Your Protein, Our Microbial Expertise
53Biologics offers custom packages to produce your recombinant protein efficiently, from development to clinical stages. We provide robust and reproducible production services adapting to the required quality standard: non-GMP, GMP-like, or full GMP.
If you need GMP…
You are in need of GMP production for your therapeuctic protein (i.e. enzymes, antigens, viral subunits, growth factors, cytokines)
If you need GMP-like/ISO 13485…
Your current needs relies on ancillary reagents like enzymes for diagnostic, enzymes for in vitro transcription,, gene therapy supporting enzymes and other bioprocessing enzymes.
GMP Line 1
Up to 200 L
USP: from 20 L to 200 L stainless steel bioreactors
DSP: centrifuge, HPH, TFF and chromatography
Ideal for preclinical and early clinical phases
GMP Line 2
up to 2000 L
USP: 200 L and 2000 L stainless steel bioreactors
DSP: centrifuge, HPH, TFF and chromatography
Able to handle demands of complex and high-volume productions
Non-GMP Line
up to 500 L
USP: 100 L and 500 L stainless steel bioreactors
DSP: centrifuge, HPH, iltration skids and holders and chromatography
Perfect for early stage or scale-up needs
Alongside drug substance production, we offer integrated drug product manufacturing services, including aseptic fill & finish for clinical and commercial supply. Our capabilities support a seamless transition from bulk drug substance to ready-to-use drug product.
At 53Biologics, we provide dedicated microbial manufacturing lines designed to support recombinant protein projects at every stage, from early non-GMP runs to full GMP supply. We guarantee a reproducible level of quality for all of your productions thanks to our in-house analytical QC capabilities and our skilled QA team.
IP-free Strains
We do not charge royalties or fees for the use of our microbial strains.
Flexible Scales
GMP manufacturing scales of 200 L and 2000 L with DSP equipment associated capable of handling batches from mg to kg.
End-to-end Support
End-to-end DS and DP services with a single partner, minimizing transfer costs to different partners.
Fast Timelines
Thanks to our lean operations and proactive team, project kick-off starts sooner, reducing delays compared to competitors.
Track Record
Experience producing microbial proteins such us biotherapeutic proteins, VLP, enzymes, growth factors and more.
GMP and GMP-like Available
We can perform GMP-like under ISO 13485, and full GMP in accordance with EU GMP.
We know that your project still needs a high degree of quality to ensure process and product consistency even when GMP compliance is not demanded.
Discover more about our CDMO protein 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.