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About 53Biologics
Your end-to-end biologics CDMO, built to keep programs moving.
WHO WE ARE
We Are 53Biologics
We work side by side with our clients. Not at a distance, but in the detail, in the challenge, in the moments that matter. Trust grows through openness, responsiveness and a genuine commitment to helping them succeed.
We are courageous. We aren't afraid to take on challenges or approach things differently. With determination, technical depth and a proactive mindset, we unlock progress where others may hesitate.
We take ownership, individually and collectively.
We treat every project as if it were our own. When things get difficult, we don't step back. Instead, we step in, stay engaged and take responsibility for the outcome.
And we keep advancing. We are driven to improve, to do better and to go further, step by step. Because progress is built over time and we are committed to moving our clients, and ourselves, forward.
This is how we work.
This is what makes us 53Biologics.
5’ to 3’ - The Meaning of the Name
Our name is intentional, just like everything we do. DNA is “read” in a specific direction, like we read letters and words from left to right to reproduce a message. Similarly, the information encoded in DNA is translated in one direction, from the five-prime end (5′) to the three-prime end (3′). This reading frame is fundamental to understanding how genetic information becomes a functional protein. To clarify, the initial designations refer to the number of the carbon atom in a deoxyribose molecule to which a phosphate group bonds. However, at 53Biologics, these designations represent more than a biological principle. They reflect the way we translate information, from DNA into protein, and, ultimately, transform encoded information into reality.
A CDMO Partner You Can Trust
We have successfully developed processes for enzymes, ancillary reagents, growth factors, virus-like particles and vaccines.
1
Team from gene to GMP
10+
Years of hands-on experience in biomanufacturing
150+
Documented projects already executed
4
Manufacturing lines
OUR JOURNEY
Last Years Evolution
2022
Microbial capacity expansion with fermentation capacity up to 200 L
2023
New building acquired to expand the Quality Control laboratories
Expansion of microbial capacity with fermentation capacity up to 2000 L
Improvement in fill and finish capacities following the installation of a Grade A isolator
2024
Expansion of mammalian capacity with fermentation capacity up to
200 L
2025
53Biologics wins European CDMO Leadership Award for biologics strengthening external recognition
2026
Expansion of mammalian biologics capacity with fermentation capacity up to 2000 L
Improvement in fill and finish capacities following the installation of a lyophilizator
MANAGEMENT TEAM
The People Behind 53Biologics
Pablo Gutiérrez
CEO and Founder
Carmen Martínez
Chief Operations Officer
Francisco Reyes
Business Development Director
Elena Hernández
Project Management Director
Emilio Gutiérrez
Chief Financial Officer
Carlos Blázquez
Engineering Director
Andrea García
Quality Assurance Director
Sergio García
Human Resources Director
Adrián Pérez
Supply Chain Director
OUR VALUES
What Drives Us
We Work Side by Side
We collaborate closely with our clients, working through problems together rather than at a distance. Becasue strong partnerships are built on openness, responsiveness and a genuine commitment to success.
We Are Courageous
We aren't afraid to take on challenges or approach things differently. Driven by determination, technical depth and a proactive mindset, we unlock progress where others hesitate.
We Take Ownership
Each project is approached with individual and collective ownership, as if it were our own. Throughout the project, the focus stays on take responsibility for outcomes, not just on delivering our part.
We Keep Advancing
We are always looking for ways to improve, do better and go further, step by step. That ambition is part of how we grow, strengthen our capabilities and help our clients move forward with confidence.
OUR FACILITIES
Infrastructure Built for Biologics Production
Located in the Boecillo Technological Park in Valladolid, Spain, our facilities bring together development laboratories, multiple GMP manufacturing lines, quality control labs, warehousing and aseptic fill-finish within one integrated operating model. As a result, clients can reduce transfer points, streamline operations, and scale into GMP with less disruption. At the same time, this integrated setup supports greater continuity and coordination throughout the manufacturing journey.
2 buildings
4,500+ sqm
4 manufacturing lines
Why Choose 53Biologics as Your CDMO Partner?
We Work Side By Side
Work directly with the scientists and technical experts shaping your program. From the outset, close collaboration, transparent communication and shared access to the data help keep decisions aligned with the science and the process, while also keeping your next development milestone clearly in view. Throughout the program, this close connection helps maintain alignment as your needs evolve.
We Are Courageous
Complex biologics do not always follow a standard route. For this reason, we bring specialist scientific expertise and a proactive problem-solving mindset to assess technical risks and address process challenges. At the same time, where more rigid models may hesitate, we focus on developing practical solutions that keep the process moving forward.
We Take Ownership
We treat every program as if it were our own, staying accountable from early development through GMP manufacturing and Fill & Finish. In turn, our integrated capabilities, robust quality systems and fewer external handoffs help protect process knowledge, compliance and continuity.
We Keep Advancing
As data, priorities and requirements evolve, we therefore adapt the scope, pace and technical pathway accordingly to keep progress moving. Moreover, our lean operating model combines efficient decision-making, scalable capabilities and clear cost-to-value, while maintaining the scientific and quality standards that guide every project.
One Connected Pathway
Cell line development, cell banking, process development, analytical support, manufacturing and fill & finish connected under one roof. Therefore fewer external handoffs help preserve process knowledge, simplify coordination and reduce transfer risk as your program progresses.
The Right Quality Fit
Choose the quality framework that matches your program stage, depending on whether you need an ISO 9001 or ISO 13485 environment or GMP. Accordingly, this right-sized approach helps you avoid unnecessary complexity and cost, so that you can maintain the scientific rigor and compliance your product requires.
CERTIFICATIONS
Quality & Compliance
Quality is at the core of everything we do. To support this commitment, our EMA-inspected facilities operate under authorization ES/091/21 and are supported by ISO 9001, ISO 13485, Kosher, Halal and GMP certifications. In addition, with more than 25 successful audits in the last two years. Consequently, clients can rely on proven compliance, consistency, and regulatory confidence.
ISO 9001
Quality management system
Suited to Research Use Only (RUO) needs
ISO 13485
Quality management for medical devices
Suited to ancillary reagents
GMP
Good Manufacturing Practice
Suited to therapeutic proteins
IN THE PRESS
Recognised Across the Industry
PHARMATECH
53Biologics wins 2025 SME of the Year Award for its excellence and its economic and social impact
ABC
Since its founding, the company has promoted Spanish biotechnology and now operates in two buildings
europa press
More than 90% of its customers are international — in fact, 50% American and the other half European
manufacturing chemist
53Biologics' new production line boasts a 2000L reactor, making it one of the largest of its kind in the world
Latest News
Latest From Our Blog
Insights, protocols and perspectives from our scientific team.
October 6, 2026
Engineering Batches: The Run That Can Save Your GMP Campaign
September 24, 2026
How Much Process Development Is Enough Before GMP Manufacturing?
September 8, 2026
Can Your CDMO Handle a Non Standard Protein?
Ready to Move Your Program Forward?
Tell us what you're working on and our team will get back to you within two business days.