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CDMO Services for Mammalian Proteins
Integrated support for mammalian biologics, from cell line development to GMP manufacturing. One coordinated partner, combining scientific expertise, flexibility and continuity as your program advances.
Our Expertise in Mammalian Hosts
CHO
The industry gold standard for monoclonal antibodies and recombinant proteins. Variants from our partners are available for:
Afucosylated antibodies
High-yield stable expression
HEK
Excellent for transient expression and complex proteins. Our partners have variants available for:
Authentic human post-translational modifications (glycosylation)
T-antigen-free variants
Others
Access to cutting-edge lines from our partners designed for challenging proteins. For example:
Authentic human-like glycosylation patterns
2000 L
GMP capacity (up to)
~11.6
Years of average team experience
150
Recombinant proteins released
3
Weeks to project start after signature
Overview
When Does Your Protein Require Mammalian Expression?
Some biologics depend on complex folding, human-like glycosylation or other post-translational modifications to achieve their intended biological activity. In these cases, mammalian cell expression often becomes the preferred manufacturing strategy despite its higher complexity.
Our scientists work with you to assess your molecule’s critical quality attributes, functional requirements and development objectives, helping determine when mammalian expression provides the best balance between product quality, regulatory expectations and manufacturing feasibility.
The complete mammalian pipeline — select any stage to explore that service in detail.
Explore Our Mammalian Services
Cell Line Development
Develop a production-ready mammalian cell line in CHO, HEK or another suitable expression platform with our specialized partners. We define the optimal host and strategy based on your protein and future manufacturing needs.
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Cell Banking
Establish a reliable, well-characterized cell bank to support development and manufacturing. We coordinate the generation, testing and documentation of Research, Master and Working Cell Banks, aligned with your downstream process strategy.
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Process Development
Optimize mammalian upstream and downstream operations to balance yield, cost, robustness, operability and scalability — with single-use bioreactors, chromatography, TFF and viral-inactivation strategies ready for scale-up and GMP transfer.
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Analytical Services
Integrated analytical services across raw-material testing, in-process control, release and stability studies. More than 90 already-validated methods reduce outsourcing and keep analytical data connected to manufacturing decisions.
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Protein Manufacturing
Produce mammalian cell-derived APIs in our single-use GMP facilities. We support GMP production up to 2000 L and non-GMP work up to 50 L for antibodies, biosimilars, fusion proteins and other mammalian proteins.
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Fill & Finish
Complete your program with aseptic Fill & Finish. We support Drug Product manufacturing in vials, bottles and single-use bags, with batch-release documentation for preclinical, clinical and selected commercial needs.
Learn MoreTypical Recombinant Proteins Produced Using Mammalian Cells
| Molecule Type | Typical Examples |
|---|---|
| Monoclonal Antibodies | Full-length IgG molecules |
| Fusion Proteins | Fc-fusion proteins |
| Complex Glycoproteins | EPO, clotting factors |
| Recombinant Hormones | FSH, LH, TSH |
| Viral Antigens | Vaccine proteins |
| Difficult-to-express Proteins | Secreted or highly glycosylated proteins |
Every biologic is unique. Our scientific team works with you to evaluate the most suitable expression platform based on your protein, development objectives and manufacturing requirements.
Why Protein Production Is Different When You Do It With 53Biologics
We Don't Step Back. We Step Up.
With fully integrated in-house capabilities and direct scientist-to-client engagement, we remove the barriers that typically sit between your program and its progress.
We Earn Trust by Delivering, Not Promising
53Biologics brings the science and accountability needed when the stakes are high. You can progress with confidence, knowing quality is protected and continuity is maintained from one stage to the next.
Built Around Your Program
With experience across diverse biologics platforms and integrated capabilities that can be tailored at each stage, we give clients the flexibility to find the best fit at every step.
We Succeed When You Do
You need a partner who treats your success as their own, not just a set of tasks to complete. 53Biologics shares ownership of the outcome and stays engaged from the first decision to final delivery.
Request a Quote for Your Mammalian Protein Program
Tell us about your molecule and manufacturing goals — our scientific team will get back to you as soon as possible.
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