Shortening the Biologics Clinical Timeline with a Novel Method for
Generating Stable, High Producing Cell Pools and Clones
Abstract
Reducing drug development timelines is an industry-wide goal to bring
medicines to patients in need more quickly. This was exemplified in the
COVID-19 pandemic where reducing development timelines had a direct
impact on the number of lives lost to the disease. The use of drug
substance produced using cell pools, as opposed to clones, has the
potential to shorten development timelines. Toward this goal, we have
developed a novel technology, GPEx® Lightning, that allows for rapid,
reproducible, targeted recombination of transgenes into more than 200
Dock sites in the CHO genome. This allows for rapid production of high
expressing stable cell pools and clones that reach titers of 4 to 12 g/L
in generic fed-batch production. These pools and clones are highly
stable in both titer and glycosylation, showing strong similarity in
glycosylation profiles.