True Flexibility for your Fill and Finish needs
In our ISO 7 facility with Grade A isolator technology, we provide aseptic fill and finish solutions tailored to diverse molecules and formats. From enzymes, vaccines and monoclonal antibodies to small molecules, we support clinical trial batches with semi-automatic filling, labeling, packaging, batch release, and GMP storage.
Our Fill & Finish facility is operated under 53Biologics’ corporate Quality Management System, already inspected and approved for GMP operations. The new isolator-based filling line has been designed following EMA Annex 1 guidelines.
We apply the same rigorous quality principles to every project, ensuring aseptic conditions, reliable documentation, and full traceability from clinical to commercial supply.
With this flexible setup, 53Biologics can support a wide range of molecule types, including pDNA, enzymes, monoclonal antibodies, vaccines, and other biologics and non-Biologics. Our Fill & Finish services are particularly well-suited for orphan drugs, early-phase clinical studies and small commercial batches, where flexibility and reliability are critical.
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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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