Developability Assessment Service

Candidate Selection Before CMC to

Avoid Stability Risk

GenScript Probio provides professional Developability Assessment services for biologics. In the stage of antibody drug discovery and development, the early developability assessment services can evaluate the antibody and protein molecules to identify the potential risks of manufacture and clinical failure.

Developability Assessment is one of the most important evaluation in the development of biologics, which is bridging the drug discovery and CMC.

• Provide the information for the CMC (e.g. cell culture parameters, difficulty in purification, quality attributes, etc.)
• Provide the good candidates, as the practice and application of QbD
• Identify the development risk, estimate the CMC costs and time

Two scenarios are involved in Developability Assessment. For both scenarios, GenScript Probio’s service can identify the potential developability risk and help to select the CMC candidates.

• Screening: multiple candidates, choose the best one to CMC
• De-risking: one candidate of high potential, how hard to develop in CMC