GPEx - Cell Line Development Technology
GPEX ADVANTAGES
Reliability
- Up to 15 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
- 16 commercially approved products use GPEx® technology
- 160+ clinical trials with therapeutic candidates developed utilizing GPEx® technology
- 600+ different antibodies/antibody fusions
- 160+ 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.
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