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

With expertise in a range of mammalian cell lines we offer confidence and flexibility while supporting your clinical development. Whether for research or GMP purposes, come to us for rapid development of well characterized mammalian cell lines with a good clinical record. We offer more than Stable Cell Line Development; our mAb design technologies can be employed in parallel to dramatically improve yield and manufacturability. We have long-standing relationships with large-scale manufacturing partners and regulatory advisers to facilitate seamless transfer to the clinic.

Cell line Development

We offer a variety of cell line development options to suit your needs; stable mini-pools for early evaluation, Research Cell Banks (RCB); and Master Cell Banks (MCB, through our partners).

Stable Pools and Research Cell Lines

A range of flexible, adaptable development options are available to provide a customized pathway to the clinic.

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 Cell Lines

Through our GMP partners, Master Cell Bank (MCB) generation can be tailored to your 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

  • FDA/EMA standards with fully traceable documentation on the generation of the cell line including a final report and TSE/BSE documentation
  • CHO K1, CHO DG44 and HEK293 systems available
  • Royalty free platforms
  • Typical titres between 2g/land 8g/L(with an inverse reduction of downstream cost with increase in titer)
  • Robust and scalable system from 1 to 1,000 litre bioreactors
  • 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
Stable cell lines

Why Fusion Antibodies?

Our depth of technical knowledge, experience and supporting services are key to a successful clinical outcome.

  • 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
  • Reduced cost, reduced timelines , increased flexibility and unrivalled customer service

Contact us today