While traditional drugs are usualy small molecules, biopharmaceuticals, like proteins, plasmid DNA, viruses or virus-like particles, are large complex bioparticles, with heterogeneus physicochemical properties, sensitive to the environmental conditions (pH, I) and shear forces. Therefore, during manufacturing process of biological nanoparticles there are several issues which have to be considered. To satisfy the severe requirements placed on the purity of biopharmaceutical products demanding several-step purification processes have to be developed. An integral part of downstream processing is the chromatographic unit operation. To gain as high productivity as possible chromatographic resin should exhibit high dynamic binding capacity and high purification yield meaning high selectivity and low degradation of target macromolecule should be achieved preferably at high linear velocity and low pressure drop. Convection-based transport is an extremely important feature that accelerates the separation and purification process, especially of large biomolecules with low mobility. In recent years chromatographic monoliths, also called Convective Interaction Media (CIM), appeared as a resin of choice for biopharmaceutics’ purification. Their specific porous structure enables the convective mass transport and high surface accessibility to large molecules. Therefore they allow very fast separations and exhibit very high binding capacities for extremely large bioparticles. In this work key features of large biological nanoparticles that influence the downstream process of target compound will be discussed. The differences between classical matrixes for liquid chromatography and for biochromatography will be exposed and case studies of several biopharmaceuticals of different classes using special monolithic chromatography columns will be presented.
Presenting author:
Nika Lendero Krajnc
BIA Separations d.o.o., Mirce 21, Ajdovscina, SI-5270, Slovenia
This email address is being protected from spambots. You need JavaScript enabled to view it.
Authors:
Nika Lendero Krajnc - BIA Separations d.o.o., Mirce 21, Ajdovscina, SI-5270, Slovenia
