Cell Line Development
Generation of stable, high-performance cell lines using GPEx technology
Our GPEx® technology is based on a proprietary, pseudo-typed, high-performance vector that generates high-performance, highly stable, production cell lines in a wide variety of mammalian host cells, including; CHO-S, CHO-K1, CHO-DG44, HEK293, CAP and others. Virtually any cDNA (mAb and multigenic applications) can be packaged into the GPEx® retrovector and used to transduce your choice of mammalian cell line. To date, over 460 different mAb and mAb fusions and over 50 different recombinant proteins have been produced using the GPEx® system achieving large scale fed-batch production titers of over 7.0 g/L (CHO-S) and 2.5 g/L (HEK293).
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.
Single and Multigenic Applications
- Monoclonal antibody (mAb) heavy- and light-chain co-expression
- Receptors, co-expressed with a secreted surrogate
- Inactive proteins, co-expressed with associated processing enzymes
- Sequential transduction can be used to introduce required genes without antibiotic selection
- Expression can be enhanced by clonal selection or additional rounds of transduction without antibiotic selection
- Productivity from 50 to over 100 picograms per cell, per day
- Final titers up to 7 gm/L in fed-batch bioreactor systems
- Stability demonstrated up to 100 generations. No need for selectable markers
- From cDNA to 100s of milligrams of protein from early cell pool
- Rapid production of a Master Cell Bank (MCB)
- Stable pools are generated from the outset and removes stability testing from the critical path
- Proven Technology
- 7 commercially marketed biosimilar mAbs use GPEx Technology
- 2 products in US/EU Phase III trials
- 460+ different antibodies / antibody fusions
- 50+ different recombinant proteins
- 30+ ongoing clinical trials
- 40+ current clients / with over 80 active projects
Catalent Cell Culture Services
- Feasibility Studies: Reflecting your product development plan and leading to cell bank production, cell culture manufacturing, and purification process development.
- Product Lead Screening: Production of small quantities of lead product candidates in manufacturing platform enabling time saving product quality screening assessment.
- High Performance Stable Production Cell lines: Initial protein product in four months and MCB candidate in 4.5 months