Catalent announced the launch of a next-generation cell line development technology, GPEx® Lightning. Leveraging Catalent’s proven GPEx expression platform in a glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line system, GPEx Lightning combines innovative technologies, including a novel gene insertion technology, to further shorten drug substance development by up to three months compared to previous timelines.
Catalent’s proprietary GPEx suite of technologies have been proven in 13 commercial products to date, and there are more than 125 ongoing clinical trials with therapeutic candidates developed using the technology. Benefits of GPEx cell line expression include titers of up to 10 g/L for traditional monoclonal antibodies, with no need to test for genetic stability. The new GPEx Lightning platform combines multiple, advanced engineering technologies into a single process to provide high-yielding cell lines while reducing development steps, offering customers a typical saving of six to twelve weeks on their programs' timelines.
“Speed to clinic is of critical importance to our customers and the patients they serve, and GPEx Lightning builds on a proven platform to accomplish that goal,” commented Mike Riley, Region President, Biologics, North America. “We continue to develop innovative offerings from cell line development through to CGMP manufacturing to enable accelerated timelines with the highest level of rigor and quality.”
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