Each protein behaves differently, which is why every project is different and unique to us
Delays, rigid processes and scalability uncertainties can slow down your enzymes or therapeutic protein project. At 53Biologics, we remove those barriers. Whether you need rapid R&D material, a scalable path toward clinical phases or commercial supply we work as an extension of your team reducing technical risk while accelerating your path to reliable production.
At 53Biologics we are experts in recombinant protein manufacturing. Our multidisciplinary team combines the experience in Molecular Biology, Microbiology, Fermentation and Protein Purification to driveefficient production processes.
With a wide range of manufacturing capacities under both GMP and non-GMP conditions, we can adapt scale and quality standars to your needs from early development to commercial manufacturing.
Fast timelines, high yields and robust scalability are critical in microbial protein production and that’s exactly where we add value.
Strain Development
Vast experience with E. coli and Pichia pastoris but also many other microbial strains like Bacillus, Saccharomyces and fungal expression systems.
Cell Banking
Fully capable to produce and characterize Master Cell Banks (MCB) and Working Cell Banks (WCB) in our GMP compliant suits.
Process Development and Scale-up
Our team combines deep expertise in fermentation and purification to tackle common challenges such as low expression, inclusion bodies, and downstream bottlenecks.
GMP Manufacturing
From preclinical to commercial supply, our GMP microbial manufacturing service delivers high quality proteins you can trust.
Fill & Finish
Aseptic Fill & Finish services supporting your product from preclinical batches through to commercial supply.
When product quality, consistency and regulatory readiness are non-negotiable, 53Biologics can deliver a highly controlled and experienced approach working with mammalian systems.
Cell Line Development
We collaborate with recognized partners to develop mammalian cell lines based in CHO and HEK293.
Cell Banking
Develoment and characterization of Master Cell Banks (MCB) and Working Cell Banks (WCB) in our GMP compliant suites.
Process Development
We design and optimize mammalian processes on CHO and HEK293 platforms so you can achieve the right balance of yield, cost, robustness, operability and scalability.
GMP Manufacturing
You can rely on 53Biologics for GMP manufacturing of mammalian cell-derived APIs, like antibodies, mAbs, biosimilars or growth factors.
Fill & Finish
Aseptic Fill & Finish services supporting your product from preclinical batches through to commercial supply.
Our track record includes monoclonal antibodies, fusion or nanobodies, antigens, viral proteins, virus like particles, cytokines and growth factors to be used in vaccines or as therapies and a broad range of enzymes for diagnostic and ancillary reagent application.
One-Stop-Shop Solution
We can support you at every stage, from early R&D to commercial supply, from CLD to F&F.
Flexible and Adaptability
Different scales (200 L & 2000 L), expertise (microbial & mammalian) systems and quiality standars (ISO & GMP)
Microbial and Mammalian Capacity
Well suited for microbial and mammalian production ensuring robust results.
Cost-competitive
Our operations structure and location make our services cost-competitive in relation with other CDMOs.
Discover more about 53Biologics Services for Proteins
If your protein is produced by a microbial host:
If your protein is produced by a mammalian host:
We would love to hear from you!
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