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Catalent Biologics has launched its new cell line expression technology, GPEx Lightning, which aims to shorten drug substance development timelines by up to three months.
On July 22, 2021, Catalent announced the launch of its next-generation cell-line development technology, GPEx Lightning, which combines innovative technologies, including a novel gene insertion technology, to further shorten drug substance development by up to three months compared to previous timelines.
The benefits of the GPEx cell line expression system 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, which can provide high yielding cell lines while reducing development steps. This reduction in steps can potentially save six to 12 weeks of development 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,” said Mike Riley, region president, Biologics, North America, Catalent, in a company press release. “We continue to develop innovative offerings from cell line development through to CGMP [current good manufacturing practice] manufacturing to enable accelerated timelines with the highest level of rigor and quality.”