Clonal selection

Clonal selection is a critical process in the development of biologics, involving the isolation and expansion of single cells to establish monoclonal cell lines.

This process ensures genetic consistency and optimal production characteristics, laying the basis for the manufacture of safe and effective biologic therapies.

Clonal selection process

At Clean Cells, we use a meticulous approach to clonal selection, involving:

  • Single-cell isolation: using advanced techniques to isolate individual cells, ensuring documented monoclonality.
  • Clone expansion: growing isolated cells into stable, high-yielding clones suitable for large-scale production.
  • Characterization: assessing clones for productivity, stability, and compliance with regulatory standards.
  • R&D cell bank generation: establishing research and development cell banks from selected clones, providing a reliable source for future manufacturing needs.
  • Cell bank manufacturing: seamless transition to GMP-grade Master and Working Cell Banks, with full traceability and compliance.
Cell banking - track record - 2

Technologies and expertise

Our state-of-the-art facilities are equipped with cutting-edge technologies to support efficient and reliable clonal selection:

  • Automated single-cell dispensers: ensuring precise isolation of individual cells.
  • Greater efficiency of the workflow and screening process: faster evaluation of clones for desirable traits.
  • Advanced imaging systems: verification of monoclonality and assessment of cell outgrowth.

Supported products

Our clonal selection and banking platforms support a wide range of biologic programs, including:

  • Monoclonal antibodies (mAbs)
  • Recombinant proteins
  • Gene-modified cell lines
  • Cell therapy products (CAR-T, NK cells…)
  • Viral vector-producing cell lines (e.g. for AAV, lentivirus)

Comprehensive support services

Beyond clonal selection, Clean Cells offers a suite of services to support your biologic development:

  • Cell banking: creation and storage of Master and Working Cell Banks in GMP-certified facilities

  • Biosafety testing: ensuring cell lines are free from contaminants and meet safety standards.

  • Regulatory compliance: assistance in meeting global regulatory requirements for cell line development.

 

All clonal selection workflows at Clean Cells are developed and validated in accordance with ICH Q5D, ICH Q5B, EMA, and FDA guidance documents. This ensures that from proof of monoclonality to documentation, every step supports future regulatory submissions.

Want to see how clonal selection works?

Watch our short video to discover the key steps, technologies, and regulatory aspects involved in creating a robust, traceable cell line; from single-cell isolation to R&D banking.

Leaflet

Flyer-Sélection-Clonale-17062024-2

Leaflet

Single Cell Cloning Leaflet

Download via media library

For more information, please do not hesitate to contact us.

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