Development of semi-continuous chromatography in the production of therapeutic proteins & vaccines to reduce costs, increase productivity and avoid any bioburden. – Techlockbioprocess

The proposed project concerns the development of new processes for purification therapeutic proteins & vaccines derived from bioproduction in order to increase the efficiency, reduce the cost of production of biomolecules (in terms of process time, resin cost, volumes of buffers and cleaning in place) and eliminate the risk of bioburden and cross contamination. These improvements of performance concerning productivity and buffer/resin consumption should not be obtained at the detriment of the quality of the purified biomolecule and process yield.
The development of the process concerns the modification of the semi-continuous chromatography concept already developed by NOVASEP (called BioSC for Bio-Sequential- Chromatography) for downstream bioprocessing; and its validation in terms of yield, purity, contaminants removal but also coupling the bioreactor with semi-continuous chromatography through biomass /media separator positioned between the bioreactor and chromatography. This system minimizes dead time and will increase stability and product quality and reduce the process time and costs. For this, it must be taken into account the specific constraints associated with biotechnological processes in terms of contaminant removal from the producing cells (aggregates of the molecule of interest, host cell proteins, DNA, endotoxin, virus), processes leachable and also constraints from sanitization and validation aspects. The technological barrier is overcome to allow this process to be recognized as a reliable bioprocess and therefore increase significantly the competivity in terms of production costs and allows production of biopharmaceuticals with limited stability. Semi-continuous chromatography will be compared at each step of the purification process with discontinuous chromatography (referred to in the following as classical or batch chromatography).
In parallel and in collaboration with the Laboratory Partner 1, see below), the industrial company (Partner 2) will improve the current apparatus (BioSC) and addresses several points such as: ease of use, robustness, on-line control, cleanability and disposability to eliminate bioburden & cross contamination. All these points will be improved in collaboration with the Laboratory in a feedback transfer of information from experiment results and observations exchanged by the Partners. This will make it possible to be in line with industrial needs and meet the regulatory constraints. The economical impact will be evaluated to demonstrate the possible gains with this technology.