53Biologics is a CDMO specializing in the development and production of biologics. It is a leading company in the biopharmaceutical sector, providing services from preclinical development to GMP manufacturing, helping its clients’ biologic drugs reach the market as quickly as possible.
Want to learn more about us? Visit our website at 53biologics.com
Pablo Gutiérrez, Chief Executive Officer (CEO)
Francisco M. Reyes, Business Development Director
Carmen Martínez, Chief Operating Officer (COO)
Emilio Gutiérrez, Chief Financial Officer (CFO)
Elena Hernandez, Project Management Director
Andrea García, Quality Assurance Director
Sergio Garcia, Human Resources Director
Carlos Blazquez, Engineering Director
Adrian Pérez, Supply Chain Director
• Development of mammalian cell lines and microbial strains
• Production and characterization of cell banks under cGMP and non-GMP standards
• Development, qualification, and validation of analytical methods
• Development and optimization of production processes
• Scale-up of production processes
• Production of plasmid DNA and recombinant protein under cGMP and non-GMP standards
• Characterization and release of Drug Substance (DS) and Drug Product (DP)
• Stability testing for DS and DP
• Fill and Finish
• Flexibility and Agility: 53Biologics provides tailored solutions, adapting microbial and mammalian processes according to the development stage and project objectives.
• Close Collaboration: At 53Biologics, we maintain direct, transparent, and collaborative communication with clients, acting as an extension of their own team.
• Quality Standards: ISO 9001, ISO 13485, and cGMP certifications support 53Biologics’ extensive production capabilities for both biopharmaceutical and diagnostic projects.
• Competitive Pricing: Located in Spain, 53Biologics benefits from lower operational costs compared to CDMOs in other European countries or the U.S., while maintaining international GMP standards. This enables more competitive pricing without compromising quality.
• All Services Under One Roof: From generating the protein- or plasmid DNA-producing strain to GMP production and final product (Drug Product) release.
Companies ranging from startups to large corporations, all within the pharmaceutical or biotechnology sectors.
Changing CDMO Late in Development: What Biologics Teams Should Know
53Biologics
Recombinant Protein Production Under GMP: Key Decisions That Define Success
53Biologics
Why GMP Readiness Starts During Drug Development, Not at Clinical Phase
53Biologics
How to Scale Manufacturing Without Losing Quality or Compliance
53Biologics
53Biologics drives its expansion in GMP biomanufacturing with an investment led by Ren Life Sciences and supported by Inveready
53Biologics
Understanding the Manufacturing Responsibilities for Drug Substances and Drug Products
53Biologics
GMP Manufacturing Pitfalls That Delay Biologics Production (and How to Avoid Them)
53Biologics
GMP Manufacturing with a Biologics CDMO: How to Make the Right Decision at a Critical Stage
53Biologics
Process Validation: The Hidden Key to Operational Excellence in Industry
53Biologics
53Biologics, galardonada con el premio pyme del año 2025 de Valladolid
53Biologics
