ABOUT 53BIOLOGICS
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 batch 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 reach the market. 53Biologics works in a quick, proactive, and efficient way, always ensuring very high-quality standards.
INDUSTRY INSIGHTS
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![Blog - GMP Manunfacturing Pitfalls]( "How To Avoid GMP Manufacturing Pitfalls")
Common GMP pitfalls stem from poor scalability, late regulatory planning, weak tech transfer, unsuitable hosts, and inadequate quality systems, delaying biologics production timelines and budgets.
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![Screenshot 2026-04-06 081057]( "Licensed Vs. Unlicensed Cell Lines In Biologics Development")
Choosing licensed vs. unlicensed cell lines impacts development speed, cost, flexibility, and long‑term control, making early strategic evaluation key to efficient biologics development.
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![Screenshot 2026-04-06 081331]( "Understanding Drug Substance and Product Manufacturing")
Understanding drug substance vs. drug product responsibilities helps avoid regulatory issues, technical risks, and delays while improving planning, scalability, and GMP‑compliant execution.
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![Screenshot 2026-04-06 081421]( "Five Tips For A Successful Tech Transfer To A CDMO")
Successful tech transfer depends on solid documentation, early teamwork, clear expectations, proactive risk planning, and experienced partners to keep execution smooth and projects moving on schedule.
CONTACT INFORMATION
53Biologics
13 Louis Proust St.
Boecillo, Valladolid, 47151
SPAIN
Phone: +34 983708973
Contact: Patricia De La Madrid
SOLUTIONS
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![Screenshot 2026-04-06 075255]( "pDNA Manufacturing")
Plasmid DNA services provide customizable development, scalable manufacturing up to 200 L, multiple quality grades, and full workflow support from strain development to fill‑finish and release testing.
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![Screenshot 2026-04-06 075407]( "Microbial Services: Enzymes & Ancillary Reagents Manufacturing")
Microbial enzyme manufacturing delivers fast, scalable production from small to large volumes, with tailored quality, rapid start‑up, and end‑to‑end support for recombinant proteins and reagents.
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![Screenshot 2026-04-06 075658]( "Microbial Services: Protein Manufacturing")
Microbial manufacturing offers scalable, cost‑effective development and GMP production of therapeutic proteins, with strain engineering, 2000 L fermentation, integrated QC, and rapid timelines.
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![Screenshot 2026-04-06 080313]( "Manufacturing Lines")
An integrated manufacturing setup with microbial and mammalian lines, strong segregation and contamination control, plus end‑to‑end support to streamline biologics development.
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![Screenshot 2026-04-06 075128]( "Mammalian Services: Protein Manufacturing")
Sterile, GMP‑compliant fill‑finish services support small‑ to mid‑scale clinical batches across various dosage forms, ensuring rigorous quality control and reliable packaging.
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![Fill&Finish]( "Fill & Finish Services")
Sterile, GMP‑compliant fill‑finish services support small‑ to mid‑scale clinical batches across various dosage forms, ensuring rigorous quality control and reliable packaging.
