Development and validation of an ATP method for rapid estimation of viable units in lyophilised BCG Danish 1331 vaccine

Jensen, Sten E.; Hubrechts, Peter; Klein, Bjarke M.; Hasløv, K

doi:10.1016/j.biologicals.2008.05.001

Cited by 24 publications

(21 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Traditionally plating is the method of choice, but bioluminescence analysis, espe cially suitable for viability testing of slowly growing organ isms, can serve this function. A number of publications describe application of bioluminescence analysis for assess ment the viability of lyophilized BCG vaccines [73,74].…”

Section: Determination Of Intracellular Atp In a Mixed Culture Of Micmentioning

confidence: 99%

“…The most significant work on the use of the biolumi nescence ATP assay for viability testing of the BCG vac cine is a study of Danish scientists [80], where not only the method for quantitative determination of the viability of the BCG vaccine based on the amount of intracellular ATP was described, but the method was thoroughly vali dated. They used industrial samples of lyophilized BCG vaccine (strain 1331 from the Danish collection).…”

Section: Determination Of Intracellular Atp In a Mixed Culture Of Micmentioning

confidence: 99%

“…According to [80], additional incubation in nutrient medium for one day was required to restore cell viability completely and to obtain good correlation between ATP content and CFU number. However, it was shown in [82] that a 30 min incubation of the lyophilized vaccine rehy drated in Sauton solution was sufficient for restoration of viability of the lyophilized mycobacteria, and satisfactory correlation between the ATP concentration and the CFU numbers was observed.…”

Section: Determination Of Intracellular Atp In a Mixed Culture Of Micmentioning

confidence: 99%

“…It must be emphasized that apyrase does not penetrate inside the cells, like other proteins, and therefore it does not affect the intracellular ATP content. According to the litera ture, 10 min incubation of the cell suspension in dilute apyrase solution decreases the concentration of the extra cellular ATP by hundred folds [80]. In study [82], the apyrase was added into the Sauton solution.…”

Section: Determination Of Intracellular Atp In a Mixed Culture Of Micmentioning

confidence: 99%

“…BIOCHEMISTRY (Moscow) Vol. 80 No. 6 2015 Luminometers -specialized instruments that were first introduced to the market in 1970s -are used for bioluminescence measurements.…”

mentioning

confidence: 96%

See 4 more Smart Citations

Bioluminescence assay for cell viability

Lomakina

Modestova

Ugarova

2015

Biochemistry Moscow

View full text Add to dashboard Cite

Theoretical aspects of the adenosine triphosphate bioluminescence assay based on the use of the firefly luciferin-luciferase system are considered, as well as its application for assessing cell viability in microbiology, sanitation, medicine, and ecology. Various approaches for the analysis of individual or mixed cultures of microorganisms are presented, and capabilities of the method for investigation of biological processes in live cells including necrosis, apoptosis, as well as for investigation of the dynamics of metabolism are described.

show abstract

Section: Determination Of Intracellular Atp In a Mixed Culture Of Micmentioning

confidence: 99%

Section: Determination Of Intracellular Atp In a Mixed Culture Of Micmentioning

confidence: 99%

Section: Determination Of Intracellular Atp In a Mixed Culture Of Micmentioning

confidence: 99%

Section: Determination Of Intracellular Atp In a Mixed Culture Of Micmentioning

confidence: 99%

“…BIOCHEMISTRY (Moscow) Vol. 80 No. 6 2015 Luminometers -specialized instruments that were first introduced to the market in 1970s -are used for bioluminescence measurements.…”

mentioning

confidence: 96%

See 3 more Smart Citations

Bioluminescence assay for cell viability

Lomakina

Modestova

Ugarova

2015

Biochemistry Moscow

View full text Add to dashboard Cite

show abstract

The Role of Fermentation in BCG Manufacture: Challenges and Ways Forward

Walker¹,

Bacon²

2023

Vaccines for Neglected Pathogens: Strategies, Achievements and Challenges

View full text Add to dashboard Cite

The BCG vaccine has been in existence for a century and has been instrumental in the control of tuberculosis. The method for producing the vaccine has not changed in a very long time and consists of pellicle growth followed by ball-milling, which is a lengthy and variable approach. There has been increasing interest in the possibility of producing the BCG vaccine by growing it in bioreactors, which could address some of the issues around variation between batches, increase yield, and circumvent the challenges associated with supply and demand. There is evidence that fermentation would be a quicker, more reproducible method of production, and would deliver BCG to a higher yield in a form that would be easier to characterise. However, a change to the manufacturing process may require new evidence of bioequivalence and may attract a requirement for preclinical studies as well as clinical trials from Phase I, through to efficacy studies. This chapter describes the history of the BCG vaccine and the issues of the current production method. We discuss the potential benefits of BCG fermentation and the regulatory steps required for such a method of production to be implemented.

show abstract