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Optimising validation studies of non-animal methods for vaccine testing

ELISA – Enzyme-linked immunosorbent assay to measure antibodies or antigen
©European Union 2018
May 03 2018

New report summarises the outcome of a workshop organised by the Joint Research Centre's EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) and VAC2VAC* partners on the design of multi-centre validation studies.

The VAC2VAC project aims to develop and validate non-animal based methods for the quality control of vaccines. In order to incorporate a new method into a monograph or a guideline used for regulatory purposes, the method has to be shown to be reproducible and to have the ability to detect vaccine batches of insufficient quality.

Moreover, any new method introduced for the quality control of a vaccine needs to undergo product-specific validation. In the light of this, workshop participants coming together in early 2017 discussed ways of optimising the design of validation studies and making use of the data generated for product-specific validation purposes.

Recommendations encourage manufacturers to play a more active role by identifying suitable non-animal methods, providing relevant samples, or by sponsoring of studies.

Since multi-centre validation studies and product-specific validation are technically demanding and time and resource intensive, availability of sufficient resources for validation studies and implementation of new methods is crucial. Moreover, the availability of critical reagents and reference preparations should be secured.

There are several new documents available or under development which support the substitution of animal tests for the quality control of vaccines and the use of data generated in multi-centre validation studies for product-specific validation.

A number of the recommendations are addressed to the VAC2VAC project itself and will be followed up by the partners.

Read more in: M. Halder et al.: Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies Biologicals 52 (2018) 78–82

* VAC2VAC - Vaccine batch to vaccine batch comparison by consistency testing. The VAC2VAC project receives funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement N- 115924. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.

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