Amidst stringent regulatory requirements, it is imperative to build quality into biomolecule products and also contain production costs. These needs are efficiently addressed by the Quality by Design (QbD) approach. The QbD framework combines modern tools such as Design of Experiments (DOE), process characterization, Process Analytical Technology (PAT) and risk analysis to ensure product quality and improve process and product development efficiency.

Workshop content:

	An overview of the Quality by Design framework in general and the Design of Experiments methodology in particular, including their benefits related to biomolecule manufacturing
	Efficient workflows utilizing rapid HTPD format screening in combination with column format optimization
	Case study examples from protein purification process development
	Live demonstration of data evaluation, interactive discussions around workflow HTPD screening -> column format optimization Preregistration for the workshop is now closed. Remaining seats on first come basis.