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Biologics Manufacturing Facilities Built to Keep Programs Moving
Two purpose-built facilities engineered to take biologics from supporting biologics from preclinical to commercial manufacturing.
Our Facilities
Our facilities were designed around one objective: helping biologics programs move forward with fewer handovers, greater scientific continuity and the flexibility to adapt as projects evolve. Located in the Boecillo Technology Park (Valladolid, Spain), our integrated campus brings together process development, GMP manufacturing, analytical laboratories and aseptic Fill & Finish, allowing our scientific teams to remain closely involved throughout the entire program.
2
Purpose-built buildings
3,400 sqm
Development, manufacturing & analysis area
4
Manufacturing lines
≤ 2000L
GMP manufacturing capacity
Two Facilities. One Connected Biologics Platform.
Headquarters
2,200 sqm
Manufacturing lines (GMP and non GMP)
Quality & Control Labs
1,200 sqm
Storage & warehousing
Different Manufacturing Lines for Different Needs
Non-GMP
Up to 500L
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.
GMP
Up to 200L for
Microbial
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.
GMP
Up to 2000L for
Microbial
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.
GMP
Up to 2000L for Mammalian
Optimized for flexibility and scalability, our mammalian production line features single-use bioreactors up to 200L and 2000L, enabling efficient transition from development to GMP manufacturing. Downstream processing is supported by a shared single-use DSP platform with our microbial Line 3, including filtration and chromatography systems, ensuring robust and high-quality production.
Everything a Biologics Program Needs, Under One Roof
Aseptic filling area
To provide a seamless manufacturing experience, at 53Biologics we offer integrated fill & finish capabilities designed to support clinical and commercial supply. Our infrastructure includes an isolator-based aseptic filling system, SciLog® technologies, flexible filling formats for vials, bottles and single-use bags, and lyophilization capabilities for solid dosage forms. This integrated approach reduces operational complexity, minimizes technology transfers, and helps ensure a reliable and efficient path to market.
Quality control labs
Our facilities include more than 400 sqm of fully equipped with most advanced instruments and equipment complying GMP requirements. This area counts with 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. We have +90 analytical methods available and most of them already validated. In addition, we are able to develop process-specific analytics.
Process development area
Equipped with a broad range of development-scale technologies, including glass, stainless steel and single-use bioreactors from 1 to 50 L. Each upstream scale is supported by a complete set of downstream processing equipment, including high-pressure homogenizers, centrifuges, depth filtration systems, TFF and chromatography platforms, enabling seamless process development and scale-up.
GMP 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.
Technology Supporting Reliable Manufacturing
The following highlights key equipment supporting our development, manufacturing and analytical capabilities. Combined with our scientific teams, it enables scalable, reliable and flexible biologics manufacturing across the entire project lifecycle.
Equipment
Application
Capability
Stainless-Steel Fermentation Systems
Microbial Manufacturing
Scalable fermentation from seed train to 2,000 L GMP production
Single-Use Bioreactors (Sartorius Biostat STR & Thermo HyPerforma)
Mammalian Manufacturing
Flexible process development and GMP production up to 2,000 L
AMBR® High-Throughput Bioreactor Systems
Mammalian Process Development
Parallel bioprocess optimization and rapid process screening
Industrial Centrifugation & High-Pressure Homogenization (GEA)
Cell Harvest & Disruption
High-capacity clarification and microbial cell disruption at scale
ÄKTA™ Chromatography Platforms
Downstream Processing
Process development and single-use GMP purification
Tangential Flow Filtration (TFF) Systems
Downstream Processing
Concentration, diafiltration and buffer exchange from development to GMP scale
Grade A Aseptic Isolator
Drug Product Manufacturing
EU GMP Annex I-compliant aseptic filling for vials, bottles and bulk containers
Lyophilizer
Drug Product Manufacturing
Freeze-drying of biologics to enhance product stability and shelf life
SciLog® Bulk Filling System
Drug Product Manufacturing
Closed-system filling of single-use bags and bulk drug product containers
Advanced QC & Analytical Laboratories
Quality Control
HPLC/UHPLC, qPCR, Bioanalyzer, LC-MS (QDa), microbiology and molecular biology for in-process control and release
QUALITY & COMPLIANCE
Quality Built Into Every Stage
Scientific expertise only creates value when supported by robust quality systems. Ours are certified to ISO 9001, ISO 13485, GMP and ISO 14001 — giving clients confidence in every batch we release.
ISO 9001
Quality Management System
ISO 13485
Medical Device Quality Management
GMP
Good Manufacturing Practices
ISO 14001
Environmental Management Systems
Inside Our Facilities
Our integrated biologics manufacturing campus in Valladolid.
Stainless-steel fermentation suites for scalable microbial production.
Single-use bioreactor technology for flexible mammalian manufacturing.
Grade A isolator for the aseptic filling of vials.
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Let's Build the Right Manufacturing Path Together
Whether your program is entering development, preparing for GMP manufacturing or needs clinical supply, our facilities are designed to support your next step.