Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced the launch of its 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.”
For 20 years, Catalent’s proprietary GPEx suite of technologies have created stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies to clinical and commercial-scale manufacturing. The portfolio of GPEx technologies, including original GPEx, GPEx Boost, and now GPEx Lightning, will allow customers to tailor a cell line engineering approach to best meet their specific program needs.
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 flexible clinical and commercial CGMP production, from 100 to 4,000-liter scale. The site recently added its fourth and fifth manufacturing trains, each with a 2×2,000-liter single-use bioreactor system capable of processing batches of 2,000 liters or 4,000 liters. The new suites add to an existing 2×2,000-liter suite, a 1,000-liter suite and a 500-liter suite.
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. On Thursday, July 22 at 10:15 a.m. EDT, Dr. Bleck will present “Introducing GPEx Lightning: Leveraging Proven Technology to Speed Your Path to First-In-Human Studies,” where he will debut the technology and share timeline, titer and cell culture data. For more information on this event, visit www.catalent.com/events/pegs-virtual-summer-symposium/.