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.
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 for therapeutics, and/or commercial-scale production for enzymes and ancillary reagents. With deep expertise across upstream and downstream processes, we deliver robust, scalable, and high-quality manufacturing tailored to your protein.
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.
Different Scales for Different Needs
We have state-of-the-art facilities and equipment that enable us to provide reliable and efficient services to our clients. Our facility operates ISO Class 7 clean rooms, ISO Class 8 clean rooms and analytical laboratories to support product testing.
Stainless steel equipment
To streamline the path from bulk drug substance to clinical supply, we also offer aseptic Fill & Finish services in vials, bags, and bottles under GMP conditions. Our ISO 5 isolator technology makes 53Biologics a reliable partner for end-to-end microbial protein manufacturing.
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.
To meet high quality standards, our non-GMP manufacturing service is integrated with our analytical service, guaranteeing a customized package for characterization and stability testing. Our quality control department follows up all our non-GMP processes to ensure that your recombinant proteins (enzymes, reagents, virus like particles…) are produced to the highest standards.
We cover the entire development cycle of your recombinant protein from early-stage to commercial manufacturing
100L – 500L
Stainless steel equipment
Discover more about our CDMO protein services
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