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Microbial Protein Manufacturing
Your protein, our microbial expertise. 53Biologics offers a one-stop-shop solution to produce your recombinant protein efficiently for preclinical, clinical or commercial supply.
Manufacturing turns a validated process into GMP and non-GMP batches across the scale your program needs.
This service is available also for:
Overview
Microbial Manufacturing at Every Stage
53Biologics brings extensive experience in producing a wide range of proteins from therapeutic candidates to enzymes and ancillary reagents. Our facilities are designed to adapt to your protein and its intended use, ensuring seamless transitions from early development to clinical stages and commercial supply. 53Biologics supports the production of a wide range of proteins, from therapeutic proteins and enzymes to ancillary reagents. From low expression and inclusion bodies to downstream bottlenecks, scale-up risk and batch-to-batch consistency, our teams work closely with clients to define a manufacturing strategy that protects product quality, process robustness and supply continuity. With flexible microbial capacity and integrated development, analytical and Drug Subtance and Drug Product manufacturing capabilities, we help programs progress from early batches to clinical and commercial supply without unnecessary transfers or loss of process knowledge.
Capacities for Microbial Protein Production
Line 1 Non-GMP
USP: up to 30L, up to 100 L and up to 500 L stainless steel bioreactors
DSP: centrifuge, HPH, iltration skids and holders and chromatography Perfect for early stage or scale-up needs
GMP Line 2
USP: up to 200 L stainless steel bioreactors
DSP: centrifuge, HPH, TFF and chromatography Ideal for preclinical and early clinical phases
Line 3 GMP
USP: up to 2000 L stainless steel bioreactors
DSP: centrifuge, HPH, TFF and chromatography Able to handle demands of complex and high-volume productions
Process
Our Protein Manufacturing Process
01
Inoculum Preparation
Development and expansion of the production cell bank to ensure a consistent and reproducible manufacturing process.
02
Fermentation
Controlled upstream production using microbial expression systems to generate the target biologic at the required scale.
03
Purification
Recovery, purification and concentration of the product through filtration and chromatography steps to achieve the desired quality attributes.
04
Fill & Finish
Aseptic Filling and lyophilization (when required) and packaging of the final drug product into vials, bottles or single-use bags under GMP conditions.
05
QC & Release
Comprehensive analytical testing and batch review to verify identity, purity, potency, safety and regulatory compliance before release.
Do You Have a Specific Need?
Enzymes & Ancillary Reagents
You need a high-quality microbial protein, not necessary GMP-grade, like enzymes for diagnostic, enzymes for in vitro transcription, gene therapy supporting enzymes or other bioprocessing enzymes.
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Therapeutic Proteins
If you need GMP production for your therapeutic protein (i.e. enzymes, antigens, biosimilars, viral subunits, growth factors, VLPs, cytokines), you can rely on 53Biologics manufacturing service.
Learn MoreTechnical Specifications
Our Key Capabilities for Microbial Proteins
Host Systems
E. coli, P. pastoris and others(i.e Bacillus, Filamentous fungi)
Harvest & Cell Disruption
Disk-stack centrifugation and HPH support robust cell harvest and lysis.
Scalable Fermentation
Stainless-steel bioreactors enable scalable seed-to-production trains for microbial processes.
Integrated DSP
TFF and single-use chromatography are integrated into downstream processing workflows
GMP Manufacturing Suites
Segregated GMP suites for USP and DSP support dedicated microbial manufacturing campaigns.
GMP Storage
Long-term GMP storage from -80 °C to room temperature
Aseptic Fill & Finish
Grade A isolator for aseptic filling in vials, bottles and single-use formats.
Quality System
EMA-inspected QMS operating in accordance with EudraLex Volume 4 and applicable ICH guidelines
Anlaytical Support
90+ validated methods for in-house protein characterization, supporting faster decisions and reliable batch release.
Why Choose 53Biologics for Microbial Protein Manufacturing
Direct Access to the Experts
Work directly with the scientists responsible for your microbial manufacturing program. Close collaboration keeps fermentation, purification, analytical requirements and manufacturing decisions aligned with your protein and development priorities.
Scientific Depth for Complex Proteins
Our teams combine expertise in microbial fermentation, scale-up, downstream purification and analytical control. This integrated knowledge helps address low expression, inclusion bodies, difficult impurity profiles and other molecule-specific manufacturing challenges.
Manufacturing Built Around Your Protein
Host characteristics, process parameters, batch scale and quality requirements shape the manufacturing strategy. Flexible infrastructure allows the process to adapt as data, timelines and production needs evolve.
Continuity from Early Batches to Supply
Keep process development, analytical testing, non-GMP and GMP manufacturing connected with one CDMO. Retaining process knowledge within the same team reduces transfer risk and supports consistent clinical and commercial supply.
Support
Frequently Asked Questions
Common questions about our microbial protein manufacturing services. Can’t find what you need? Talk to our team.
What expression systems do you use for microbial protein production?
We work primarily with well-established microbial platforms such as E. coli and Pichia pastoris, selected based on product characteristics, yield requirements and downstream processing needs. This flexibility lets us optimize each project for speed, scalability and product quality.
What production scales are available for microbial manufacturing?
We offer flexible GMP manufacturing scales from 200 L to 2,000 L, enabling smooth progression from early development to clinical and commercial supply. Our scale-up strategy is designed to minimize risk while maintaining process consistency and robustness.
Do you offer Fill & Finish as well?
Yes. Our Fill & Finish offering includes aseptic filling of liquid sterile formulations and lyophilized (freeze-dried) products under controlled GMP or GMP-like conditions. We support different container formats such as vials and other primary packaging, ensuring flexibility for clinical and specialized biologics.
What types of microbial proteins can you manufacture?
We have experience producing a wide range of recombinant proteins, including enzymes, growth factors, therapeutic proteins, biosimilars and virus-like particles (VLPs). Our platform is designed to handle both simple and highly complex molecules.
Do you offer both Drug Substance (DS) and Drug Product (DP) manufacturing?
Yes. We provide integrated Drug Substance manufacturing, including upstream and downstream processing, as well as Drug Product services through our Fill & Finish capabilities. This end-to-end approach reduces tech-transfer steps, shortens timelines and improves overall process control.
Talk With an Expert About Your Microbial Manufacturing Project
Tell us about your protein, quality grade and target scale — our team will get back to you as soon as possible.
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