Spectroscopic evaluation of a freeze-dried vaccine during an accelerated stability study.

This research evaluates a freeze-dried live, attenuated virus vaccine during an accelerated stability study using Near Infrared (NIR) and Fourier Transform Infrared (FTIR) spectroscopy in addition to the traditional quality tests (i.e., potency assay and residual moisture analysis) and Modulated Differential Scanning Calorimetry (MDSC).

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

This article examines the applicability of Fourier Transform Infrared (FTIR) spectroscopy to detect the applied virus medium volume (i.e., during sample filling), to evaluate the virus state and to distinguish between different vaccine doses in a freeze dried live, attenuated vaccine formulation.

Near-infrared spectroscopic evaluation of lyophilized viral vaccine formulations.

This article examines the applicability of near-infrared spectroscopy (NIRS) to evaluate the virus state in a freeze-dried live, attenuated vaccine formulation. Therefore, this formulation was freeze-dried using different virus volumes and after applying different pre-freeze-drying virus treatments (resulting in different virus states): (i) as used in the commercial formulation; (ii) without antigen (placebo); (iii) concentrated via a centrifugal filter device; and (iv) stressed by 96 h exposure to room temperature. Each freeze-dried product was measured directly after freeze-drying with NIR spectroscopy and the spectra were analyzed using principal component analysis (PCA).