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—bank design, controlled expansion, aseptic filling, full characterization, and qualified long-term storage—so you start development and manufacturing on a reliable, compliant substrate. The payoff: fewer surprises in scale-up, smoother tech transfer, and faster progress to critical milestones.
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®)
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)
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.
We support clients through all stages of mammalian cell banking, ensuring quality and regulatory compliance:
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:
RCB, MCB, WCB generation, GMP-aligned manufacturing, full characterization, release, and stability/storage services.
Programs run to the intent of ICH Q5D/Q5A(R2)/Q6B with phase-appropriate testing strategies and documentation
Documentation packages designed to support multinational clinical submissions and smooth regulatory interactions.
Full acces to cutting.edge mammalian platforms, with true adaptability to your preferred host and project needs.
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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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