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The Developing Countries Vaccine Manufacturing Network (DCVMN) coordinated a study to assess the feasibility of a serological test--the pertussis serological potency test (PSPT)--to control the potency of the active whole-cell pertussis (wP) component in vaccines. The test was performed by seven wP vaccine manufacturers, and three national control laboratories responsible for the national release of these vaccines. The multilaboratory study was funded by the United States National Institute for Innovation in Manufacturing Biopharmaceuticals. All laboratories shared common protocols for immunizing mice and for testing mouse sera by enzyme-linked immunosorbent assay (ELISA). Each laboratory used its own wP vaccines and the reference vaccine routinely used in the mouse protection test (MPT), which is required by regulatory authorities. All products were tested using the MPT and PSPT. While in all laboratories the PSPT showed a decrease in serum IgG levels in mice after immunization with subpotent batches of the wP vaccine compared to potent batches, some problems were encountered while carrying out the test, which prevented definitive conclusions being made on the test performance. However, the study provided participants with the opportunity to familiarize themselves with the PSPT protocols and indicated the next steps to be addressed to implement this test. Keywords: pertussis vaccine; vaccines, combined; serologic tests; enzyme-linked immunosorbent assay; feasibility studies; animal testing alternatives., 1. Introduction Since 1959, when Russel and Burch published their recommendation introducing the principle of the 3Rs (replacement, reduction and refinement) for the use of animals for scientific purposes, animal [...]

OBJECTIVE--Increased oxidative stress (OS) and impaired anti-OS defenses are important in the development and persistence of insulin resistance (IR). Several anti-inflammatory and cell-protective mechanisms, including advanced glycation end product (AGE) [...]