53Biologics
53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins. The company provides services from preclinical development to GMP manufacturing, supporting clients in bringing their biological products to market quickly. Their mission is to support clients at every stage of drug development, emphasizing quality, innovation, and regulatory compliance. They operate state-of-the-art facilities with extensive capabilities in biologics production, including plasmid DNA, proteins, and cell banking, with a strong commitment to quality standards such as ISO certifications and GMP.
Industries
Nr. of Employees
medium (51-250)
53Biologics
Products
Aseptic Fill & Finish
ISO 7 facility with Grade A isolator technology providing aseptic fill and finish solutions tailored to diverse molecules and formats, supporting clinical trial batches and small commercial batches.
Aseptic Fill & Finish CDMO Services
Comprehensive aseptic fill and finish services supporting both liquid and lyophilized final dosage forms for biologic drug products.
Mammalian Cell
Develop a mammalian expression system designed for manufacturability, scalability and smooth transfer into process development supporting CHO, HEK and other mammalian programs.
Mammalian Cell Banking Services
Generate robust Master and Working Cell Banks for recombinant protein production with a strategy aligned to your development stage, manufacturing goals and regulatory pathway.
pDNA Cell Banking Services
Establish a well-characterized and traceable cell bank providing a consistent biological starting point for plasmid DNA manufacturing.
CDMO Services for Microbial Proteins
Custom CDMO services providing strain development, cell banking, process development, contract manufacturing, analytical services, and fill-finish for microbial proteins using E. coli, P. pastoris, Bacillus, and fungal systems.
Aseptic Fill & Finish
ISO 7 facility with Grade A isolator technology providing aseptic fill and finish solutions tailored to diverse molecules and formats, supporting clinical trial batches and small commercial batches.
Aseptic Fill & Finish CDMO Services
Comprehensive aseptic fill and finish services supporting both liquid and lyophilized final dosage forms for biologic drug products.
Mammalian Cell
Develop a mammalian expression system designed for manufacturability, scalability and smooth transfer into process development supporting CHO, HEK and other mammalian programs.
Mammalian Cell Banking Services
Generate robust Master and Working Cell Banks for recombinant protein production with a strategy aligned to your development stage, manufacturing goals and regulatory pathway.
pDNA Cell Banking Services
Establish a well-characterized and traceable cell bank providing a consistent biological starting point for plasmid DNA manufacturing.
CDMO Services for Microbial Proteins
Custom CDMO services providing strain development, cell banking, process development, contract manufacturing, analytical services, and fill-finish for microbial proteins using E. coli, P. pastoris, Bacillus, and fungal systems.
Services
Contract manufacturing of plasmid DNA from development through clinical/commercial supply, including upstream/downstream processing and pDNA-specific QC.
End-to-end protein CDMO services including strain/cell line development, process development, scale-up and GMP/non-GMP manufacturing for microbial and mammalian proteins.
Generation, characterization and GMP storage of Master, Working and Research Cell Banks for microbial and mammalian hosts, with full characterization services and long-term storage.
Engineering and selection of microbial and mammalian expression hosts, design of expression constructs and optimization for productivity and stability.
Customized upstream and downstream process development including fermentation optimization, purification scheme design and scale-up readiness.
Method development, qualification, validation and transfer for release and stability testing; routine QC testing and support for method-specific analytics.
Contract manufacturing of plasmid DNA from development through clinical/commercial supply, including upstream/downstream processing and pDNA-specific QC.
End-to-end protein CDMO services including strain/cell line development, process development, scale-up and GMP/non-GMP manufacturing for microbial and mammalian proteins.
Generation, characterization and GMP storage of Master, Working and Research Cell Banks for microbial and mammalian hosts, with full characterization services and long-term storage.
Engineering and selection of microbial and mammalian expression hosts, design of expression constructs and optimization for productivity and stability.
Customized upstream and downstream process development including fermentation optimization, purification scheme design and scale-up readiness.
Method development, qualification, validation and transfer for release and stability testing; routine QC testing and support for method-specific analytics.
Expertise Areas
- Plasmid DNA manufacturing
- Recombinant protein manufacturing
- Cell banking and cell line development
- Upstream and downstream process development
Key Technologies
- Single-use bioreactors
- Glass and stainless-steel bioreactors
- Tangential flow filtration (TFF)
- High-pressure homogenization (HPH)
News & Updates
Representation at BIO International Convention in Boston, USA, to showcase expertise in biologics production from DNA to proteins.
Discussion on the increasing importance of CDMOs in biologics development and manufacturing, highlighting 53Biologics' role in the industry.
Exploration of challenges and strategies in scaling up protein manufacturing, emphasizing process robustness and regulatory compliance.
Overview of GMP biologics manufacturing advancements and 53Biologics' innovative approaches in 2025.
Analysis of common obstacles in scaling biologics and how 53Biologics addresses these challenges.
Role of plasmid DNA in gene therapy, vaccines, and biopharmaceuticals, with emphasis on quality manufacturing.
Representation at BIO International Convention in Boston, USA, to showcase expertise in biologics production from DNA to proteins.
Discussion on the increasing importance of CDMOs in biologics development and manufacturing, highlighting 53Biologics' role in the industry.
Exploration of challenges and strategies in scaling up protein manufacturing, emphasizing process robustness and regulatory compliance.
Overview of GMP biologics manufacturing advancements and 53Biologics' innovative approaches in 2025.
Analysis of common obstacles in scaling biologics and how 53Biologics addresses these challenges.
Role of plasmid DNA in gene therapy, vaccines, and biopharmaceuticals, with emphasis on quality manufacturing.