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Supply & Characterization04 / 07
Specialist serviceCell Line Development
At Fusion Antibodies, we bring extensive experience with a variety of mammalian expression systems to support your clinical development with confidence and flexibility. We specialize in the rapid generation of well-characterized, regulatory-compliant cell lines with strong clinical track records.
30+ years of antibody expertise250+ humanization projectsOne integrated scientific team
Published from Fusion CMS
Cell Line Development
At Fusion Antibodies, we bring extensive experience with a variety of mammalian expression systems to support your clinical development with confidence and flexibility. We specialize in the rapid generation of well-characterized, regulatory-compliant cell lines with strong clinical track records.
Key Capabilities
- Expertise in CHO-K1, CHO-GS knockout, CHO-S, and HEK293 platforms
- Proven success with IgG, bispecific/multispecific antibodies, fusion proteins, and nanobodies
- High-yield production: up to 8 g/L (average ~3 g/L for IgG)
- Compliance with FDA/EMA standards, including TSE/BSE testing and full traceability
- Demonstrated stability over 120+ generations
- Early-stage manufacturability assessments
- Seamless tech transfer to your preferred CMO
Stable Pools & Research Cell Lines
Our flexible development pathways are ideal for preclinical applications such as in vivo efficacy, PK/PD, or protein characterization studies. Expression from stable pools enables scalable protein production (1 mg to 1 g) without the need for full cell line development.
For added flexibility, we can develop multiple cell lines in parallel to the minipool stage. Early expression and stability data guide the selection of the optimal system before advancing to a GMP-ready Research Cell Bank (RCB).
Manufacturing Cell Lines
We deliver monoclonal RCBs in approximately four months using standard or accelerated workflows. Our offering includes:
- High-throughput clone screening
- Batch culture characterization
- Multiple cell bank generation
- Extended stability studies
- Regulatory-compliant documentation
- Flexible tech transfer to your chosen CMO
We maintain strong partnerships with GMP manufacturing providers and regulatory consultants to ensure a smooth transition from development to clinical manufacturing.
For more information about cell line development
A connected workflow
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Questions, answered
Can this capability connect to another Fusion service? ＋
Yes. Our teams are designed to share context across discovery, engineering and supply.
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