53Biologics Facilities

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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. 

Different Production Lines for Different Needs

With more than 2200 sqm, our state-of-the-art facilities include microbial and mammalian manufacturing lines for non-GMP and cGMP biologics production. Our cutting-edge cGMP production lines are equipped with the most recent single-use technologies to offer flexible manufacturing capacities and short turnaround times. 53Biologics’ team of highly qualified professionals have collectively managed the production of over 500 different proteins.

Line 1 - Up to 500L non-GMP

Our non-GMP production boasts versatile capabilities with a reactor of 100L and another one of 500L. 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 microbial and from 50 to 200L for mammalian. For the Downstream, this line has centrifuge and high pressure homogenization units to feed single use tangential flow filtration and chromatography equipments.

53Biologics facilities

Line 3 - Up to 2000L cGMP

At the forefront of large-scale biomanufacturing, our Line 3 is tailored for microbial culture, able to reach 2000L 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.

Quality Control Labs

Our facilities include more than 400 sqm of fully equipped with most advanced instruments and equipment complying cGMP requirements. For example, these labs count with most updated equipment like HPLC, UPLC with or without MS, bioanalyzers, thermal cyclers for PCR or qPCR, spectrophotometers, plate readers, among other auxiliary equipment like analytical scales, ovens, pH meters,…

Thanks to our expert technical team with over 15 years’ experience, we have +80 analytical methods available and most of them already validated. In addition, we are able to develop process-specific analytics.

analytical labs
process development

Process Development Labs

The Process Development Facilities are equipped with a variety of industrial solutions, including glass, stainless steel, and single-use bioreactors from 1 to 30L. All the different upstream scales, counts with the associate downstream like HPH, centrifuges, depth filtrations, TFF and chromatography equipment.

This process development service is tailored to each client’s specific needs and can be conducted either prior to cGMP production launch or as part of technology transfer from the client’s facilities to ours. Our customer-centric approach ensures efficient, robust, and scalable process development, supported by cutting-edge facilities and equipment.

cGMP Warehouse

This area encompasses a variety of storage rooms, ranging from ultra-low temperatures of -80ºC to controlled environments at -20ºC, 4ºC, and 15-25ºC. Additionally, we count with climatic chambers ensuring optimal conditions for sensitive materials. Our storage facilities also include designated zones for reception and shipment handling, streamlining logistics processes.

Compliant with cGMP regulations, our storage and dispensing areas are meticulously organized to ensure the integrity and traceability of materials throughout their lifecycle.


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