53Biologics operates in 2 buildings located in the Boecillo Technological Park in Valladolid, Spain
More than 4.500 sqm already constructed and even more than 10.000 sqm reserved for future expansions.
With more than 2200 sqm, our state-of-the-art facilities include microbial and mammalian pilot plants for process development and different manufacturing lines for non-GMP and cGMP biologics production.
Our cutting-edge GMP production lines are equipped with the most recent single-use technologies to offer flexible manufacturing capacities and short turnaround times.
Our team of highly qualified professionals have collectively managed the production of over 500 different proteins.
The facilities include more than 400 sqm of fully equipped QC labs. For example, these labs count with most updated equipment like HPLC, UPLC with or without MS, bioanalyzers…
The rest space is used as our main storage rooms (from -80ºC to, -20ºC, 4ºC, 15-25ºC), climatic chambers, reception and shipments decks, cGMP storage and dispensing areas.
Thanks to our expert technical team with over 15 years’ experience, we have +75 analytical methods available and most of them already validated. In addition, we are able to develop process-specific analytics.
Line 1- Up to 500L non-GMP
Our non-GMP production boasts versatile capabilities with a reactor of 100 L and another one of 500 L. Both with dedicated centrifuge, high pressure homogenization unit, filtration skids and holders, chromatography equipments, and auxiliary tanks. Whether you’re embarking on early-stage research or scaling up 53Biologics facility is tailored to deliver excellence at every stage.
Line 2- Up to 200L cGMP
Empowering precision in pharmaceutical manufacturing, our line 2 is meticulously designed to meet the highest standards of quality and compliance. It has fermenters from 20 to 200L at the Upstream grade D clean room. For the Downstream, this line has centrifuge and high pressure homogenization units to feed single use tangential flow filtration and chromatography equipments.
Line 3- Up to 2000L cGMP
At the forefront of large-scale biomanufacturing, our Line 3 is able to reach 2000L culture scale. This line is also equipped with centrifuge, high pressure homogenization equipments and single use tangential flow filtration and chromatography equipments to handle the demands of complex and high-volume productions, ensuring the delivery of top-tier pharmaceutical solutions.
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