A practical approach to optimization and validation of a HPLC assay for analysis of polyribosyl-ribitol phosphate in complex combination vaccines

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 832, Issue 2, 2006, Pages 208-215

  Belfast, Mary ^a   Lu, Rong ^a   Capen, Robert ^a   Zhong, Jinglin ^a   Nguyen, Mai Anh ^a   Gimenez, Juan ^a   Sitrin, Robert ^a   Mancinelli, Ralph ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Assay optimization; Assay validation; Combination vaccine; Design of experiment; HPLC; PRP

Indexed keywords

DISSOLUTION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; OPTIMIZATION; PHOSPHATES; STATISTICAL METHODS;

ASSAY OPTIMIZATION; ASSAY VALIDATION; COMBINATION VACCINE; DESIGN OF EXPERIMENT; PRP;

BIOASSAY;

BACTERIAL VACCINE; DIPHTHERIA PERTUSSIS TETANUS VACCINE; HEPATITIS B VACCINE; POLIOMYELITIS VACCINE; POLYRIBOSYL RIBITOL PHOSPHATE VACCINE; UNCLASSIFIED DRUG;

ARTICLE; DEPOLYMERIZATION; DRUG CONJUGATION; DRUG DETERMINATION; DRUG ISOLATION; DRUG SOLUBILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; METHODOLOGY; PRIORITY JOURNAL; VACCINE PRODUCTION;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; POLYSACCHARIDES; ULTRACENTRIFUGATION; VACCINES, COMBINED;

BACTERIA (MICROORGANISMS);

EID: 33644772124     PISSN: 15700232     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchromb.2005.12.053     Document Type: Article

References (19)

1. P.J. Kniskern, S. Marburg, and R. Ellis Vaccine Design: The Subunit and Adjuvant Approach, Chapter 30: Haemophilus influenzae Type b Conjugate Vaccines 1995 Plenum Press New York p. 673
2. J.E. Plumb, and S.E. Yost Vaccine 14 1996 399
3. W. Egan, R. Schneerson, K.E. Werner, and G. Zon J. Am. Chem. Soc. 104 1982 2898
4. A.W. Sturgess, K. Rush, R. Charbonneau, J.I. Lee, D.J. West, R.D. Sitrin, and J.P. Hennessey Jr. Vaccine 17 1999 1169
5. C. Chu, R. Schneerson, J.B. Robbins, and S. Rastogi Infect. Immunity 40 1983 245
6. J. Eskola, J. Ward, R. Dagan, D. Goldblatt, F. Zepp, and C.A. Siegrist Lancet 1354 1999 2063
7. S.L. Kaplan Pediatric Annals 19 1990 712
8. C.M. Tsai, X. Gu, and R.A. Byrd Vaccine 12 1994 700
9. G.E.P. Box, W.G. Hunter, J.S. Hunter, Statistics for Experimenters, an Introduction to Design, Data Analysis and Model Building, New York, NY, 1978.
10. G.E.P. Box, and K.B. Wilson J. Royal Stat. Soc. 13B 1951 1
11. Design-Expert® by Stat-Ease Inc., version 6.0.1, copyright 1999, 2021 East Hennepin Avenue, Suite 191, Minneapolis, MN, 55413.
12. J. Klein, R. Capen, R. Mancinelli, R. Robinett, P.J.F. Pietrobon, J. Quinn, and T. Schofield Biologics 27 1999 35
13. N.R. Draper, and H. Smith Applied Regression Analysis 1981 John Wiley & Sons, Inc. New York, NY
14. P. Hubert, P. Chiap, J. Crommen, B. Boulanger, E. Chapuzet, N. Mercier, S. Bervoas-Martin, P. Chevalier, D. Grandjean, P. Lagorce, M. Lallier, M. Laparra, M. Laurentie, and J. Nivet Chim. Acta 391 1999 135
15. L.R. Synyder, and J.J. Kirkland Introduction to Modern Liquid Chromatography second ed. 1979 John Wiley and Sons New York
16. H. Small Modern Analytical Chemistry, Ion Chromatography 1989 Plenum Press New York
17. JMP Statistical Discovery Software® version 3.2 Profession Edition, copyright 1989-1997, SAS Institute Inc., SAS Campus Drive, Cary, NC.
18. ICH Harmonized Tripartite Guideline, "Validation of Analytical Procedures", Recommended for Adoption at Step 4 of the ICH Process on 27 October 1994 by the ICH Steering Committee, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
19. ICH Harmonized Tripartite Guideline, "Q2B Validation of Analytical Procedures: Methodology", Recommended for Adoption at Step 4 of the ICH Process on 6 November 1996 by the ICH Steering Committee, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.