As single-use technologies have grown in importance and acceptance, offering more solutions every year, their biggest challenges have come in downstream separation, purification, and processing that follows product expression in cell culture. Many technologies in downstream processing present technical and economic problems. BioProcess International magazine has produced a featured report that delves into many of these issues and innovations. They discuss automation, depth filtration, continuous processing, alternatives to resin chromatography, and fill and finish technology.
In the drive for reduced costs and more economical manufacturing of biopharmaceuticals, alternatives to resin chromatography are being examined. One article in the featured report focuses on the use of membrane adsorbers. Here, we provide an excerpt of Membrane Adsorbers, Columns: Single-Use Alternatives to Resin Chromatography:
Chromatography resins are inherently disadvantaged by diffusion limits of the pores in chromatography media. Therefore, resin columns must be significantly oversized to match the performance of high productivity bioreactors.
By comparison, membrane adsorbers take advantage of filter performance to deliver highly productive downstream operations. Surface-functionalized membranes from Sartorius Stedim Biotech (Sartobind Q, STIC) and Pall Life Sciences (Mustang Q)typically use anion-exchange groups for MAb polishing operations in negative mode (in which trace impurities are removed without binding the protein of interest).
Such flow-through chromatography operations for impurity reduction can enhance purification productivity by over an order of magnitude: from ≤250 g/L capacity (~250 g/L-h productivity for 10 g MAb/L and two minutes residence time representing one hour operation) for chromatography resins to ≤10,000 g/L capacity (~5,000 g/L-h productivity for 10 g MAb/L and six seconds residence time representing two hours operation) for membranes.
Read the entire Downstream Processing Single-Use Technology Featured Report now.