GPEx® Cell Line Development Platform
SPEED TO THE CLINIC, WITHOUT COMPROMISE
In today’s fast-moving biopharma landscape, developers are under constant pressure to accelerate timelines, control costs, and deliver results without compromising quality. Our GPEx® Cell Line Development Platform meets that challenge, offering an innovative, faster path to clinical material.
Designed as a high-performance mammalian cell line development service, it’s purpose-built to support complex, hard-to-express molecules. With proven performance and flexibility, GPEx® helps you make earlier decisions, compress development cycles, and move confidently toward first-in-human trials.
| 20 | 160+ |
|---|---|
| Commercially approved/authorized products use GPEx® technology | Clinical trials with therapeutic candidates developed utilizing GPEx® technology |
| 160+ | 600+ |
| Different recombinant protein-producing cell lines developed | Different antibodies and antibody fusions successfully produced |
GPEx® technology delivers titers of up to 15 g/L for standard monoclonal antibodies, maintaining expression stability for over 60 generations. By generating stable pools from the outset—without the need for antibiotics, MSX, or MTX selection—our GPEx® Cell Line Development service removes stability testing from the critical path to accelerate your development timelines.
We offer flexible, end-to-end mammalian cell line development services powered by GPEx®, GPEx® Boost, and GPEx® Lightning—built to meet the needs of early discovery through commercial readiness.
| GPEx® | GPEx® Boost | GPEx® Lightning |
|---|---|---|
| Streamline cell line development with GPEx®, using retrovector technology for near 100% transduction efficiency. Create stable clonal lines without selection markers across Chinese hamster ovary (CHO), HEK293, PER.C6, CAP, and other mammalian systems. | Maximize protein yield with GPEx® Boost. Combine GPEx® with CHOZN® glutamine synthase (GS) knock-out CHO cell line* to boost titers up to 4x, improve cell viability, and support ADC development while retaining the proven stability and scalability of the original platform. | Cut development timelines by up to 3 months by integrating proven gene expression technology, GS knock-out CHO cells, and a novel gene insertion method—eliminating time-consuming steps while maintaining high yield, stability, and consistency. |
Unlock faster timelines, higher titers, and superior performance—all with a platform designed to simplify and accelerate your path from gene to clinic.
Ultra-Rapid Cell Line Development
- Parental dock cell line screened for manufacturability and scalability
- Achieve stable, high-yielding cell pools within 40 days of transfection, reducing traditional timelines by 50% or more.
- Enables seamless transition from pool-based production to clonal selection by up to 3 months, with consistent product quality, and accelerated track to First in Human (FiH).
High-Titer Expression
- Delivers titers of 4–15g/L in generic fed-batch production.
- High transgene integration efficiency with 100+ dock sites strategically placed in transcriptionally active regions of the genome.
- Supports robust scalability for both early and late-phase development.
Superior Genetic Stability with Non-Viral Integration
- Targeted recombination technology provides a non-viral approach to gene insertion, ensuring a robust and scalable process.
- Stable expression over 60+ generations, ensuring long-term consistency in product titer and quality.
- Stability taken off the critical path due to consistency observed across protein modalities.
Enhanced Protein Quality and Consistency
- Maintains glycosylation patterns and protein integrity between pools and clones.
- Pool-to-clone consistency provides early indication of performance and quality, reducing the need for extensive screening of clones
- Dial in expression and optimize protein quality of multi-specifics and difficult to express proteins with this tunable system
- Optimized for diverse biologics, including monoclonal antibodies, Fc-fusion proteins, and other complex molecules
GPEx® Lightning leverages targeted recombination technology to rapidly integrate genes of interest into specific genomic locations. This ensures high, stable expression levels while eliminating the variability seen in random integration methods.
- Dock Cell Line Creation: Engineered host cells with strategically placed recombination sites.
- Targeted Gene Integration: Site-specific integration and universal targeting vectors streamlined in a single transfection step, despite molecular complexity.
- Selection & Expansion: Enrichment of high-expressing pools through an innovative selection process.
- Production & Stability Testing: Seamless scale-up with robust stability and expression profiles. Established manufacturing process from early cell line development to GMP.
Applications
- Preclinical & Clinical Biologics Production: Speed up timelines for early-phase toxicology studies and clinical material generation.
- Monoclonal Antibody & Complex Protein Expression: Specifically designed to address next-generation multispecifics as well as traditional antibodies.
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SEAMLESS GENE TO GMP MANUFACTURING
From IND-enabling material to late-stage production, GPEx® Lightning delivers speed, stability, and yield at every stage. Available as a service or in-house license, it enables early partnership from lead selection through commercial scale. With centralized gene-to-GMP capabilities and decades of proven expertise, Catalent provides seamless, end-to-end support for your path to market.