Our GPEx® technology generates stable mammalian cell lines.
The GPEx retrovector technology is a proprietary pseudotyped, high-titer vector, which ensures that stable transductions occur in virtually 100% of target cells (any mammalian cell line). This feature eliminates the need for selectable markers, saving time and cost. Compare the technological advantage of the GPEx technology system to conventional transfection or electroporation methods that can produce an insertion frequency as low as 1 out of every 100,000 cells, necessitating additional selection steps and selectable marker genes. Other methods carry the risk of gene excision or silencing, making them relatively unstable.
Virtually any cDNA (see mAb and multigenic applications) can be packaged into the GPEx retrovector and used to transduce your choice of mammalian cell line. This technology typically produces a stable clonal cell line in about four months for proof of concept studies. High producing cell lines suitable for Master Cell Banking (MCB) and subsequent cGMP production are typically obtained in less than five months after receipt of your cDNA.
Rapid development
Using conventional gene insertion and expression techniques, developing a stable production cell line for a target protein can take as long as 18 months. GPEx overcomes the inefficiencies of conventional systems and delivers a stable production cell line for your target protein in as little as 4.5 months.
Increased yield
The GPEx gene insertion technology produces mammalian cell lines - typically CHO cells - that deliver higher initial yields of proteins than any conventional system based on transfection or electroporation.
One reason for higher yields is that the GPEx retrovector targets high-expressing chromosomal matrix attachment sites in the target cell genome, leading to markedly higher expression of the gene in transduced cells compared with other systems. Another important reason is that the optimization of GPEx cell lines employs an iterative insertion process that drives up the inserted gene copy number and proportionally increases protein expression levels. The optimized cell line may therefore have a dozen or more copies of the desired gene, all stably inserted and expressing the target protein.
Better flexibility and unmatched versatility
- Monoclonal antibody heavy- and light-chain coexpression
- Receptors, coexpressed with a secreted surrogate
- Inactive proteins, coexpressed with associated processing enzymes
- Sequential transduction can be used to introduce required genes without antibiotic selection
- Expressions can be enhanced by clonal selection or additional rounds of transduction without antibiotic selection
Program options:
- Cell line development:
- Initial protein product in four months and MCB candidate in 4.5 months.
- Process development:
- Cell line optimization and gram-scale production and purification from small bioreactors.
- cGMP manufacturing:
- Phase I/Phase II cGMP production of clinical trial material.
Catalent Pharma Solutions will design a development program that meets your specific goals. Normally, this begins with a milestone-based feasibility study reflecting your product development plan. The result of this study is typically the production of a stable high-expressing mammalian cell line and gram quantities of protein for your analysis and preclinical needs.
At the conclusion of the feasibility study you can out-license the cell line for production at the facility of your choice, or continue to work with Catalent. We can manufacture cGMP product for Phase I/Phase II clinical trials at our Middleton, Wisconsin facility.
For capabilities that meet your needs, and outcomes that exceed your expectations, partner with Catalent today. For more information contact us at gpexinfo@catalent.com or call a member of our sales staff at +1 (608) 821.6249.