53Biologics is a CDMO that specializes in the clinical manufacturing of biopharmaceuticals from preclinical to clinical phases
Our state-of-the-art facilities boast a diverse array of fermenters, ranging from small-scale lab setups to pilot and final manufacturing scale bioreactors. These bioreactors come in various configurations, including glass, stainless steel, and single-use options. In addition, they are complemented by downstream equipment of varying scales, from reusable to single-use, our facilities enable the production of batches ranging from small milligrams to hundreds of grams. This adaptability allows us to cater to diverse applications and also under different quality requirements.
At 53Biologics, we've made significant investments in our manufacturing capabilities to offer expedited timelines for batch production. Our manufacturing team is proficient in transference activities, engineering runs, and validation batches, ensuring swift project initiation. Moreover, our analytical team is equipped with a comprehensive suite of QC methods that can be readily tailored to meet project specifications. Leveraging a robust network of audited partners, we're primed to meet the demands of your projects with agility and efficiency.
With ISO9001:2015, ISO13485:2016, and cGMP certifications underpinning our manufacturing procedures, we prioritize adaptability to meet your specific needs. Whether it's delivering prompt R&D or preclinical batches, executing initial cGMP validation batches, or orchestrating full-scale clinical manufacturing campaigns, our processes are tailored to ensure compliance and quality at every stage. Furthermore, our commitment to environmental responsibility is underscored by our ISO14001:2015 certification, affirming our dedication to enhancing the environmental performance of recombinant protein manufacturing processes.
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.
Reusable and Single Use equipment
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
500L
Reusable fermenters
50L
Single Use bioreactors
Discover more about our CDMO protein services
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