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Leadgene Leadgene

 Cell Line Development Service

 

Blueprints for Biologics: Navigating Cell Line Development
  • Leadgene Biomedical provides an end-to-end cell line development solution designed to accelerate biologics research and production.
  • Our fully automated CLD platform — C.STATION — integrates single-cell cloning, high-throughput screening, real-time monitoring, and data analysis to ensure rapid, reliable, and regulatory-ready cell line generation.
  • By combining Leadgene Biosolutions automation with Leadgene’s bioprocess expertise, we reduce the timeline from 6–9 months to just 3–6 months, while maintaining exceptional clonality and product stability.

 

 

 

Key Features

  • Automated & High-Throughput Workflow
    Screen thousands to millions of clones per round, with significant time and labor savings.

  • Double Assurance of Clonality
    UP.SIGHT™ nozzle + 3D well imaging system achieves > 99.99% clonal probability.

  • Precision Data Tracking
    C.STUDIO software automatically records imaging, growth, and titer data, complying with FDA 21 CFR Part 11 requirements.

  • High Productivity and Stability
    CHO-K1Q glutamine synthetase system supports stable high-yield expression (> 100 mg/L in mini-pools).

  • Scalable and Cost-Efficient
    From 96-well to bioreactor production without manual bottlenecks, reducing operational costs over time.

 

 

 

 

From Manual to Automated — Redefining Cell Line Development

 

CLD

Traditional

Leadgene’s Automation Platform

Manpower
  • High manual workload across multiple steps
  • Strong reliance on operator skills and experience
  • Labor-intensive and time-consuming
  • Low manual input with automated systems
  • Software-driven control reduces human variability
  • Fewer skilled personnel needed for monitoring

Time
  • 6–9 months from transfection to RCB
  • Extended optimization cycles delay progress
  • 3–6 months total timeline
  • Integrated workflow accelerates milestone delivery
Quantity / Throughput
  • Tens to hundreds of clones per screening round
  • Limited screening throughput
  • Thousands to millions of clones per screening round
  • High-throughput imaging and analysis

Cost
  • High reagent, labor, and equipment costs
  • Expensive large-scale screening
  • Lower long-term operating cost
  • Reduced reagent usage and hands-on time
Process Stability
  • Highly dependent on manual operation
  • Variable results between batches
  •  Automated, standardized process
  • Consistent and reproducible performance
Screening Efficiency
  • Low – manual testing of expression and growth
  • Slow data collection and analysis
  •  High – automated analysis and ranking
  • Real-time data integration enables faster decisions

 

 

 

 

 

Smart Work Path

Cell Line Development

  1. Transient Expression
    CHO-K1Q cells are transfected with the expression plasmid (pKS001) for initial assessment of protein productivity and growth performance under static and mixing culture conditions.

  2. Selection & Screening
    Post-transfection, cells are cultured in 96-well plates using C.NEST incubators. Clones are evaluated for productivity (titer), viable cell density (VCD), and growth rate. Top candidates are ranked for mini-pool generation.

  3. Stable Mini-Pool Generation
    High-yield clones are expanded under antibiotic-free conditions. Automated titer measurement and culture monitoring ensure optimal pool selection for scale-up.Automated & High-Throughput Workflow
    Screen thousands to millions of clones per round, with significant time and labor savings.

  4. Automated Single-Cell Cloning (C.STATION)
    Selected mini-pools enter C.STATION, Leadgene’s automated CLD platform integrating:
    UP.SIGHT™ for high-precision single-cell dispensing and clonality imaging.
    C.NEST for automated static and suspension culture.
    C.STUDIO for real-time data tracking and compliance reporting.

  5. Screening & Expansion
    Clones progress through 384-, 96-, and 24-well formats to evaluate growth kinetics and productivity. Top producers are shortlisted for scale-up validation.

  6. Scale-Up & Research Cell Banking (RCB)
    High-performing clones are expanded in shake-flasks and bioreactors for process evaluation. Verified lines are cryopreserved as Research Cell Banks, ensuring stability, reproducibility, and readiness for GMP-grade production. 

 

 

Service Tier

Scope / Workflow

Estimated Timeline

Deliverables

Transient Expression

Rapid protein expression using CHO-K1Q fed-batch culture for preliminary titer evaluation.

10–14 days
  • Purified antibody/protein (as requested)

Stable Mini-Pool Generation

Antibiotic-free selection and expansion of high-yield clones through sequential selection, screening, and culture optimization.

4–7 weeks
  • Two cryovials of stable mini-pool (6 × 10⁶ cells/vial × 2)

Single-Cell Clone (RCB)

Monoclonal selection derived from stable mini-pools, including single-cell cloning, screening, and research cell banking.

5–9 weeks
  • Four cryovials of stable single-cell clone (6 × 10⁶ cells/vial × 2)
  • Cell line development report (without stability test)

Single-Cell Clone (RCB)

Stability Study (60 Generations)-Optional

Long-term assessment of cell line consistency in productivity and genetic stability.

7–9 weeks
  • Stability-verified cell line report

Production (Shake Flask)

Small-scale manufacturing performed through seed train preparation and fed-batch process optimization.

3–4 weeks
  • Purified antibody/protein (as requested)

Production (Bioreactor)

Large-scale production using bioreactor seed train and fed-batch process for yield verification.

3–4 weeks
  • Purified antibody/protein (as requested)

 

 

 

With years of experience and a commitment to excellence, Leadgene Biomedical is your trusted partner in cell line development.

Our innovative approach and state-of-the-art facilities ensure that your projects are handled with the utmost care and precision, delivering results that exceed expectations.

 

Contact Us to learn how we can support your cell line development needs and help you achieve your research goals.

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