The technology is capable of shortening drug substance development timelines by up to three months, the company claims
Catalent, a provider of delivery technologies, development, and manufacturing solutions for drugs, biologics and cell and gene therapies, has announced the launch of its next-generation cell line development technology, GPEx Lightning. Leveraging the company’s GPEx expression platform in a glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line system, the technology combines technologies, including a gene insertion technology, to shorten drug substance development.
The company’s proprietary GPEx suite of technologies have been used in 13 commercial products to date, and there are more than 125 ongoing clinical trials with therapeutic candidates developed using the technology. Its features include titers of up to 10 g/L for traditional monoclonal antibodies, with no need to test for genetic stability, Catalent says.
“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. “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.”
The portfolio of GPEx technologies, including original GPEx, Boost, and now Lightning, allow customers to tailor a cell line engineering approach to best meet their specific program needs, the company claims.
Catalent Biologics’ Madison, Wisconsin facility is home to GPEx technology and provides development, manufacturing, and analytical services for new biological entities and biosimilars. The facility was designed for clinical and commercial cGMP production, from 100 to 4,000 L scale. The site recently added its fourth and fifth manufacturing trains, each with a 2x2,000 L single-use bioreactor system capable of processing batches of 2,000 L or 4,000 L.
As part of the launch, Gregory Bleck, Ph.D., VP, R&D, Catalent Biologics, will present the latest GPEx Lightning data during PEGS Summer Symposium, which is taking place as a virtual event from July 19-22, 2021.