Our staff members have contributed to a number of scientific publications before and during their association with Coriolis. This combined knowledge is the backbone of our scientific excellence. If you are interested in reprints of the publications, please feel free to contact us.
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Eur J Pharm Biopharm. 2014 Nov;88(3):919-30. doi: 10.1016/j.ejpb.2014.09.004. Epub 2014 Sep 28 (2014)
Scalable organic solvent free supercritical fluid spray drying process for producing dry protein formulations
Nuchuchua O , Every HA , Hofland GW , Jiskoot W
In this study, we evaluated the influence of supercritical carbon dioxide (scCO2) spray drying conditions, in the absence of organic solvent, on the ability to produce dry protein/trehalose formulations at 1:10 and 1:4 (w/w) ratios. When using a 4L drying vessel, we found that decreasing the solution flow rate and solution volume, or increasing the scCO2 flow rate resulted in a significant reduction in the residual water content in dried products (Karl Fischer titration). The best conditions were then used to evaluate the ability to scale the scCO2 spray drying process from 4L to 10L chamber. The ratio of scCO2 and solution flow rate was kept constant. The products on both scales exhibited similar residual moisture contents, particle morphologies (SEM), and glass transition temperatures (DSC). After reconstitution, the lysozyme activity (enzymatic assay) and structure (circular dichroism, HP-SEC) were fully preserved, but the sub-visible particle content was slightly increased (flow imaging microscopy, nanoparticle tracking analysis). Furthermore, the drying condition was applicable to other proteins resulting in products of similar quality as the lysozyme formulations. In conclusion, we established scCO2 spray drying processing conditions for protein formulations without an organic solvent that holds promise for the industrial production of dry protein formulations.
Copyright © 2014 Elsevier B.V. All rights reserved.