The Biological Standardisation Programme (BSP) wishes to inform the scientific community that the project coded BSP104 has been brought to a close.

The project aimed at evaluating a replacement method for the in vivo challenge test for the potency control of whole-cell pertussis vaccines (Kendrick test).

The preparatory Phase 1 of the study evaluated two variants of a serological method, the Pertussis serological potency test (PSPT, in guinea pigs and in mice).

The results indicated that product-specific references are required to ensure data parallelism with the tested vaccines. However, the data did not demonstrate sufficient precision and reproducibility nor did they demonstrate reliable discriminatory power.

In the absence of convincing scientific evidence to support a large-scale collaborative trial, the Steering Committee of the BSP recommended not to proceed with further experimental work and decided to discontinue the BSP project. Thus, the EDQM will neither publish nor authorise the publication of data generated in the BSP104 project.

The organisers thank all experts and laboratories involved in this project for their considerable efforts.

The BSP remains open to project proposals on 3R topics for methods that have a demonstrated validation according to ICH Q2. Methods should be transferable, accessible to the full scientific community and potentially suitable for all (or at least several) relevant products on the European market.