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Our microbial GMP production facility specializes in high-yield, reproducible manufacturing of therapeutic proteins using E. coli, P. pastoris, and other microbial hosts, adapting from initial preclinical development to full GMP manufacturing.
Our microbial platform is optimized for non-glycosylated recombinant proteins (including antobody fragments and cytokines)
+15
years of microbial experience
2
dedicated GMP manufacturing lines
2000L
maximum fermentation capacity
Quick Turanound
Thanks to our lean operations and proactive team, project kick-off starts sooner, reducing delays compared to competitors.
Experience in Microbial
+10 years of experience with E. coli, Pichia and others microbial hosts with +100 recombinant proteins produced.
Strain Development Support
IP-free molecular biology toolkits for E. coli and P. pastoris to tailor expression systems to your molecule.
Flexible Scales
200L and 2000L ferementers supporting both small and large-scale production, ensuring supply whatever your needs.
Integrated Analytical Services
In-house Quality Control labs with over 90 already qualified analytical methods for proteins.
Aseptic Fill & Finish
In-house aseptic Fill & Finish service that eliminate the need to outsource this task to other companies.
Upstream Capabilities
ISO 7 and ISO 8 cleanrooms equipped with stainless steel 200L and 2000L fermenters. We area capable of scaling up high-density cultures of E. coli and P. pastoris, maintaining batch-to-batch consistency and process robustness under GMP.
Downstream Capabilities
ISO 7/8 cleanroom suites fully equipped with high-pressure homogenizers, single-use tangential flow filtration and single-use chromatography systems. We are experienced in the purification of complex therapeutic proteins.
Fill & Finish Capabilities
Aseptic filling fully compliant with EU GMP Annex I for liquid and solid forms. Available container formats include: vials (2R to 30R), bottles (100 mL to 20L) and single-use bags (250 mL to 200L). Long-term GMP storage available at different temperatures.
CMC Support
We provide CMC support, including scale-up, validation batches and preparation for regulatory submissions. Our goal is to ensure regulatory alignment and clinical readiness at every stage of your protein manufacturing journey.
“What stood out was their ability to adapt quickly to our changing requirements. Their team understood the regulatory context from day one, and delivered high-quality GMP material on time.”
— Senior Director CMC, European Biotech Company
Secure the same reliability for your production needs. Contact us today!
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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