One-stop-shop solution for microbial protein production: from strain development to Fill & Finish
At 53Biologics, we provide end-to-end solutions for microbial protein production, with experience in Escherichia coli, Pichia pastoris and filamentous fungi such as Trichoderma and Aspergillus or the revolutionary C1. Whether you require complex biotherapeutic proteins or simple enzymes, we ensure reliable delivery at every stage of the journey.
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
Deep expertise in fermentation and purification to tackle common challenges such as low expression or inclusion bodies.
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.
If you need GMP…
You are in need of GMP production for your therapeuctic protein (i.e. enzymes, antigens, viral subunits, growth factors, cytokines)
If you need GMP-like/ISO 13485…
Your current needs relies on ancillary reagents like enzymes for diagnostic, enzymes for in vitro transcription,, gene therapy supporting enzymes and other bioprocessing enzymes.
Microbial expression systems remain a cornerstone for recombinant protein production due to their speed, robustness, and cost-effectiveness. At 53Biologics, we combine these advantages with state-of-the-art GMP facilities and proven expertise to accelerate your program.
Rapid Timelines
From gene to protein in a few months
Cost-effective
Ideal for enzymes and non-glycosilated proteins
Diversity of Hosts
E. coli, P. pastoris, and filamentous fungi (Trichoderma, Aspergillus, C1)
Scalable Solutions
non-GMP and GMP suites up to 2000 L
Regulatory Support
EMA-inspected, ICH, 21CFR, and Eudralex vol. 4 compliant.
Experience with Multiple Hosts
From E. coli and P. pastoris to filamentous fungi (Trichoderma, Aspergillus, C1), offering the most suitable host for each project.
End-to-end Solution
Integrated services for microbial protein production from strain development to GMP manufacturing and Fill & Finish.
Track Record
+15 GMP microbial batches released annually, 25+ audits successfully passed, and EMA-inspected facilities.
No Queue Time
Thanks to our lean operations and proactive team, project kick-off starts sooner, reducing delays compared to competitors.
Aseptic Fill & Finish
In-house aseptic Fill & Finish service that eliminate the need to outsource this task to other companies.
Regulatory Confidence
QMS compliant with EMA, ICH, 21CFR, and Eudralex vol.4 standards, ensuring smooth regulatory submissions.
Discover more about 53Biologics Microbial 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.
Copyright © 2024 53Biologics. All Rights Reserved
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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.
Copyright © 2025 53Biologics. All Rights Reserved
Site Navigation
Policies