Procrystal

PROCRYSTAL’s specific research objectives (ROs) are:

RO1: to improve the robustness of biomolecules crystallisation, by developing methodologies to enhance nucleation and crystal size control and identifying key process parameters.

RO2: to develop crystallisation platforms with integrated diagnosis tools that can meet shifting demands of scale and product diversity.

RO3: knowledge-based assessment and digital tools to assist process design and control.

RO1: to improve the robustness of biomolecules crystallisation, by developing methodologies to enhance nucleation and crystal size control and identifying key process parameters.

RO2: to develop crystallisation platforms with integrated diagnosis tools that can meet shifting demands of scale and product diversity.

RO3: knowledge-based assessment and digital tools to assist process design and control.

Critical insights into biomolecules nucleation control (WP1) and process design (WP2) are provided through experimentation in scaled-down platforms with advanced PAT tools (WP3), assisted by modelling.

All the gathered information will feed the development of a technical process strategy decision and life-cycle assessment of the developed methods and tools (WP3), that in turn can provide new insights into the fundamentals and systems investigated in WP1 - WP3.

WP1 - Nucleation control strategies

WP1 aims to investigate methodologies towards biomolecules (mAbs and peptides) nucleation control, determinant of crystals’ properties (size, crystal size distribution-CSD, polymorph), to design robust crystallisation processes, while maximising biomolecule stability and minimising biomolecule aggregation.

WP2 - Process design

WP2 aims to build the knowledge framework to design crystallisation processes for biopharmaceuticals (mAbs and peptides). For this, systematic study of the influence of process parameters on crystallisation kinetics (nucleation and growth rate) and crystals’ properties (size, CSD, polymorphism, purity) is conducted in scaled-down platforms coupled to PAT tools. The experimental work is assisted by in silico and numerical approaches to enable process design, optimisation and control.

WP3 - Technology development and Decision & assessment

WP3 deals with the development of innovative screening platforms and usable facilities to investigate process transfer from the laboratory scale to pilot scale, coupled to PAT tools. The take up of the developed technologies depends on demonstrating the process capability and the associated environmental burdens.

WP1 - Nucleation control strategies

WP2 - Process design

WP3 - Technology development and Decision & assessment