Decoding Biologics Production

53Biologics is a CDMO for your preclinical and clinical projects, from plasmid DNA to proteins

Experts in Biologics Production

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 standars of your choice.

53Biologics...

53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins. The company provide services from preclinical development to GMP manufacturing, supporting their clients in getting their biological products to market as quickly as possible.

Our mission is your mission. We strive for excellence in our CDMO services to be your partner and give you the best support to bring your biotherapeutic to realization.

53Biologics

Quality Commitment

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.

 

More than 4500 sqm already constructed

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 facilities

The Media Talks About 53Biologics

CDMO Services for Proteins

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

Your project is our project, let us demonstrate our commitment, agility and flexibility

Plasmid DNA Services

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.

Interested In Our Services?

We would love to hear from you!

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    Blog

    You have access to the knowledge that our CDMO has compiled

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