Gene expression

From gene to clinic and beyond, Catalent Pharma Solutions supports all of your mammalian cell line engineering and biomanufacturing needs:

• From cDNA to a stable, high-yielding mammalian cell line is typically achievable in less than five months
• Research-scale protein production in stainless steel bioreactors for process development
• Scale-up to Phase I material in small bioreactors
• cGMP manufacturing of Phase I/Phase II clinical material

GPEx® (Gene Product Expression) technology is a Catalent proprietary technology that offers several distinct advantages over other conventional gene insertion methods including:

• Gene insertion by transducing your cDNA into virtually any mammalian cell line
• Unique technology/IP for producing monoclonal antibodies (mAbs)

Signature advantages of GPEx® technology are:

Faster timelines- From cDNA to milligram quantities of protein within three months from cDNA to MCB candidate in 4.5 months

Better performance- Higher expression levels and stability

Increased flexibility- Cell lines for protein analysis through commercial manufacturing

Minimal use of serum and selectable markers- Cell lines are developed in protein-free culture media. No antibiotic selection requirement at any point in the cell line engineering or manufacturing process. Testing and production regimen designed to meet stringent regulatory requirements for the production of therapeutic proteins.

Unmatched versatility- No need for selectable markers; GPEx® technology facilitates additional transductions to increase copy number or to add other complementary genes. Choose virtually any mammalian cell type. Single-gene or multigenic expression applications. Demonstrated success with a wide variety of proteins.

Whether you need to distinguish between multiple protein or monoclonal antibody variants increase expression, quickly construct a Master Cell Bank (MCB) or start clinical trials as soon as possible you can rely on Catalent GPEx® technology as an ideal solution for your production challenges.

For capabilities that meet your needs, and outcomes that exceed your expectations, call Catalent today. For more information, please fill out our contact us form or call a member of our sales staff at +1 866.720.3148.