Cell Line Development
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. We are well placed to provide rapid development of well characterized mammalian cell lines with a good clinical record. We offer more than 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.
Key features
- CHO K1, CHO-GS and CHO-S systems available
- Up to 8g/L
- FDA/EMA standards, TSE/BSE testing with fully traceable documentation
- Royalty free platforms
- Flexible commercial licensing
- Robust and scalable system
- Proven stability over 120 generation cycles
- Early stage manufacturability assessment
- Flexible tech-transfer to the CMO of your choice
Stable Pools and Research Cell Lines
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 can 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 GMP-ready Research Cell Bank (RCB).
Manufacturing Cell Lines
Using both standard and fast-tracked protocols we can deliver a monoclonal RCB in approximately 4 months. We deliver a robust manufacturing cell line; high throughput screening of clones, detailed characterization in batch cultures, provision of multiple cell banks and flexible tech transfer to the CMO of your choice. Extended stability studies give you confidence ahead of your GMP manufacturing campaign and robust documentation ensures regulatory compliance.
We have long-standing relationships with large-scale GMP manufacturing partners and regulatory advisers to facilitate seamless transfer to the clinic.
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