Cell Line Development

Home

Biologics

Drug Substance

GENERATION OF STABLE, HIGH-PERFORMANCE CELL LINES USING GPEX TECHNOLOGY

GPEx Advantages How GPEx Works Videos

GPEx® cell line development technology is a proven technology that generates high-performance, highly stable, production cell lines. Virtually any cDNA (mAb and multigenic applications) can be inserted into cells. To date, over 600 different mAb and mAb fusions and over 80 different recombinant proteins have been produced using the GPEx® system, with 125+ ongoing clinical trials utilizing therapeutic candidates developed using GPEx® technology and 15 commercially-approved products.

GPEX ADVANTAGES

Reliability

Up to 10 g/L titer for standard mAbs
Stability demonstrated up to 100 generations. No need for antibiotic, MSX or MTX selection
Stable pools are generated from the outset and removes stability testing from the critical path.

Proven Technology

15 commercially approved products use GPEx® technology
125+ ongoing clinical trials with therapeutic candidates developed utilizing GPEx® technology
600+ different antibodies/antibody fusions
80+ different recombinant proteins

HOW GPEX WORKS

GPEx® technology uses a retrovector technology that ensures the stable transduction of targeted cells, approaching 100% efficiency. This level of efficiency eliminates the requirement for selectable markers, and stable clonal cell lines are produced rapidly. GPEx technology utilizes additional transductions to increase copy number or to add other complementary genes. GPEx Boost or GPEx Lightning can provide speed and high titer for proteins expressed in CHO cells. For those in non-CHO cells, original GPEx® technology enables high-performance and highly stable production cell lines in CHO, HEK293, PER.C6, CAP and a variety of other mammalian cells.

GPEX BOOST

Building on years of proven expertise, Catalent has further optimized its GPEx® cell line technology to develop GPEx® Boost, the next generation in cell line development. The technology combines Catalent’s proven GPEx® expression platform with the CHOZN® glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line* to improve the ability of cells to produce high titers and increase specific productivities of a protein of interest.

Benefits:

Up to four-fold higher titers in difficult-to-express proteins
Reduced ammonia build up leading to improved cell growth and viability
Can be used with SMARTag® bioconjugation technology for development of antibody-drug conjugates (ADCs)
Commercially-approved and industry-accepted GPEx® and GS knock-out technologies
Same stability benefits as enjoyed with original GPEx® technology.

GPEX LIGHTNING

Combines GPEx technology, the GS knock-out CHO cell line system and a novel gene insertion technology to further shorten drug substance development by up to three months. The GPEx Lightning platform combines these unique technologies into one process to provide the same benefits of GPEx while enabling time-consuming steps to be removed from the critical path.

Benefits:

Six to twelve weeks time savings on development timelines
Non-viral gene insertion technology
Antibody pool titers up to 8 g/L
Fc fusion pool titers at 4+ g/L and recombinant protein pool titers at 3+ g/L.

Note: GPEx and SMARTag are registered trademarks of Catalent, Inc. or its affiliates or subsidiaries.

* Catalent has licensed the CHOZN® GS cell line from Merck KGaA, Darmstadt, Germany or its affiliates. CHOZN® is a registered trademark of Merck KGaA, Darmstadt, Germany or its affiliates.