NIR transmission spectroscopy for rapid determination of lipid and lyoprotector content in liposomal vaccine adjuvant system CAF01
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NIR transmission spectroscopy for rapid determination of lipid and lyoprotector content in liposomal vaccine adjuvant system CAF01. / Christensen, Dennis; Allesø, Morten; Rosenkrands, Ida; Rantanen, Jukka Tapio; Foged, Camilla; Agger, Else Marie; Andersen, Peter; Nielsen, Hanne Mørck.
In: European Journal of Pharmaceutics and Biopharmaceutics, Vol. 70, No. 3, 2008, p. 914-920.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - NIR transmission spectroscopy for rapid determination of lipid and lyoprotector content in liposomal vaccine adjuvant system CAF01
AU - Christensen, Dennis
AU - Allesø, Morten
AU - Rosenkrands, Ida
AU - Rantanen, Jukka Tapio
AU - Foged, Camilla
AU - Agger, Else Marie
AU - Andersen, Peter
AU - Nielsen, Hanne Mørck
PY - 2008
Y1 - 2008
N2 - It is of crucial importance to determine the concentration of the different components in the formulation accurately, during production. In this respect, near-infrared (NIR) spectroscopy represents an intriguing alternative that offers rapid, non-invasive and non-destructive sample analysis. This method, combined with multivariate data analysis was successfully applied to quantify the total concentration of lipids in the liposomal CAF01 adjuvant, composed of the cationic surfactant dimethyldioctadecylammonium bromide (DDA) and the immunomodulator α,α′-trehalose 6,6′-dibehenate (TDB). The near-infrared (NIR) detection method was compared to a validated high-performance liquid chromatography (HPLC) method and a differential scanning calorimetry (DSC) analysis, and a blinded study with three different sample concentrations was performed, showing that there was no significant difference in the accuracy of the three methods. However, the NIR and DSC methods were more precise than the HPLC method. Also, with the NIR method it was possible to differentiate between various concentrations of trehalose added as cryo-/lyoprotector. These studies therefore suggest that NIR can be used for real-time process control analysis in the production of CAF01 liposomes.
AB - It is of crucial importance to determine the concentration of the different components in the formulation accurately, during production. In this respect, near-infrared (NIR) spectroscopy represents an intriguing alternative that offers rapid, non-invasive and non-destructive sample analysis. This method, combined with multivariate data analysis was successfully applied to quantify the total concentration of lipids in the liposomal CAF01 adjuvant, composed of the cationic surfactant dimethyldioctadecylammonium bromide (DDA) and the immunomodulator α,α′-trehalose 6,6′-dibehenate (TDB). The near-infrared (NIR) detection method was compared to a validated high-performance liquid chromatography (HPLC) method and a differential scanning calorimetry (DSC) analysis, and a blinded study with three different sample concentrations was performed, showing that there was no significant difference in the accuracy of the three methods. However, the NIR and DSC methods were more precise than the HPLC method. Also, with the NIR method it was possible to differentiate between various concentrations of trehalose added as cryo-/lyoprotector. These studies therefore suggest that NIR can be used for real-time process control analysis in the production of CAF01 liposomes.
U2 - 10.1016/j.ejpb.2008.07.007
DO - 10.1016/j.ejpb.2008.07.007
M3 - Journal article
C2 - 18694823
VL - 70
SP - 914
EP - 920
JO - European Journal of Pharmaceutics and Biopharmaceutics
JF - European Journal of Pharmaceutics and Biopharmaceutics
SN - 0939-6411
IS - 3
ER -
ID: 9830335