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cGMP Cell Line Development

The development of cell lines is the starting step of the chemical manufacturing and CMC phases and is the core of the biomanufacturing process. High yield and quality cell lines provide a solid foundation for a successful biopharmaceutical production process and determine the quality of the final product. Creative Biogene is committed to providing efficient cell line development services based on our extensive experience in cell line development and leveraging our advanced cGMP technology platform. We specialize in providing all services from vector construction to screening of stable and highly expressed cell lines. These cell lines are GMP compliant and can effectively help our customers to successfully develop and produce biologics such as biosimilars, enzymes, cytokines, antibodies, vaccines and other recombinant proteins.

What We Do

Creative Biogene has advanced technology platforms and strong development capabilities to provide GMP development services for a wide range of cell lines for different bioprocess applications, including but not limited to the following:

  • Biosimilar Cell Line Development
  • Bioproduction Stable Cell Line Development
  • High-Performance CHO Stable Cell Line Development
  • CAR-T Cell Development Services
  • TCR-T Cell Development Services
  • CAR-NK Cell Development Services

Our Services

We provide comprehensive one-stop solutions for cGMP cell line development from research-grade cell line development, PCB/MCB/WCB/EOPC banking and characterization, upstream/downstream process (USP/DSP) development, all the way up to small/pilot/large-scale production. We could work with multiple host systems including mammalian cells, yeasts, and bacteria.

Vector Design and Construction

Vector Design & Construction

  • Selecting The Right Vector
  • Codon Optimization
  • Gene Synthesis
  • Plasmid Construction
  • Target Sequence Sequencing
Cell Line Screening and Characterization

Cell Line Screening and Characterization

  • Host Cell Evaluation
  • Cell Line Engineering
  • Stable Pool Selection
  • Clone Isolation & Screening
  • Cell Bank Establishment & Characterization
  • Stability Testing
Cell Line Manufacturing Process Development

Cell Line Manufacturing Process Development

  • Cultivation & Yield Optimization (USP)
  • Purification Optimization (DSP)
Upscaling and Production

Upscaling & Production

  • Small-Scale Production
  • Pilot-Scale Production
  • Large-Scale Production

Cell Line Development Process at Creative Biogene

Creative Biogene's experienced scientific team provides a standardized process for cell line development, with the entire development cycle typically taking 12-18 months. We can meet the individual demands of our clients at any stage of cell line development, thus ensuring successful research cell banks (RCB), master cell banks (MCB) and working cell banks (WCB). Once the cell line development process is complete, we generate high-quality cell libraries that can be used for further process development and optimization, as well as high level production, thus helping our clients save time and obtain high-quality custom cell lines.

Cell Line Development Process at Creative Biogene

What We Deliver

Starting MaterialDeliverablesTurnaround Time
Gene sequence or plasmidHigh expression cell pool (1-5 cells)6-7 weeks
Gene sequence or plasmidMonoclonal cell lines (3-6 strains)7-8 weeks
Gene sequence or plasmidMaster cell bank4 weeks
Gene sequence or plasmidWorking cell bank4 weeks
Gene sequence or plasmidCell bank stability analysis (60-90 generations)10-13 weeks
Gene sequence or plasmidPurified protein4-10 weeks
Gene sequence or plasmidPurified antibodies4-10 weeks

Why Choose Us

  • Over 10 years of expertise in cell line development ensures highly productive cell lines suitable for commercially relevant processes.
  • Full package service capability, offering complete expression systems, powerful gene editing capabilities, and high-productivity stable pool/clone.
  • Our cell line development services are flexible and customizable, offering the advantages of high success rates and batch-to-batch consistency.

Creative Biogene, as a trusted provider of GMP cell line development services, we are committed to providing cost-effective, high-quality and efficient outsourcing solutions to meet any of our clients' demands and priorities in the biologics and drug development pipeline. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.

* For research use only. Not intended for any clinical use.
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