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Near‐infrared spectroscopic evaluation of lyophilized viral vaccine formulations
Authors:Laurent Hansen  Thomas De Beer  Sigrid Pieters  Yvan Vander Heyden  Chris Vervaet  Jean Paul Remon  Jean‐Pierre Montenez  Rim Daoussi
Institution:1. Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Harelbekestraat 72, , 9000 Ghent, Belgium;2. Dept. of Analytical Chemistry and Pharmaceutical Technology, Center for Pharmaceutical Research, Vrij Universiteit Brussel, Laarbeeklaan 103, , 1090 Brussels, Belgium;3. Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, , 9000 Ghent, Belgium;4. Zoetis, Hoge Wei 10, , 1930 Zaventem, Belgium
Abstract: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). Herewith, two NIR spectral regions were evaluated: (i) the 7300–4000 cm?1 region containing the amide A/II band which might reflect information on the coated proteins of freeze‐dried live, attenuated viruses; and (ii) the C–H vibration overtone regions (10,000–7500 and 6340–5500 cm?1) which might supply information on the lipid layer surrounding the freeze‐dried live, attenuated viruses. The different pre‐freeze‐drying treated live, attenuated virus formulations (different virus states and virus volumes) resulted in different clusters in the scores plots resulting from the PCA of the collected NIR spectra. Secondly, partial least squares discriminant analysis models (PLS‐DA) were developed and evaluated, allowing classification of the freeze‐dried formulations according to virus pretreatment. The results of this study suggest the applicability of NIR spectroscopy for evaluating live, attenuated vaccine formulations with respect to their virus pretreatment and virus volume. © 2013 American Institute of Chemical Engineers Biotechnol. Prog., 29:1573–1586, 2013
Keywords:process analytical technology (PAT)  NIR spectroscopy  principal component analysis (PCA)  partial least square discriminant analysis (PLSDA)  freeze drying  live  attenuated vaccines
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