About 53Biologics

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53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins. 

53Biologics is a biopharma leading company providing services from preclinical development to GMP manufacturing, supporting their clients in getting their biological products to market as quickly as possible.

Our history

53Biologics was born from a group of scientists who believe that biologics would shape the future of the pharmaceutical industry. The commitment and will of our employees have been the driving force behind 53Biologics’ continual mission to become a great CDMO through each success.

Right now, with a team of almost 60 dedicated people, 53Biologics is focused on providing end-to-end services to support our customers at all stages of their drug development, from R&D to commercial manufacturing. We have managed to become a great CDMO, making our own mission the mission of our customers in every project.

2016 - Beginnings

We started offering customized protein production and process development services.

2018 - Gaining Quality and Capacity

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

2019 - CDMO Sevices

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

2020 - GMP Certification

We achieved GMP certification and start offering GMP Cell Banking Services as well as GMP Manufacturing at 200L scale.

2022 - Acquisition of New Building

53Biologics acquires a new building dedicated primarily to quality control and storage. We achieved ISO 13485 certification for Medical Devices manufacturing.

2024 - Expansion of GMP Area

We are increasing our production capacity with the opening of a new 2000L GMP plant, creating more ISO 7 and ISO 8 clean rooms.

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.

Flexible CDMO for biologics production

Our state-of-the-art facilities in Spain allow us to support biopharma companies from preclinical development to clinical production of their innovative therapies, like antibodies, enzymes, vaccines and APIs. We are not afraid of handling challenging projects such as producing hard-to-express proteins or developing unconventional purification schemes.

53Biologics counts with two buildings and three different manufacturing lines focused in early clinical phases.

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