53Biologics Facilities

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53Biologics operates in 2 buildings specialized in process development and cGMP manufacturing.

Both facilities are located in the Boecillo Technological Park in Valladolid, Spain.

Development & cGMP Manufacturing Facilities

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.

Quality Control Labs and cGMP Warehouse

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.

Different Production Lines for Different Needs

100 L
Line 1 - non-GMP

Our non-GMP production boasts versatile capabilities with a reactor of 100 L and another one of 500 L. Whether you’re embarking on early-stage research or scaling up 53Biologics facility is tailored to deliver excellence at every stage.

100 L
Line 2 - cGMP

Empowering precision in pharmaceutical manufacturing, our GMP production plant features a sophisticated 200L reactor, meticulously designed to meet the highest standards of quality and compliance.

1000 L
Line 3 - cGMP

At the forefront of large-scale biomanufacturing, our GMP production facility boasts a robust 2000L reactor, equipped to handle the demands of complex and high-volume productions, ensuring the delivery of top-tier pharmaceutical solutions.

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