Flexibility to support mammalian cell line development across diverse host systems
At 53Biologics, we collaborate with trusted partners to offer cell line development and banking services for a wide variety of mammalian hosts. Our flexible approach ensures that each client can work with the most suitable system for their specific protein, whether a well-established line such as CHO or HEK293, or more innovative cell platforms designed for challenging biologics.
From clone selection to commercial readiness, our integrated approach standardizes every step so you start development and manufacturing on a reliable, compliant starting point. The payoff: fewer surprises in scale-up and faster progress to critical milestones.
CHO
Industry gold standard for monoclonal antibodies and recombinant proteins.
Robust performance, scalability, and high yields (>8 g/L with advanced lines like CHOExpress®).
Variants available for afucosylated antibodies (CHO Flow®) or high-yield stable expression (CHOnamite®).
HEK293
Excellent for transient expression and complex proteins. Suitable for authentic human post-translational modifications (glycosylation). Advanced systems such as HEKExpress® (up to 9 g/L and more than 4 months stability) and HEK2Express® (T-antigen free, large-scale production).
Other Platforms
Custom solutions available depending on client requirements. Access to cutting-edge lines designed for challenging proteins. GlycoExpress® (GEX®) ensures authentic human-like glycosylation patterns, offering clear advantages for therapeutic proteins where precise glycoforms are critical.
Research Cell Bank Generation
release under ISO 9001
Master Cell Bank Generation
GMP-compliant and release following ICH guidelines
Working Cell Bank Generation
GMP-compliant and release following ICH guidelines
Full Characterization Services
GMP-compliant following ICH guidelines for MCB/WCB
Long-term Storage
Possibility of long-term storage of your cell banks
We provide a comprehensive catalogue of analytical services to ensure the identity, purity, viability, and stability of mammalian cell banks, applying molecular, genetic, and microbiological assays such as:
53Biologics ensures your mammalian projects are developed under the highest international quality standards
EMA
EMA-inspected manufacturing facilities
QMS
21 CFR & Eudralex vol.4 compliant
+90
already validated analytical methods
One-Stop-Shop Solution
RCB, MCB, WCB generation, full characterization, release, and long-term storage services, all aligned with GMP.
ICH-oriented Framework
Programs run to the intent of ICH Q5D/Q5A(R2)/Q6B with phase-appropriate testing strategies and documentation.
Diversity of Mammalian Platforms
Full acces to cutting-edge mammalian platforms, with true adaptability to your preferred host and project more.
Discover more about 53Biologics CDMO services
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53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins. The company provide services from preclinical development to GMP manufacturing, supporting their clients in getting their biological products to market as quickly as possible.
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