.initials: V
authors.lastname: Vilker
authors.forename: John
authors.initials: J
authors.lastname: Kauffman
mesh_terms: D000465:Algorithms; D006801:Humans; D061386:Insulin, Regular, Human / Q000737:chemistry / Q000592:standards; D008956:Models, Chemical; D004364:Pharmaceutical Preparations / Q000737:chemistry* / Q000592:standards; D011786:Quality Control; D011994:Recombinant Proteins / Q000737:chemistry* / Q000592:standards; D013056:Spectrophotometry, Ultraviolet / Q000379:methods*; D013059:Spectrum Analysis, Raman / Q000379:methods*
chemical_list: D061386:Insulin, Regular, Human; D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins