Most biotech teams assume GMP readiness begins when a product enters clinical…
Your project is our project, let us demonstrate our commitment, agility and flexibility
Since we are a customer-focused CDMO, we adapt to your needs. Our scientists can develop and release safe biological products in time, within a set budget and following the quality standards of your choice.
53Biologics is an end-to-end CDMO for your preclinical and clinical projects, with extensive experience in decoding biologics production (plasmid DNA and recombinant proteins) providing services of cell line generation, banking and characterization, analytical development, process development (USP & DSP) and batches production of both drug substances and drug products.
Our mission is to provide services to different companies, from start-ups to large companies, as well as to other CDMOs, to help their products to reach the market. 53Biologics works in a quick, proactive and efficient way, always ensuring very high-quality standards.
With a wide array of certifications including ISO 9001:2015, ISO 13485:2016, ISO 14001:2015, and GMP. Because of that, we ensure adaptability to every stage of your journey, from initial development to cGMP production of your biologics.
We boast a total of 4500 sqm constructed in two different buildings, with an additional 10,000 sqm reserved for future expansions. Our facilities span 500 sqm dedicated to development activities, 1400 sqm allocated for cGMP manufacturing operations and 400 sqm for analytical testing. Furthermore, our cGMP warehouse covers 400 sqm.
"53Biologics wins 2025 SME of the Year Award for its excellence and and the economic and social impact"
"Since its founding, the company has promoted Spanish biotechnology and now operates in two buildings"
"New 1,500-square-foot facility houses the QC and molecular biology laboratories expanding their capacity by more than 20%"
"53Biologics new production line boasts a 2000L reactor, making it one of the largest of its kind in the world"
"More than 90% of its customers are international. In fact, 50% is American and the other half is European"
"Fast-growing CDMO based in Spain with extensive experience in biologics production from plasmid DNA to proteins"
"53Biologics helps prevent vaccine shortages, preparing the world for potential health crises such as COVID-19"
"CDMO based in Spain with extensive experience in decoding biologics production, from DNA to proteins and with GMP certified"
At 53Biologics we are experts in recombinant protein manufacturing. Our multidisciplinary team combines the experience in Molecular Biology, Microbiology, Fermentation and Protein Biochemistry to drive efficient production processes. In addition, our brand-new facilities incorporate the most advanced technologies, including single-use equipment for mammalian production and glass and stainless steel systems for microbial expression at different scales.
As a customer-focused CDMO, we prioritize flexibility and adaptability, ensuring that our protein manufacturing services are fully tailored to meet our clients’ diverse requirements in terms of both timelines and quality standards.
From early development to commercial manufacturing, we offer a range of manufacturing capacities under GMP and non-GMP conditions. Additionally, we provide comprehensive support from strain and cell line development to process and analytical development, ensuring efficient and innovative solutions for complex challenges. With a proven track record in producing various proteins for different applications, we are committed to delivering excellence throughout your project’s lifecycle
If your protein is produced by a microbial host:
If your protein is produced by a mammalian host:
Your project is our project, let us demonstrate our commitment, agility and flexibility
At 53Biologics, we specialize in delivering exceptional plasmid DNA production services, leveraging our unparalleled expertise in working with E. coli. Starting from the strain construction and cell banking services characterizing and storing different cell banks for our customers, followed by upstream and downstream process development support ensuring consistent and reliable outcomes, to the final pDNA manufacturing services, 53Biologics will support you in advancing your R&D and manufacturing objectives. Our pDNA services comes with outstanding quality control and documentation support as requested.
We adapt to your needs on time, amounts and following the quality standards of your choice as the customer-focused CDMO that we are.
We would love to hear from you!
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