Drug discovery is a time-consuming process that includes identification of candidate molecules according to chosen parameters, product characterization, screening, range-finder studies and competitor product comparisons. Data developed during the initial research stage is used to determine whether or not to proceed with the drug to an IND submission, and ultimately on to clinical trials. Charles River Biopharmaceutical Services (BPS) offers an initial evaluation (characterization, stability and safety) of your product while following international regulatory guidelines and operating to either current Good Manufacturing Practice (cGMP) or Good Laboratory Practice (GLP).
Appropriate formulation and dosing regimens are determined during the drug development process. We offer confirmational studies to accelerate your product development. Through our multiple international sites and extensive client collaboration, Charles River has developed and validated an array of assays to expedite the development process.
Product and Services
- GLP/cGMP/research and development in vivo testing (discovery)
- Competitor comparative studies
- Proof-of-concept studies
- Product characterization
- Range-finder studies
- cGMP in vitro and in vivo testing (discovery and development)
- Assay validation
- Cell line characterization
- Confirmation studies
- Protein characterization studies
- Molecular biology testing
- Product development
- Technology transfer
- Custom methods development
- In vivo challenge studies (bacterial and viral)
- cGMP/GLP in vitro testing