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53Biologics is a fast-growing CDMO based in Valladolid (Spain) with extensive experience in biologics production, from DNA to proteins
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.
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.
We started offering customized protein production and process development services.
We increased our production capacity by acquiring a 100L and 500L fermenter and we were also awarded ISO 9001.
53Biologics started to offer our current CDMO services for the biopharma sector.
We achieved GMP certification and start ofeering GMP Cell Banking Services as well as GMP Manufacturing
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 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.
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.
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.
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.
