Validation of a high-performance liquid chromatographic assay for the quantification of adenovirus type 5 particles.
作者： Julia Transfiguracion , Alice Bernier , Normand Arcand , Parminder Chahal , Amine Kamen
DOI: 10.1016/S0378-4347(01)00330-9
关键词:
摘要: Abstract An anion-exchange–high-performance liquid chromatography (AE–HPLC) method for the quantification of adenovirus type 5 (Ad5) total particles was validated according to performance criteria precision, specificity, linearity calibration and range, limit detection, quantification, accuracy recovery. The viral were detected by absorbance at 260 nm using photodiode array detector (PDA). Cesium chloride (CsCl) purified Ad5 lysate samples used validation method. Relative standard deviations (RSDs) inter-day, intra-day precision reproducibility both less than 10 2% peak area retention time, respectively. specific which eluted 8.0 min. presence DNA does not affect recovery accurate quantification. Based on error in prediction be 10%, working range established between 2×1010 7×1011 VP/ml with correlation coefficient 0.99975, deviation 6.14×109 a slope 3.04×105 VP/ml. varied 88 106% all investigated is statistically similar 100% 95% confidence interval.
elsevier.com
sci-hub.se 参考文章(8)
Paul W. Shabram, Daniel D. Giroux, Ann M. Goudreau, Richard J. Gregory, Mark T. Horn, Bernard G. Huyghe, Xioadong Liu, Mary H. Nunnally, Barry J. Sugarman, Suganto Sutjipto, Analytical Anion-Exchange HPLC of Recombinant type-5 Adenoviral Particles Human Gene Therapy. ,vol. 8, pp. 453- 465 ,(1997) , 10.1089/HUM.1997.8.4-453
I. Nadeau, A. Garnier, J. Côté, B. Massie, C. Chavarie, A. Kamen, Improvement of recombinant protein production with the human adenovirus/293S expression system using fed-batch strategies. Biotechnology and Bioengineering. ,vol. 51, pp. 613- 623 ,(2000) , 10.1002/(SICI)1097-0290(19960920)51:6<613::AID-BIT1>3.0.CO;2-K
Lloyd A Currie, None, Nomenclature in evaluation of analytical methods including detection and quantification capabilities (IUPAC Recommendations 1995) Pure and Applied Chemistry. ,vol. 67, pp. 1699- 1723 ,(1995) , 10.1351/PAC199567101699
F Blanche, B Cameron, A Barbot, L Ferrero, T Guillemin, S Guyot, S Somarriba, D Bisch, An improved anion-exchange HPLC method for the detection and purification of adenoviral particles Gene Therapy. ,vol. 7, pp. 1055- 1062 ,(2000) , 10.1038/SJ.GT.3301190
Jacob V. Maizel, David O. White, Matthew D. Scharff, The polypeptides of adenovirus: I. Evidence for multiple protein components in the virion and a comparison of types 2, 7A, and 12☆ Virology. ,vol. 36, pp. 115- 125 ,(1974) , 10.1016/0042-6822(68)90121-9
Vadim Klyushnichenko, Alice Bernier, Amine Kamen, Eef Harmsen, Improved high-performance liquid chromatographic method in the analysis of adenovirus particles. Journal of Chromatography B: Biomedical Sciences and Applications. ,vol. 755, pp. 27- 36 ,(2001) , 10.1016/S0378-4347(00)00597-1
Elisabeth Lehmberg, Joseph A Traina, John A Chakel, Ray-Jen Chang, Maria Parkman, Michael T McCaman, Peter K Murakami, Vafa Lahidji, Jeffrey W Nelson, William S Hancock, Eirik Nestaas, Erno Pungor Jr, None, Reversed-phase high-performance liquid chromatographic assay for the adenovirus type 5 proteome Journal of Chromatography B: Biomedical Sciences and Applications. ,vol. 732, pp. 411- 423 ,(1999) , 10.1016/S0378-4347(99)00316-3
N Mittereder, K L March, B C Trapnell, Evaluation of the concentration and bioactivity of adenovirus vectors for gene therapy. Journal of Virology. ,vol. 70, pp. 7498- 7509 ,(1996) , 10.1128/JVI.70.11.7498-7509.1996