New chromatography technologies for the purification of biological therapeutics.
John M. Jenco, Ph.D.
Senior Principal Scientist
Technical Services Group
Pall Life Sciences
Port Washington, NY, USA
The upstream production process for all biological therapeutics begins with a crude
feedstock containing not only the target molecule of interest but a variety of background
contaminants as well. These crude feedstocks come from many sources including:
plasma; fermentation of genetically engineered bacteria, yeasts, and mammalian cells;
transgenic milk; and even the leaves or seeds of genetically engineered plants. The
demand for antibodies, therapeutic proteins, and gene therapy products is increasing, and
the rising production levels from the upstream side are putting greater demands on the
downstream purification process. The challenge for each purification step is two-fold: 1)
to consistently reduce and/or eliminate common contaminants (proteins, nucleic acids,
viruses, and endotoxin) that would otherwise cause adverse reactions in patients; and 2)
to consistently produce high yields of valuable target. Multiple chromatographic steps
are routinely used to address the removal of contaminants through several orthogonal
mechanisms. Hypercel mixed mode chromatography, Hypercel and Ceramic HyperD®
ion exchange chromatography, and Mustang® membrane chromatography represent
significant improvements in downstream purification in terms of capacity, recovery, and
throughput, and are key tools that contribute to producing robust yields of pure biological
therapeutics. These chromatography technologies play an important role in reducing the
high levels of contaminants encountered from the upstream process to the low levels
required by regulatory authorities in the final formulated product. The risk of adverse
events is mitigated, and patient safety is not compromised.