Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine

Vaccine

Volumn 26, Issue 36, 2008, Pages 4754-4757

  Ho, Mei M ^a   Markey, Kevin ^a   Rigsby, Peter ^a   Jensen, Sten E ^c   Gairola, Sunil ^c   Seki, Masaaki ^c   Castello Branco, Luiz R ^c   López Vidal, Yolanda ^c   Knezevic, Ivana ^b   Corbel, Michael J ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^b WORLD HEALTH ORGANIZATION   (Switzerland)

^c NONE

Author keywords

ATP; BCG; Viability

Indexed keywords

ADENOSINE TRIPHOSPHATE; BCG VACCINE;

ARTICLE; BACTERIAL VIABILITY; BCG VACCINATION; DENMARK; DRUG QUALITY; DRUG STABILITY; DRUG STORAGE; HEAT TREATMENT; PRIORITY JOURNAL; QUALITY CONTROL; REPRODUCIBILITY; WORLD HEALTH ORGANIZATION;

ADENOSINE TRIPHOSPHATE; BACTERIOLOGICAL TECHNIQUES; BCG VACCINE; COLONY COUNT, MICROBIAL; DRUG STORAGE; FREEZE DRYING; HUMANS; MICROBIAL VIABILITY; MYCOBACTERIUM BOVIS; REPRODUCIBILITY OF RESULTS; TEMPERATURE;

EID: 48649109921     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2008.06.026     Document Type: Article

References (6)

1. Requirements for dried BCG vaccine. WHO Expert committee on Biological Standardization. Annex 2. WHO Technical Report Series No. 745; 1987. p. 60-92.
2. BCG vaccine, Freeze-dried. European Pharmacopoeia. Directorate for the Quality of Medicines of the Council of Europe (EDQM). 6th ed. Strasbourg, Cedex, France; 2008 [01/2008: 0163].
3. Ho M.M., Corbel M.J., Knezevic I., and Roumiantzeff M. Report on a WHO consultation on the characterisation of BCG vaccines. WHO, Geneva, Switzerland, 8-9 Dec 2004. Vaccine 23 (2005) 5700-5704
4. Knezevic I., and Corbel M.J. WHO discussion on the improvement of the quality control of BCG vaccines. Pasteur Institute, Paris, France, 7 June 2005. Vaccine 24 (2006) 3874-3877
5. Jensen E, Hubrechts P, Klein B, Haslov KR. Development and validation of an ATP method for rapid estimation of viable units in lyophilized BCG Danish 1331 vaccine. Biologicals 2008; in press.
6. Lundin A. Use of firefly luciferase in ATP-related assays of biomass, enzymes, and metabolites. Methods Enzymol 305 (2000) 346-370