How the bioanalyst plays a key role in interdisciplinary project teams in the development of biotherapeutics – a reflection of the European Bioanalysis Forum

The role of the bioanalyst within project teams developing biotherapeutics, is not well-understood. Thus, the goal of this manuscript is to enhance the understanding of bioanalytical needs from the different project team functions. The ideas presented here come from an EBF (European Bioanalysis Forum) topic team assigned by the EBF steering committee to elucidate the challenges of total and free macromolecule quantification. This topic team started their activities in 2011 following up on the publication of the White paper by Lee et al (1) and held a break-out session at the EBF Open Symposium in Barcelona in November 2011 where all speakers agreed on the importance of inter-disciplinary communication between bioanalysts and data end-user in bringing forward understanding of the challenges faced by both sides(2)