The process of purification and recovery of biopharmaceuticals, such as vaccines, is generally referred to as “downstream processing”. This process aims at removing the maximum of contaminants while recovering as much of the therapeutic molecule as possible. Currently, this process relies in multiple «negative» selection/purification steps which negatively impact recovery yields while increasing costs and waste products. In contrast, the development of «positive» separation methods like affinity targeted in Divine, could significantly reduce the number of purification steps resulting in faster downstream processes and higher purification yields, leading to a reduction in costs and waste could also be achieved.
Water recycling is a major concern in the vaccine industry, as the aforementioned purification steps result in large volumes of “unclean” water that are directed to Wastewater Treatment Plants. This use of water is of concern for developing countries, as the strategy of pharma industry to build local production plants in an attempt to reduce vaccination cost is significantly impacted by water availability.
The DiViNe project is tackling these vaccine availability and cost and environmental issues with technological solutions. The consortium combines two major Nano/biotechnology innovations to develop an integrated vaccine purification platform, amenable to different types of vaccines, increasing titers, lowering costs and reducing wastewater production.
The consortium is composed of Affilogic, which combines efforts with Merck to generate Nanofitin-based chromatographic columns (novel affinity capture ligands), iBET, developing affinity chromatography for enveloped vaccines and bio-processes to enable a sustainable large scale production of Nanofitins, GSK Vaccines providing the consortium with a broad range of vaccine candidates as targets for purification and who will test the performance of the novel affinity chromatography columns, Aquaporin introducing use water and energy-saving nano-biomimetics based membranes for water decontamination, and Genibet producing under cGMP the intermediate master cell banks.
The custom affinity capture processes being developed as a sustainable platform is therefore economically relevant, in a very large market. Beyond the technical partnership, the project is a first run for the partners to structure the platform as a commercial offer for downstream processing of biologics in particular, biopharmaceuticals.
