Cell Line Development

Cell Line Development

Cell Line Development

We deliver robust, high yield, stable cell lines to underpin your GMP manufacturing campaign

Cell Line Development

Fusion Antibodies has experience with a range of mammalian cell lines to offer confidence and flexibility supporting your clinical development. For both research and GMP purposes we are well placed to provide rapid development of well characterized mammalian cell lines with a good clinical record. We offer more than stable Cell Line Development (CLD); our upstream protein engineering technologies can be employed in parallel to dramatically improve yield and manufacturability.

Begin with the end in mind. Flexible, adaptable development options are available to provide a customized pathway to the clinic.

Cell line Development

Stable Pools and Research Cell Lines

For smaller projects such as preclinical in vivo efficacy studies, PK/PD studies or protein characterization studies; expression from stable pools is the perfect solution for supply of purified protein in the order of 1mg to 1g.
For maximum flexibility, we also offer the option to develop multiple cell lines in parallel to the minipool stage. Initial expression and stability data can then be used to select a lead candidate to progress to a stable, GMP-ready Research Cell Bank (RCB).

Manufacturing Cells

We have long-standing relationships with large-scale manufacturing partners and regulatory advisers to facilitate seamless transfer to the clinic.

Through our GMP partners, Master Cell Bank (MCB) generation can be tailored to your GMP production needs. High throughput screening of clones, extended stability studies, detailed characterization in batch cultures, provision of multiple cell banks and flexible tech transfer delivers a robust manufacturing cell line for GMP material.

Key features

  • CHO K1, CHO-GS, CHO DG44 and HEK293 systems available
  • FDA/EMA standards with fully traceable documentation on the generation of the cell line including a final report and TSE/BSE documentation
  • Royalty free platforms
  • Flexible commercial licensing
  • Typical titres between 2g/land 8g/L(with an inverse reduction of downstream cost with increase in titer)
  • Robust and scalable system
  • Proven stability over 120 generation cycles
  • Early stage manufacturability assessment
  • Continual monitoring of product quality
  • Flexible tech-transfer from our GLP manufacturing site to our cGMP partner facilities or your preferred CMO

Why Fusion Antibodies?

  • Reduced cost, reduced timelines, increased flexibility and unrivalled customer service
  • Open and flexible approach to business and project planning
  • Proven, reliable biologics manufacturing services (antibodies and non-antibody proteins)
  • Regulatory support
  • State-of-the-art facilities with complete project isolation
  • Suite of supporting services including early stage developability assessment, protein engineering, affinity maturation and humanization

Contact us today