The general concept consists in using affinity chromatography applied to the highly demanding field of vaccine production. The partners will combine two major nanotechnology innovations (Nanofitin® ligands for affinity capture and Aquaporin Inside™ membranes for fluid recycling) to develop an integrated purification platform amenable to diverse, heterogeneous types of vaccines : glycoconjugates, protein antigens and viruses.
GSK brings to the consortium a broad range of representative targets that are actual vaccine candidates and will ensure along the way that purification processes developed under DiViNe project meet industrial needs and expectations.
Nanofitins® will be discovered by Affilogic and selected for their ability to release the vaccine targets under mild elution conditions, not hampering their integrity. Further engineering of the Nanofitins® will enable enhanced capture performances of the affinity material.
Merck KGaA will provide the chromatographic materials and coupling technologies to immobilize the Nanofitin® affinity ligands. The most promising materials will be optimized regarding dynamic binding capacity, operational stability, and process economical aspects.
Membrane purification of water with Aquaporin Inside™ membranes is currently applied to cleantech but not to pharmaceuticals. Aquaporin will implement its technology for water recycling and reusability in a much more demanding area in terms of purity and controls.
iBET is Project Coordinator as well as responsible for the whole process validation, including QC and up- and downstream integration. The synthesis of the final prototypes will be scaled up into multi-Liter scale.
GenIbet Biopharmaceuticals will perform all required QC testing and be responsible for cGMP manufacturing compliance. Taking into account quality and regulatory requirements, they will identify a path to valid this global, compliant, environment-friendly process for vaccines manufacturing.