Each protein behaves differently, which is why every project is unique to us.
Delays, rigid processes and scalability uncertainties can slow down your enzymes or API 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.
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
Vast experience with E. coli and Pichia pastoris but also many other microbial strains like Bacillus, Saccharomyces and fungal expression systems.
Process Development
Vast experience with E. coli and Pichia pastoris but also many other microbial strains like Bacillus, Saccharomyces and fungal expression systems.
GMP Manufacturing
Vast experience with E. coli and Pichia pastoris but also many other microbial strains like Bacillus, Saccharomyces and fungal expression systems.
Fill & Finish
Vast experience with E. coli and Pichia pastoris but also many other microbial strains like Bacillus, Saccharomyces and fungal expression systems.
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 Scales
Manufacturing scales of 200 L and 2000 L in both microbial and mammalian systems.
Microbial and Mammalian Capacity
Well suited for microbial and mammalian production ensuring robust results.
Fast Track Supply
From gene to Drug Substance in just 12 months for expedited project timelines.
Different Quality Grades
Research grade under ISO 9001, GMP-like under ISO 13485, and full GMP compliance.
Customized Solutions
We offer customized services to meet your specific requirements, as each project is unique.
We Care About You
We work closely with you to ensure your success, because when you succeed, we succeed.
Biologics At The Core
As a CDMO specialized in biologics, protein manufacturing is part of our expertise in bioprocesses.
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!
Please note that job applications submitted through this form will not be considered. Use the Careers page.
