FTIR spectroscopy for the detection and evaluation of live attenuated viruses in freeze dried vaccine formulations

摘要: This article examines the applicability of Fourier Transform Infrared (FTIR) spectroscopy to detect applied virus medium volume (i.e., during sample filling), evaluate state and distinguish between different vaccine doses in a freeze dried live, attenuated formulation. Therefore, formulations were after preparing them with volumes 30, 100, 400 µl) or applying pre-freeze-drying treatments (resulting states); i.e., (i) as done for commercial formulation; (ii) samples without (placebo); (iii) but free from antigen; (iv) concentrated obtained via centrifugal filter device; (v) stressed by 96h exposure room temperature; using (placebo, 25-dose vials, 50-dose-vials 125-dose vials). Each freeze-dried product was measured directly freeze-drying FTIR spectroscopy. The collected spectra analyzed principal component analysis (PCA) evaluated at three spectral regions, which might provide information on coated proteins viruses: 1700–1600 cm−1 (amide I band), 1600–1500 II band) 1200–1350 III band). latter band does not overlap water signals is hence influenced residual moisture samples. It proven that could prepared volumes, containing amide region. © 2015 American Institute Chemical Engineers Biotechnol. Prog., 31:1107–1118,