Faster, cheaper and under control: de-risking CMC development with
transposon-derived manufacturing cell lines
Abstract
The development of highly productive, genetically stable manufacturing
cell lines is on the critical path to IND filing for protein based
biologic drugs. Here we describe Leap-In Transpoasase® platform, a novel
transposon-based mammalian (e.g. CHO) cell line development system that
produces high titer stable pools with productivity and product quality
attributes that are highly comparable to clones that are subsequently
derived therefrom. The productivity distributions of clones are strongly
biased towards high producers and both genetic and expression stability
is consistently high. By avoiding the poor integration rates, concatemer
formation, detrimental transgene recombination, low average expression
level, unpredictable product quality and inconsistent genetic stability
characteristic of non-homologous recombination methods, Leap-In provides
several opportunities to de-risk programs early and reduce timelines and
resources.