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Microbial Therapeutic Proteins
End-to-end microbial protein manufacturing solutions. We help our clients move confidently from preclinical development through clinical trials and commercial production.
Overview
One Manufacturing Partner for the Entire Journey
Developing a therapeutic protein is a long journey. As your product progresses, manufacturing requirements become increasingly complex. Your CDMO should be able to evolve alongside your program.
From process development and analytical characterization to GMP manufacturing and commercial supply, we provide the expertise and infrastructure needed to support every milestone without unnecessary technology transfers or supplier changes.
Our goal is simple: to become your long-term manufacturing partner from first proof of concept through commercialization.
What We Deliver in Each Therapeutic Protein Project
True Partnership Mindset
Different proteins, different timelines, different regulatory requirements and different challenges. From the earliest stages of development, we collaborate closely with your scientists to understand your protein, identify potential risks and design manufacturing processes that support long-term success.
Expertise You Can Rely On
Our scientists have an average of 11.6 years’ experience in recombinant protein expression. We apply this expertise throughout every stage of development to build efficient, scalable and reproducible manufacturing processes.
Built Around Your Program
Development programs rarely follow a straight line. Clinical results evolve. Regulatory expectations change. Manufacturing needs increase. Our flexible approach allows us to adapt quickly without compromising quality or timelines.
Evolving With You
One of the biggest challenges in biologics development is maintaining manufacturing continuity as programs progress. Our manufacturing platform is designed to support your protein throughout its lifecycle. Growing together means fewer tech transfers, reduced risks and greater manufacturing consistency.
Process
Supporting Every Stage of Development
01
Preclinical Development
We support proof-of-concept studies with rapid process development, small-scale manufacturing and analytical expertise that prepares your product for future clinical success.
02
Clinical Manufacturing
We help you establish reproducible manufacturing processes capable of supporting Phase I, II and III clinical studies while maintaining product quality and consistency.
03
Commercial Manufacturing
Our scalable production capabilities allow us to support long-term commercial supply with consistent quality, reliable delivery and manufacturing continuity.
What Sets Us Apart
| Your challenge | Our solution |
|---|---|
| Scaling from preclinical to commercial production | A single manufacturing partner throughout your product lifecycle. |
| Increasing manufacturing demand | Scalable microbial production capabilities. |
| Maintaining product consistency | Robust, reproducible manufacturing processes. |
| Accelerating development | Experienced scientific teams supporting every phase. |
| Reducing operational risk | Long-term manufacturing continuity with fewer technology transfers. |
| Planning for commercial launch | Reliable supply and scalable production capacity. |
Capabilities
Our Manufacturing Model
Our integrated manufacturing model support your program from development through commercialization within a single partnership. The result is a more efficient development pathway with great4er manufacturing continuity and reduce operational risks.
Expression System
E. coli · P. pastoris · other microbial hosts
Quality Standard
Non-GMP · ISO 13485 · GMP
Fill Formats
Vials · bottles · single-use bags
Non-GMP
Up to 500L
Flexible capacity for development and preclinical needs.
GMP
Up to 200L
Consistent manufacturing for small-scale productions.
GMP
Up to 2,000L
Scalable manufacturing capacity suitable for high-volume needs.
Why Partner With 53Biologics
One CDMO Partner. Every Development Phase.
Whether you’re preparing your first preclinical study, advancing into clinical trials, or planning commercial manufacturing, we’re ready to support your next milestone.
Built for Long-Term Success
Our teams work to ensure that the process developed for your first preclinical batch can evolve efficiently toward clinical manufacturing and ultimately commercial production.
Operational Flexibility Built Around You
Processes, timelines and manufacturing strategies that adapt as your program evolves, helping you respond to changing priorities without unnecessary delays.
Scientific Depth Behind Every Batch
Our teams combine expertise in microbial fermentation, downstream purification, scale-up and analytical control to guide critical manufacturing decisions. This scientific depth helps protect process robustness, product quality and GMP readiness.
Talk With an Expert About Your Therapeutic Protein Program
Tell us about your molecule and development stage — our team will get back to you as soon as possible.
Latest News
Latest From Our Blog
Insights, protocols and perspectives from our scientific team.
Support
Frequently Asked Questions
Common questions about our microbial therapeutic protein services. Can’t find what you need? Talk to our team.
Which therapeutic proteins can be manufactured using microbial systems?
Microbial systems are suitable for recombinant proteins in which post-translational modifications are not critical. Typical examples include enzymes, cytokines, growth factors, antibody fragments (Fab, scFv), hormones, virus-like particles (VLPs) and many biosimilar proteins. Our team evaluates each molecule individually to determine whether a microbial host is the most suitable expression system.
Can you support technology transfer from another manufacturer?
Yes. We have experience supporting technology transfer projects and can work closely with your team to ensure a smooth transition while maintaining product quality and manufacturing continuity.
How fast can a therapeutic protein program move to GMP manufacturing?
Fast-track GMP manufacturing in less than 12 months may be possible for mature, well-characterised processes with ready materials and methods. We confirm the timeline after reviewing process maturity, analytical readiness, tech transfer needs and regulatory expectations.
Do you also support analytics, CMC and Fill & Finish?
Yes. 53Biologics combines in-house analytical services, CMC support and EU GMP Annex I aseptic Fill & Finish options. This integrated setup reduces external handoffs and helps sponsors maintain continuity through drug substance, release and drug product preparation.
How do you ensure long-term supply?
We combine scalable manufacturing capabilities, proactive production planning, and collaborative forecasting to help ensure reliable supply as your commercial demand grows.