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3 developability assessment packages in R&D stage
• In silico developability analysis
• In vitro developability assay
• Manufacturability assessment
The developability criteria are determined by four key attributes: homogeneity, stability, solubility, and specificity. Attributes of poor developability result in unfavorable physicochemical properties, leading to issues such as subpar performance in metabolism, efficacy, and immunogenicity during process development and clinical trials. Therefore, it is crucial to consider developability properties during the early stages of drug discovery to mitigate the risk of manufacturing failures.
GenScript ProBio offers 3 developability assessment packages for antibody drug candidates at different discovery stages to identify the potential risks of manufacture and clinical failure.
1 weeks
2-3 weeks
6-8 weeks
GenScript ProBio provides the developability anlaysis report comprises three parts: the immunogenicity analysis, post-translational modification (PTM）and antibody aggregation analysis. If high-risk issues are identified, our experts have an extensive antibody engineering capabilities to improve your antibody sequences.
Some antibody drugs that have progressed into CMC or clinical stages encounter problems with non-specific binding or self-interaction. These issues often result in side effects such as immunogenicity and reduced drug efficacy, leading to substantial economic losses. In vitro developability assays should be conducted before costly in vivo animal study to reduce those developability risk.
Manufacturability assessment is one of the most important evaluation in the development of biologics, which is bridging the drug discovery and CMC. The benefits of manufacturability assessment include:
Report:
Developability assessment help to identify the potential developability risk and help to select the CMC candidates. Candidate C was chosen and finally succeed in CMC.