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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.
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.
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.
"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"
Delays, rigid processes and scalability uncertainties can slow down your enzymes or API project. At 53Biologics, we remove those barriers. As a customer-focused CDMO, we prioritize flexibility and adaptability, ensuring that our protein manufacturing services are fully tailored to meet our clients’ requirements in terms of both timelines and quality standards, from early development to commercial manufacturing.
Fast timelines, high yields and robust scalability are critical in microbial protein production and that’s exactly where we add value.
Strain Development
Vast experience with E. coli and Pichia pastoris but also many other microbial strains like Bacillus, Saccharomyces and fungal expression systems.
Cell Banking
Fully capable to produce and characterize Master Cell Banks (MCB) and Working Cell Banks (WCB) in our GMP compliant suits.
Process Development and Scale-up
Our team combines deep expertise in fermentation and purification to tackle common challenges such as low expression, inclusion bodies, and downstream bottlenecks.
GMP Manufacturing
From preclinical to commercial supply, our GMP microbial manufacturing service delivers high quality proteins you can trust.
Fill & Finish
Aseptic Fill & Finish services supporting your product from preclinical batches through to commercial supply.
When product quality, consistency and regulatory readiness are non-negotiable, 53Biologics can deliver a highly controlled and experienced approach working with mammalian systems.
Cell Line Development
We collaborate with recognized partners to develop mammalian cell lines based in CHO and HEK293.
Cell Banking
Develoment and characterization of Master Cell Banks (MCB) and Working Cell Banks (WCB) in our GMP compliant suites.
Process Development
We design and optimize mammalian processes on CHO and HEK293 platforms so you can achieve the right balance of yield, cost, robustness, operability and scalability.
GMP Manufacturing
You can rely on 53Biologics for GMP manufacturing of mammalian cell-derived APIs, like antibodies, mAbs, biosimilars or growth factors.
Fill & Finish
Aseptic Fill & Finish services supporting your product from preclinical batches through to commercial supply.
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!
Please note that job applications submitted through this form will not be considered. Use the Careers page.
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