Aragen Bioscience
Contract research and development partner for biologics and preclinical services. Offers end-to-end biologics capabilities including cell line development and cell banking, upstream and downstream process development, scale-up and bioproduction (stainless-steel and single-use systems), bioanalytical and protein analytics, GLP pharmacokinetic and immunogenicity assessment, and preclinical in vivo efficacy testing using validated disease models. Produces technical resources and on-demand webinars on process intensification, assay development, model systems and manufacturing best practices.
Industries
Nr. of Employees
Very Large (1000+)
Aragen Bioscience
Morgan Hill, California, United States, North America
Products
Cell Line Development
Provides integrated services for developing recombinant cell lines, including transfection, clone selection, and optimization to produce biologics efficiently.
Protein Expression and Purification
Offers protein production and purification services for various mammalian proteins, ensuring correct activity and purity at required scales.
Analytical Services
Delivers comprehensive analytical testing and characterization for biotherapeutics, including routine assays, bioassay development, and stability studies.
Process Development and Characterization
Focuses on optimizing upstream and downstream processes for biologics production, including scale-up and bioanalytical support.
GMP Manufacturing Services
Provides cGMP-compliant clinical drug substance manufacturing using single-use bioreactors ranging from 50L to 2000L, scalable to 5000L.
Preclinical Efficacy Testing
Conducts in vitro and in vivo preclinical testing using validated cell lines and animal models across multiple therapeutic areas.
Cell Line Development
Provides integrated services for developing recombinant cell lines, including transfection, clone selection, and optimization to produce biologics efficiently.
Protein Expression and Purification
Offers protein production and purification services for various mammalian proteins, ensuring correct activity and purity at required scales.
Analytical Services
Delivers comprehensive analytical testing and characterization for biotherapeutics, including routine assays, bioassay development, and stability studies.
Process Development and Characterization
Focuses on optimizing upstream and downstream processes for biologics production, including scale-up and bioanalytical support.
GMP Manufacturing Services
Provides cGMP-compliant clinical drug substance manufacturing using single-use bioreactors ranging from 50L to 2000L, scalable to 5000L.
Preclinical Efficacy Testing
Conducts in vitro and in vivo preclinical testing using validated cell lines and animal models across multiple therapeutic areas.
Services
Comprehensive biologics services
End-to-end biologics support including cell line development, clone selection, cell banking, upstream and downstream process development, and analytics.
Preclinical efficacy testing
In vivo efficacy studies using validated disease models across multiple therapeutic areas, executed with on-site vivarium support.
Bioanalytical, PK/ADA and protein analytics
Assay setup, method development and validation, GLP pharmacokinetic and ADA studies, and protein characterization to support pharmacology and CMC packages.
Downstream process development and purification
Optimization of purification workflows including membrane chromatography and aggregate removal techniques for monoclonal antibodies.
GMP tech transfer and clinical manufacturing support
Tech transfer to cGMP facilities and support for pilot- and clinical-scale manufacturing using stainless-steel and single-use systems.
Technical content and on-demand webinars
On-demand webinars, whitepapers and brochures focused on process development, analytics, preclinical models and biologics development best practices.
Comprehensive biologics services
End-to-end biologics support including cell line development, clone selection, cell banking, upstream and downstream process development, and analytics.
Preclinical efficacy testing
In vivo efficacy studies using validated disease models across multiple therapeutic areas, executed with on-site vivarium support.
Bioanalytical, PK/ADA and protein analytics
Assay setup, method development and validation, GLP pharmacokinetic and ADA studies, and protein characterization to support pharmacology and CMC packages.
Downstream process development and purification
Optimization of purification workflows including membrane chromatography and aggregate removal techniques for monoclonal antibodies.
GMP tech transfer and clinical manufacturing support
Tech transfer to cGMP facilities and support for pilot- and clinical-scale manufacturing using stainless-steel and single-use systems.
Technical content and on-demand webinars
On-demand webinars, whitepapers and brochures focused on process development, analytics, preclinical models and biologics development best practices.
Expertise Areas
- Cell line development and cell banking
- Upstream process development and scale-up
- Downstream purification and membrane chromatography
- Bioproduction on single-use and stainless-steel systems
Key Technologies
- CHO mammalian expression platforms
- Micro-bioreactor systems for process development
- Single-use and stainless-steel bioreactors (fed-batch)
- Membrane chromatography for antibody capture and polishing