Outsource your biologics manufacturing to 53Biologics
We are the perfect partner for the production of your biotherapeutics or recombinants proteins like monoclonal antibodies, biosimilars, growth factors, etc for preclinical and clinical trials and commercial supplies thanks to our state-of-the-art GMP manufacturing facilities.
Our mammalian GMP manufacturing line integrates upstream, midstream, and downstream processes with associated utilities and auxiliary equipment, enabling seamless transfer from development to clinical and commercial supply.
Associated single use downstream equipment including auxiliary tanks, centrifuges, tangential flow filtration single use and chromatography 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.
Our quality control department follows up all our non-GMP processes to ensure that your recombinant proteins (monoclonal antibodies, biosimilars, …) are produced to the highest standards.
We cover the entire development cycle of your biotherapeutics, from early-stage to manufacturing
20L – 50L
Single Use bioreactors and associated Single Use downstream
Our state-of-the-art facilities boast a diverse array of bioreactors, ranging from small-scale lab setups to 200L bioreactor. In addition, they are complemented by single-use downstream equipment of varying scales. That is whay our facilities enable the production of batches ranging from small milligrams to hundreds of grams. This adaptability allows us to cater to diverse applications, also under different quality requirements.
More than 15 GMP batches per year for the production of monoclonal antibodies, biosimilars, Fc-fusions/nanobodies, cytokines, growth factors, VLPs and more.
Our manufacturing team is proficient in transference activities, engineering runs, and validation batches, ensuring swift project initiation. Moreover, we have more than 90 analytical methods already validated that can be readily tailored to meet project specifications.
With ISO9001:2015, ISO13485:2016, and cGMP certifications underpinning our manufacturing procedures, we adapt to meet your specific needs. Whether it is delivering prompt R&D or preclinical batches, executing initial cGMP validation batches, or orchestrating full-scale clinical manufacturing campaigns, we ensure compliance and quality at every stage.
Discover more about our CDMO protein services
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53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins. The company provide services from preclinical development to GMP manufacturing, supporting their clients in getting their biological products to market as quickly as possible.
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