Optimization of the Lowry method of protein precipitation from the H. influenzae type b conjugate vaccine using deoxycholic acid and hydrochloric acid

Biotechnology and Bioprocess Engineering

Volumn 11, Issue 3, 2006, Pages 215-222

  Kim, Hyun Sung ^a   Kim, Sang Joon ^a   Kim, Hui Jung ^a   Kim, Han Uk ^a   Ahn, Sang Joem ^a   Hur, Byung Ki ^b  

^a Berna Biotech Korea Corp   (South Korea)

^b Inha University   (South Korea)

Author keywords

Conjugate vaccine; Deoxycholic acid precipitation; Haemophilus influenzae type b; Lowry method; Method validation

Indexed keywords

BACTERIAL POLYSACCHARIDE; BACTERIAL PROTEIN; CARRIER PROTEIN; DEOXYCHOLIC ACID; HAEMOPHILUS INFLUENZAE TYPE B TETANUS VACCINE; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; HYDROCHLORIC ACID; SUCROSE; TETANUS TOXOID; UNCLASSIFIED DRUG;

ARTICLE; CONCENTRATION RESPONSE; CONTROLLED STUDY; DRUG ANTIGENICITY; DRUG DETERMINATION; FREEZE DRYING; HAEMOPHILUS INFLUENZAE TYPE B; INTERMETHOD COMPARISON; PH; PRECIPITATION; PROTEIN ANALYSIS; PROTEIN CONTENT; PROTEIN DETERMINATION; REPRODUCIBILITY; VALIDATION PROCESS;

HAEMOPHILUS INFLUENZAE SEROTYPE B;

EID: 33745634367     PISSN: 12268372     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF02932033     Document Type: Article

References (30)

1. Dajani, A. S., B. I. Asmar, and M. C. Thirumoorthi (1979) Systemic Haemophilus influenzae disease: an overview. J. Pediatr. 94: 355-364.
2. Granoff, D. M. and M. Basden (1980) Haemophilus influenzae infections in Fresno County, California: a prospective study of the effects of age, race, and contact with a case on incidence of disease. J. Infect. Dis. 141: 40-46.
3. Todd, J. K. and F. W. Bruhn (1975) Severe Haemophilus influenzae infections. Am. J. Dis. Child. 129: 607-611.
4. Cochi, S. L., C. V. Broome, and A. W. Hightower (1985) Immunization of US children with Haemophilus influenzae type b polysaccharide vaccine. A cost-effectiveness model of strategy assessment. J. Am. Med. Ass. 253: 521-529.
5. Coulehan, J. L., R. H. Michaels, K. E. Williams, D. K. Lemley, C. Q. North, Jr., T. K. Welty, and K. D. Rogers (1976) Bacterial meningitis in Navajo Indians. Public Health Rep. 91: 464-468.
6. Tarr, P. I. and G. Peter (1978) Demographic factors in the epidemiology of Haemophilus influenzae meningitis in young children. J. Pediatr. 92: 884-888.
7. Ward, J. (1991) Prevention of invasive Haemophilus influenzae type b disease: lessons from vaccine efficacy trials. Vaccine 9 Suppl: S17-S24.
8. Pittman, M. (1933) The action of type-specific Haemophilus influenzae antiserum. J. Exp. Med. 58: 683-706.
9. Onodera, M. (2002) Silicone rubber membrane bioreactors for bacterial cellulose production. Biotechnol. Bioprocess Eng. 7: 289-294.
10. Barrett, D. J. (1985) Human immune responses to polysaccharide antigens: an analysis of bacterial polysaccharide vaccines in infants. Adv. Pediatr. 32: 139-158.
11. Landsteinder, K. (1962) The Specificity of Serologic Reactions. Cambridge, Harvard University Press, Dover Publications, New York, NY, USA.
12. Bae C. S., S. S. Hong, S. J. Ahn, Y. S. Jang, and B. K. Hur (2005) Importance of the degree of antigen polymerization by detoxification in modulating the immunogenicity of acellular pertussis vaccine. Biotechnol. Bioprocess Eng. 10: 230-235.
13. Dick, W. E. and J. M. Beurret (1989) Glycoconjugates of bacterial carbohydrate antigens: A survey and consideration of design and preparation factors. pp. 48-113. In: J. M. Cruse and R. E. Lewis (eds.). Conjugate Vaccines Contrib. Microb. Immunol. Karger, Switzerland.
14. Lovrien, R. and D. Matulis (2003) Assays for total protein. pp. 18-24. In: J. E. Coligan, B. M. Duun, D. W. Speicher, and P. T. Wingfield (eds.). Short Protocols in Protein Science. John Wiley & Sons, Inc. Canada.
15. Korea Minimum Requirements of Biological Products (1999) Haemophilus influenzae Type b-Tetanus Toxoid Conjugate Vaccine. pp. 181-190. Korea Food & Drug Administration (KFDA), Seoul, Korea.
16. Smith, P. K., R. I. Krohn, G. T. Hermanson, A. K. Mallia, F. H. Gartner, M. D. Provenzano, E. K. Fujimoto, N. M. Goeke, B. J. Olson, and D. C. Klenk (1985) Measurement of protein using bicinchoninic acid. Anal. Biochem. 150: 76-85.
17. Lowry, O. H., N. J. Rosebrough, A. L. Farr, and R. J. Randall (1951) Protein measurement with the Folin phenol reagent. J. Biol. Chem. 193: 265-275.
18. Peterson, G. L. (1983) Determination of total protein. Meth. Enzymol. 91: 95-121.
19. Hartree, E. F. (1972) Determination of protein: A modification of the Lowry method that gives a linear photometric response. Anal. Biochem. 48: 422-427.
20. Peterson, G. L. (1979) Review of the Folin phenol protein quantitation method of Lowry, Rosebrough, Farr, and Randall. Anal. Biochem. 100: 201-220.
21. Guo, Y.-Y., R. Anderson, J. McIver, R. K. Gupta, and G. R. Siber (1998) A simple and rapid method for measuring unconjugated capsular polysaccharide (PRP) of Haemophilus influenzae type b in PRP-tetanus toxoid conjugate vaccine. Biologicals 26: 33-38.
22. Lei, Q. P., D. H. Lamb, R. Heller, and P. Pietrobon (2000) Quantitation of low level unconjugated polysaccharide tetanus toxoid-conjugate vaccine by HPAEC/PAD following rapid seperation by deoxycholate/HCl. J. Pharm. Biomed. Anal. 21: 1087-1091.
23. Tsai, C.-M., X.-X. Gu, and R. A. Byrd (1994) Quantification of polysaccharide in Haemophilus influenzae type b conjugate and polysaccharide vaccines by high-performance anion-exchange chromatography with pulsed amperometric detection. Vaccine 12: 700-706.
24. Guidance for Industry, Q2B Validation of Analytical Procedure: Methodology, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), November 1996, ICH.
25. Guidance for Industry, Biological Method Validation, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), May 2001, BP.
26. Annand, R. and P. L. Romeo (1976) Protein in food stuffs. Am. Lab. 8: 37-46.
27. Beyer, R. E. (1983) A rapid biuret assay for protein of whole fatty tissues. Anal. Biochem. 129: 483-485.
28. Markwell, M. A., S. M. Haas, N. E. Tolbert, and L. L. Bieber (1981) Protein determination in membrane and lipoprotein samples; manual and automated procedures. Meth. Enzymol. 72: 296-303.
29. Kim, H. S., T. H. Yoo, Y. S. Jang, H. Kim, J. Y. Park, B. K. Hur, Y. W. Ryu, and J. S. Kim (2004) An animal model to evaluate the protective efficacy of Haemophilus influenzae type b conjugate vaccines. Biotechnol. Bioprocess Eng. 9: 490-494.
30. Yoo, T. H., H. S. Kim, S. S. Park, E. Y. Bang, Y. K. Oh, L. S. Kim, H. Kim, B. K. Hur, Y. W. Ryu, and J. S. Kim (2003) Measurement of free polysaccharide in tetanus toxoid-conjugate vaccine using antibody/ ammonium sulfate precipitation. J. Microbiol. Biotechnol. 13: 469-472.