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53Biologics is a fast-growing CDMO based in Valladolid (Spain) with extensive experience in biologics production, from DNA to proteins

Why we call ourselves 53Biologics

The story begins with the molecular instructions for life or in other words… DNA. As you well know, DNA is a structure that encodes the biological information of all organisms. This pattern is “read” from the five-prime end (5′) to the three-prime end (3′), but for us, this way of reading is so much more than a simple transcription process, it is our beginning, because the production of any biologic begins with 53.

Who we are?

A group of scientists who believe that biologics would shape the pharmaceutical industry’s future created 53Biologics. The commitment and will of our employees have been the driving force behind 53Biologics’ continual mission to become a great CDMO through each success. Our day-to-day work is founded on the desire to help our clients in their mission.

We welcome our customers with the same philosophy and brand of excellence. We are a customer-centric partner who believes that people and their needs come first. Our team is dedicated to providing customized solutions to overcome your unique challenges. 53Biologics is a CDMO that provides process development and GMP manufacturing.

Our state-of-the-art facilities in Spain allow us to support biopharma companies from preclinical to commercial production of their innovative therapies. We welcome you to visit us and meet our people.

With a proven track record of solving difficult problems, we are uniquely positioned to handle challenging projects such as producing hard-to-express proteins or developing unconventional purification schemes.

Our history

2016
Inception of 53Biologics

We started offering customized protein production and process development services.

2018
Gain in quality and capacity

We increased our production capacity by acquiring a 100L and 500L fermenter and we were also awarded ISO 9001.

2019
CDMO Services

53Biologics started to offer our current CDMO services for the biopharma sector.

2020
53Biologics become GMP certified

We achieved GMP certification and start ofeering GMP Cell Banking Services as well as GMP Manufacturing

2022
Acquisition of new building and expansion of GMP area

53Biologics acquires a new building dedicated primarily to quality control and started the expansion of their GMP area to create more ISO 7 and ISO 8 clean rooms an offer 2000L production.

Our Mission

Our mission is your mission. We strive for excellence in our services to be your perfect CDMO partner and help you achieve your objetives. Our success is tied to yours. That is the reason why we are passionate about accompanying our clients in  their  paths  through their biologics production.

Our Values

All our people at 53Biologics operates under the following values: flexibility, integrity, passion, and transparency to build long-lasting relationships with our clients and complete their projects successfully. We embrace our corporate values and we reflect them in our daily routine.

Our Team

We are highly qualified and motivated scientists with wide experience across all stages of the biopharmaceutical value chain. We strongly believe in teamwork and our collaborative spirit is the key to our success in biologics manufacturing. We welcome you to visit us and meet our people.

Worldwide CDMO

It is crucial that our processes, quality, and governance never waver in this highly regulated sector, which is overseen by international GCP, GLP and GMP quality standards. Our track record of regulatory inspections supports 53Biologics’ unwavering commitment to quality and safety standards following ICH guidelines. We are also approved by the FDA in the US and the EMA in Europe.

Discover more about 53Biologics services

Plasmid DNA Services

We provide plasmid DNA production services to fulfill your requirements and accelerate your advanced therapies production.

mRNA Services

We are working to cover the entire mRNA value chain, from DNA template generation and linearization to RNA purification.

Protein Services

From finding the most suitable host to contract manufacturing, 53Biologics will make the most of your protein of interest.

Contact Us!