Technology trends in antibody purification.

Polymethacrylate monoliths for preparative and industrial separation of biomolecular assemblies.

Applications of polymethacrylate-based monoliths in high-performance liquid chromatography.

Manufacturing of cell culture-derived virus particles for vaccination and gene therapy is a rapidly growing field in the biopharmaceutical industry The process involves a number of complex tasks and unit operations ranging from selection of host cells and virus strains for the cultivation in bioreactors to the purification and formulation of the final product For the majority of cell culture-derived products, efforts focused on maximization of bioreactor yields, whereas design and optimization of downstream processes were often neglected Owing to this biased focus, downstream procedures today often constitute a bottleneck in various manufacturing processes and account for the majority of the overall production costs For efficient production methods, particularly in sight of constantly increasing economic pressure within human healthcare systems, highly productive downstream schemes have to be developed Here, we discuss unit operations and downstream trains to purify virus particles for use as vaccines and vectors for gene therapy

https://www.tandfonline.com/doi/pdf/10.1586/erv.11.111

Downstream processing of cell culture-derived virus particles

Developments in the use and fabrication of organic monolithic phases for use with high-performance liquid chromatography and capillary electrochromatography.

Simple method for determining the amount of ion-exchange groups on chromatographic supports

Characterization of ion exchange stationary phases via pH transition profiles.

Chemical and chromatographic stability of methacrylate-based monolithic columns

Chromatographic monoliths exhibit several properties like flow-unaffected resolution and dynamic binding capacity, low pressure drop and high capacity for extremely large molecules, which are advantageous to the purification of large biomolecules such as proteins, DNA or even viruses. Recently, large-volume monolithic columns were introduced enabling the monoliths to be incorporated into industrial downstream processes. Due to the monolithic structure, however, conventional methods for resin characterization cannot be applied to monoliths, which limit their usage under cGMP conditions. In this article, a methodology of how to overcome this problem and to determine the most important parameters is presented. Several fast and noninvasive methods for monolith characterization are introduced. Their usage enables accurate determination of monolith pore size distribution and specific surface area, uniformity of the monolith as well as type and density of the active groups before or during monolith usage.

Nika Lendero

Papers

Simple method for determining the amount of ion-exchange groups on chromatographic supports

Characterization of ion exchange stationary phases via pH transition profiles.

Chemical and chromatographic stability of methacrylate-based monolithic columns

Noninvasive Methods for Characterization of Large‐Volume Monolithic Chromatographic Columns