![]() ![]() 238000004587 chromatography analysis Methods 0.000 claims description 15.230000014759 maintenance of location Effects 0.000 claims description 16.238000005119 centrifugation Methods 0.000 claims description 16.XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 18.238000000108 ultra-filtration Methods 0.000 claims description 21.238000006297 dehydration reaction Methods 0.000 claims description 34.239000011780 sodium chloride Substances 0.000 claims description 40.FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 41 FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound.235000015192 vegetable juice Nutrition 0.000 claims description 45.229920003303 ion-exchange polymer Polymers 0.000 claims abstract description 10.239000003456 ion exchange resin Substances 0.000 claims abstract description 10.238000004519 manufacturing process Methods 0.000 title description 18.239000002028 Biomass Substances 0.000 title claims abstract description 25.238000000034 method Methods 0.000 title claims abstract description 44.108010003581 Ribulose-Bisphosphate Carboxylase Proteins 0.000 title claims abstract description 139.Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) Filing date Publication date Priority claimed from FRFR1907012 external-priority Application filed by Institut National Des Sciences Appliquees De Toulouse, Centre National De La Recherche Scientifique, Institut National De La Recherche Agronomique, Ecole National Superieure Des Mines D'albi-Carmaux, Ovalie Innovation filed Critical Institut National Des Sciences Appliquees De Toulouse Priority to EP20747040.2A priority Critical patent/EP3989731A1/en Publication of WO2020260831A1 publication Critical patent/WO2020260831A1/en Links Inventor Syrine KERFAI Bernard REBOUL Sandrine Alfenore Jacqueline RESENDE DE AZEVEDO Maria Aurora Fernandez Stephane Mathe Maria Angelica USTA Maria-Ines RE Manon MONTANER Original Assignee Institut National Des Sciences Appliquees De Toulouse Centre National De La Recherche Scientifique Institut National De La Recherche Agronomique Ecole National Superieure Des Mines D'albi-Carmaux Ovalie Innovation Priority date (The priority date is an assumption and is not a legal conclusion. Google Patents WO2020260831A1 - Process for the production of rubisco from a plant biomass This method enabled > 90 % overall recovery of unformulated DS at ≥ 150 g/L.WO2020260831A1 - Process for the production of rubisco from a plant biomass Most of the rinse was combined with the retentate to hit the target protein concentration. After the retentate was collected, a minimal volume of buffer was added for the UF rinse. During the UF/DF process, the antibody was initially concentrated to 90 g/L, diafiltered, and concentrated to ≥ 180 g/L, then the retentate was collected. Analysis showed that the Capto S run removed the excipients with yields of ≥ 96%. In addition, Capto S has lower resin costs, takes less time to process, and uses milder elution conditions. A Capto S column was chosen over Protein A chromatography to remove excipients from formulated drug substance because of its higher binding capacity. Fortunately, a sufficient supply of formulated DS was available for reprocessing. Since the pilot plants were not available for large-scale campaigns, a creative alternative was needed to produce 2 kg of antibody from formulated DS for these studies. During process scale-up, the project team decided to make a high-concentration mAb drug substance for subcutaneous injection and change the formulation. ![]() The scope of this work is two-fold: 1) excipients removal from formulated mAb drug substance by Capto S chromatography and 2) UF/DF process development to make high-concentration drug substance (DS) for subcutaneous injection.
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