Protein Manufacturing Services

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53Biologics is a CDMO that specializes in the clinical manufacturing of biopharmaceuticals

Protein Manufacturing for Biotherapeutics

From a prompt and punctual batch to a commercial manufacturing campaign, we are ready to start production.

Our facilities include pilot-scale fermenters, but also single-use bioreactors and equipment for clinical manufacturing that allow us to produce batches of up to hundreds of grams. We have experience in recombinant protein manufacturing using microbial strains and mammalian cell lines.

High quality services for non-GMP needs

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 (antibodies, enzymes, reagents, virus like particles…) are produced to the highest standards.

We cover the entire development cycle of your biotherapeutics, from  early-stage to manufacturing


GMP Manufacturing Services

We are the perfect partner for the production of your biotherapeutics or recombinants proteins like monoclonal antibodies, biosimilars, enzymes or virus like particles for preclinical and clinical trials and commercial supplies thanks to our state-of-the-art GMP manufacturing facilities.

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.

60L - 2,000L


Interested in Bulk Production? Contact Us!

    Discover more about our CDMO services

    Strain & Cell Line Development

    We have wide experience in E.coli, P. pastoris and fungal strain development and mammalian cell line development for the manufacturing of your biologic.
    cell banking

    Cell Banking

    We are fully capable to produce and characterize Master Cell Banks (MCB) and Working Cell Banks (WCB) in our GMP compliant suits.

    Process Development

    Our experts in Upstream and Downstream Development provide personalized attention and ensure the most effective and innovative solutions for complex challenges.

    Analytical Services

    From early development to commercial manufacturing, we provide multiple analytical testing services to support your protein project.