A case study of development, validation, and acceptance of a non-animal method for assessing human vaccine potency

Descamps, J.; Giffroy, D; Rémy, É.; Mortiaux, Frédéric; Mareschal, Jean‐Claude; Ponsar, Cecile; Duchêne, Michel

doi:10.1016/j.provac.2011.10.018

Cited by 20 publications

(7 citation statements)

References 2 publications

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“…Potency is then measured on the final formulated drug product as a separate measurement from the protein dose. Originally, this potency was determined by an in vivo assay in mice and expressed as an ED 50 or relative ED 50 value compared to a standard (Descamps et al 2011;EP 2010b). An in vitro potency assay based on the Abbott Auszyme Sandwich ELISA kit was later developed to replace the in vivo assay (Descamps et al 2011).…”

Section: Release Strategy and Potencymentioning

confidence: 99%

“…Originally, this potency was determined by an in vivo assay in mice and expressed as an ED 50 or relative ED 50 value compared to a standard (Descamps et al 2011;EP 2010b). An in vitro potency assay based on the Abbott Auszyme Sandwich ELISA kit was later developed to replace the in vivo assay (Descamps et al 2011). When this kit was discontinued, an in house competitive inhibition ELISA needed to be developed (Descamps et al 2011).…”

Section: Release Strategy and Potencymentioning

confidence: 99%

“…An in vitro potency assay based on the Abbott Auszyme Sandwich ELISA kit was later developed to replace the in vivo assay (Descamps et al 2011). When this kit was discontinued, an in house competitive inhibition ELISA needed to be developed (Descamps et al 2011). At Merck, an in vitro sandwich ELISA potency test was also developed and validated based on the Abbott Auszyme Sandwich ELISA kit (Schofield 2002).…”

Section: Release Strategy and Potencymentioning

confidence: 99%

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Recombinant Virus-like Particle Protein Vaccines

Sitrin¹,

Zhao

Potter

et al. 2014

Vaccine Analysis: Strategies, Principles, and Control

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Section: Release Strategy and Potencymentioning

confidence: 99%

Section: Release Strategy and Potencymentioning

confidence: 99%

Section: Release Strategy and Potencymentioning

confidence: 99%

See 1 more Smart Citation

Recombinant Virus-like Particle Protein Vaccines

Sitrin¹,

Zhao

Potter

et al. 2014

Vaccine Analysis: Strategies, Principles, and Control

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“…The second plenary session addressed methods that have been accepted and methods that are in development that do not require the use of animals for assessing the potency of vaccines [17,18,19,20]. This was followed by breakout sessions to discuss the state of the science and recommendations for future progress for in vitro potency tests for human and veterinary vaccines.…”

Section: Goals and Organization Of The Workhopmentioning

confidence: 99%

“…Significant time and resources are required for each of the above priority vaccines because of (1) the complexities associated with moving from an in vivo test method to one that does not use animals and (2) the significant costs associated with the research, development, and validation of in vitro vaccine potency test methods [18,20]. Therefore, workshop participants strongly encourage early and frequent interactions with regulators throughout this process to maximize the likelihood of a final design that will be accepted by regulatory authorities and to avoid any unnecessary delays.…”

Section: Knowledge Gaps and Priority Research Development And Validmentioning

confidence: 99%

Non-animal replacement methods for human vaccine potency testing: state of the science and future directions

McFarland¹,

Verthelyi²,

Casey³

et al. 2011

Procedia in Vaccinology

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NICEATM and ICCVAM convened an international workshop to review the state of the science of human and veterinary vaccine potency and safety testing methods, and to identify opportunities to advance new and improved methods that can further reduce, refine, and replace animal use. This report addresses methods and strategies identified by workshop participants for replacement of animals used for potency testing of human vaccines. Vaccines considered to have the highest priority for future efforts were (1) vaccines for which antigen quantification methods are already developed but not validated, (2) vaccines/components that require the largest number of animals, (3) vaccines that require an in vivo challenge test, and (4) vaccines with in vivo tests that are highly variable and cause a significant number of invalid tests. Vaccine potency tests identified as the highest priorities for replacement were those for diphtheria and tetanus, pertussis (whole cell and acellular), rabies, anthrax, polio vaccine (inactivated) and complex combination vaccines based on DT or DTwP/aP. Research into understanding the precise mechanism of protection afforded by vaccines and the identification of clinically relevant immunological markers are needed to facilitate the successful implementation of in vitro testing alternatives. This report also identifies several priority human vaccines and associated research objectives that are necessary to successfully implement in vitro vaccine potency testing alternatives.

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