Microbial Protein Development & Manufacturing Services

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From strain engineering to GMP-compliant protein production.

At 53Biologics, we provide end-to-end solutions for microbial protein production, leveraging our extensive expertise in Escherichia coli, Pichia pastoris, and filamentous fungi such as Trichoderma and Aspergillus or the revolutionary C1. Our flexible and scalable platforms support projects from early development to large-scale GMP manufacturing, offering rapid timelines, cost-effective processes, and robust quality standards. Whether your program requires enzyme production or complex biotherapeutic proteins, we ensure reliable delivery at every stage of development.

Cont(r)act our microbial experts

Why Choose a Microbial Host for Protein Production?

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 few weeks/months

Cost-efective

Ideal for enzymes and non-glycosilated proteins

Versatile Hosts

expertise in E. coli, P. pastoris, and filamentous fungi (Trichoderma, Aspergillus, C1)

Scalable Solutions

non-GMP and GMP suites up to 2000 L

Regulatory Compliance

EMA-inspected, ICH, 21CFR, and Eudralex vol. 4 compliant.

Applications of Microbial Systems:

Enzymes & Other Ancillary Reagents

Enzymes for Diagnostic, industrial, IVT, gene therapy supporting enzymes and other bioprocessing enzymes.

Therapeutics Proteins

Antigens, viral subunits, growth factors, cytokines, etc

Why 53Biologics as Your Microbial CDMO

Flexible platforms

From E. coli and P. pastoris to filamentous fungi (Trichoderma, Aspergillus, C1), offering the most suitable host for each project.

End-to-end in One Partner

Integrated services from strain development and cell banking to GMP manufacturing and Fill & Finish, avoiding technology transfers.

Extensive Track Record

+15 GMP microbial batches released annually, 25+ audits successfully passed, and EMA-inspected facilities.

Regulatory confidence

QMS compliant with EMA, ICH, 21CFR, and Eudralex vol.4 standards, ensuring smooth regulatory submissions.

No Queue Time

Lean operations allow project kick-off usually within 2–3 weeks after contract signature, minimizing delays vs. competitors.

Facilities and Capabilities

Our microbial manufacturing suites are designed to deliver safe, compliant and efficient recombinant protein production, from development to GMP. Segregated areas and validated workflows minimise cross‑contamination risk.

Segregated GMP suites for USP, MSP and DSP dedicated to microbial campaigns.
Stainless‑steel bioreactors with scalable seed‑to‑production trains.
Disk‑stack centrifugation and high‑pressure homogenization for robust cell harvest and lysis.
TFF and single‑use chromatography integrated in downstream processing.
Grade A isolator for aseptic Fill & Finish in vials, bags and bottles (Annex I aligned).
Long‑term GMP storage (‑80 °C to RT) with continuous monitoring and backup power.
EMA‑inspected QMS (ICH / 21 CFR / Eudralex) supporting audits and regulatory submissions.

Discover more about 53Biologics Microbial Services

Strain Development

Cell Banking

Process Development

Analytical Development

Protein Manufacturing

Fill and Finish

Interested In Our Microbial Services?

We would love to hear from you!

Please note that job applications submitted through this form will not be considered. Use the Careers page.

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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