Standardization and validation of Vero cell assay for potency estimation of diphtheria antitoxin serum

Biologicals

Volumn 37, Issue 5, 2009, Pages 297-305

  Kumar, Sunil ^a   Kanwar, Sarika ^a   Bansal, Vivek ^a   Sehgal, Rakesh ^b  

^a CENTRAL DRUG RESEARCH INSTITUTE   (India)

^b POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH   (India)

Author keywords

Antitoxin; Diphtheria; Vero cell assay

Indexed keywords

DIPHTHERIA ANTIBODY;

ACCURACY; ANIMAL CELL; ANIMAL EXPERIMENT; ANTIBODY TITER; ARTICLE; CONTROLLED STUDY; DRUG POTENCY; FEMALE; FLOCCULATION; HUMAN; HUMAN CELL; IMMUNIZATION; MALE; NONHUMAN; PRIORITY JOURNAL; QUALITY CONTROL; SENSITIVITY AND SPECIFICITY; STANDARDIZATION; VACCINE PRODUCTION; VALIDATION PROCESS; VERO CELL;

ANIMALS; ANTIBODY SPECIFICITY; CERCOPITHECUS AETHIOPS; DIPHTHERIA ANTITOXIN; FEMALE; GUINEA PIGS; HORSES; IMMUNE SERA; MALE; MODELS, BIOLOGICAL; NEUTRALIZATION TESTS; REFERENCE STANDARDS; SENSITIVITY AND SPECIFICITY; TEMPERATURE; TIME FACTORS; VERO CELLS;

MAMMALIA;

EID: 69649100730     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2009.05.002     Document Type: Article

References (14)

1. Indian Pharmacopoeia, vol. 1; 1996. p. 261.
2. Brown F., Cussler K., and Hendriksen C. Replacement, reduction and refinement of animal experiments in the development of biological products. Dev Biol Stand 86 (1996) 207
3. Russel W.M.S. Vaccines, animals and man. Dev Biol Stand 101 (1997) 3-12 Cited from: Brown F, Hendrikson C, Sesardic D. 1999
4. Kreftenberg J.G., Gun J.C.D., Marsman F.R., Sekhuis V.M., Bhandari S.K., Maheshwari S.C., et al. An investigation of mouse model to estimate the potency of the diphtheria component in vaccines. J Biol Stand 13 (1985) 229
5. Levaditi C., and Mutermilch S.T. Action de La tixine diphtherique Sur la survie des cellules in-vitro. C R Soc Biol (Paris) 74 (1913) 379 Cited from: Pappenheimer Jr AM. Diphtheria. In: Germanier R, editor. Bacterial vaccines; 1984
6. Okabe L. Kitasato Arch Exp Med 10 (1933) 41 Cited from: Sousa CP, Evans DG. The action of diphtheria toxin on tissue cultures and its neutralization by antitoxin. Br J Exp Path 1957; 38: 644
7. Kriz B., Burian V., Sladky K., Burianova B., Mottlova O., and Roth Z. Comparison of titration results of diphtheric antitoxic antibodies obtained by means of Jensen's method and the methods of tissue culture and haemagglutination. J Hyg Epidemiol Microbiol Immunol 22 (1978) 485-493
8. World Health Organization. Validation of analytical procedures used in the examination of pharmaceutical materials. WHO expert committee on specification for pharmaceutical preparations. Technical Report Series vol. 823 (1992), WHO 117-121
9. Darling A.J., Boose J.A., and Spaliro J. Virus assay methods: accuracy and validation. Biologicals 26 (1998) 105-110
10. British Pharmacopoeia. Assay validation vol. IV (2003) p. A-457
11. International Conference on Harmonization (ICH) of technical requirements for the registration of pharmaceuticals for human use. Validation of analytical procedures: definition and terminology. ICH-Q2B, Geneva. In: Robert A.N., and Alfred H.W. (Eds). Pharmaceutical process validation, 2003 vol. 129 (1995) p. 507-14
12. International Conference on Harmonization (ICH) of technical requirements for the registration of pharmaceuticals for human use. Validation of analytical procedures: methodology. ICH-Q2B, Geneva. In: Robert A.N., and Alfred H.W. (Eds). Pharmaceutical process validation, 1995 vol. 129 (1996) p. 515-24
13. Ramon G. A proper du titerage in-vitro du serum Antidiphtherique. C R Soc Biol 86 (1922) 813 Cited from: Pappenheimer Jr AM. Diphtheria. In: Germanier R, editor. Bacterial vaccines; 1984. p. 1-36
14. WHO. Vero cell method for testing the potency of diphtheria toxoids. Pact 3. Manual of laboratory methods (1997), WHO, Geneva WHO/VSQ/97.04