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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.

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PROVEN RESULTS—THE GPEX® ADVANTAGE

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.

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DIVERSE SOLUTIONS FOR COMPLEX ENDEAVORS

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.
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GPEX® LIGHTNING, THE FUTURE OF RAPID CELL LINE DEVELOPMENT

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
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THE GPEX® LIGHTNING WORKFLOW

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.

  1. Dock Cell Line Creation: Engineered host cells with strategically placed recombination sites.
  2. Targeted Gene Integration: Site-specific integration and universal targeting vectors streamlined in a single transfection step, despite molecular complexity.
  3. Selection & Expansion: Enrichment of high-expressing pools through an innovative selection process.
  4. 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.

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