53Biologics is a CDMO that specializes in the clinical manufacturing of biopharmaceuticals
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.
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
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.
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.
FOR MICROBIAL PRODUCTION
Discover more about our CDMO services
Strain & Cell Line Development
Cell Banking
Process Development
Analytical Services
