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Our microbial cGMP production facility specializes in high-yield, reproducible manufacturing of therapeutic proteins using E. coli, P. pastoris, and other microbial hosts, adapting from intial preclinical development to full cGMP manufacturing.
At 53Biologics, we specialize in the development and GMP manufacturing of therapeutic proteins using microbial expression systems such as E. coli and P. pastoris. Our microbial platform is optimized for non-glycosylated biologics — including enzymes, antibody fragments, and cytokines — offering a fast, scalable, and cost-effective path from gene to drug product.
With over 15 years of experience and in-house fermentation capabilities up to 2000L, we provide end-to-end solutions tailored to your molecule’s complexity and development stage. From strain development to cGMP fill & finish, our team ensures technical robustness, regulatory compliance, and speed — with no queue times and full project ownership.
Fast Timelines, Flexible Batches
No queue times and full adaptability from milligrams to kilograms, non-GMP to GMP.
Microbial Expertise
Over 15 years of experience developing and manufacturing therapeutic proteins in E. coli and P. pastoris.
Strain Engineering Support
IP-free molecular biology toolkits to tailor expression systems to your molecule.
High-Yield Fermentation
Robust microbial processes with 200L and 2000L fermenters for small to large-scale GMP production.
Integrated Development & Analytics
Seamless USP/DSP development with in-house QC labs and over 90 qualified analytical methods
GMP Fill & Finish On-Site
Avoid costly tech transfers with in-house & partnered clinical fill & finish capabilities Annex I-compliant.
Our ISO 7 and ISO 8 cleanrooms are equipped with stainless steel and single-use fermenters at 200L and 2000L scales, enabling phase-appropriate microbial GMP manufacturing for therapeutic proteins.
We specialize in scaling up high-density cultures of E. coli and P. pastoris, maintaining batch-to-batch consistency and process robustness under GMP.
Fermentation parameters are tightly controlled and monitored in real-time, ensuring optimal expression, cell viability, and product quality.
Our downstream operations support clinical-grade purification with high-performance platforms, including high-pressure homogenizers, single-use tangential flow filtration, and single-use chromatography systems.
Our ISO 7/8 cleanroom suites are fully equipped for batch record–controlled DSP activities, aligned with EMA or FDA expectations. We are experienced in the purification of complex therapeutic proteins such as enzymes, cytokines, and antibody fragments.
We provide aseptic filling in Grade A isolators, fully compliant with Annex I. Available container formats include:
Ideal for clinical trial material and orphan drug supply, with QA-controlled operations, validated equipment, and GMP-compliant storage from –80°C to room temperature.
Our multidisciplinary team provides CMC-aligned process 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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