Development and optimization of a TNFα neutralizing assay using a Quality by Design approach

Fabian Vandermeers
Capucine Lepers
Florence Dusserre-Bresson
Christelle Plennevaux
Stéphanie Pennincx
Julie Nicaise
Estelle Lara
Arnaud Delobel
BEBPA 2017

Development and optimization steps are of major importance to ensure the delivery of reliable results in the routine use of a bioassay. Quality by Design (QbD) approach requires a combination of thorough knowledge of the scientific background of the assay and the use of proper statistical tools to achieve best results.