Custom Biologics
Exceptional Science. Uncompromising Quality.
Global bioanalytical CRO offering GLP-compliant assay development, validation, and testing for large-molecule biopharmaceuticals. Supports pre-clinical/CMC and clinical stages, including GMP-lot and market release testing.
Phases
Services
Modalities
Technical specifications & accreditations
Accreditations
About this organization
Custom Biologics is a bioanalytical contract research organization that provides specialized, GLP-compliant assay development, validation, and testing services for biopharmaceutical drug development.
Services and focus
- GLP-compliant bioanalytical testing for large-molecule (biologic) drugs
- Assay development and validation
- GMP-lot and market release testing
- Drug-specific tests
- Genomics DASL-Rapid™ offering
- Support for pre-clinical/CMC and clinical stages of drug development
The company also publishes resources on topics such as biosimilar bioanalysis, AAV potency assays in preclinical CMC, and pharmaceutical quality systems.
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