Developability Assessment

Assess manufacturability and immunogenicity to reduce candidate risk

Our developability toolbox is a suite of in silico and in vitro tools and expertise:

• Our manufacturability assessment service analyzes chemical degradation pathways, post translational modifications including deamidation, oxidation and glycosylation, and potential physicalstability issues, most notably, protein aggregation.
• Our immunogenicity assessment service uses our proprietary Epibase® in silico and in vitro screening tools to identify T cell epitopes that may trigger potential immune reactions.

These services are applicable for all protein types whether derived from mammalian or microbial expression systems.

The benefits of early risk assessment include:

• Reduction in development costs and time
• Acceleration of the lead candidate selection process
• Increased the chance of a candidates success
• Potential optimization of the process before problems arise in development
• Improved chance of successful manufacturing scale-up

The post assessment deliverables include full reports highlighting the predictions and analyses from the services listed above. If high-risk issues are identified in the initial assessment, our experts have an extensive range of protein engineering capabilities that have the potential to improve the structure, biological activity and the manufacturing properties of your drug candidate.

Address predicted risks

We offer risk mitigation for both early and later-stage development programs. Early-stage mitigation strategies include proprietary in silico and in vitro screening and re-engineering while later stage programs address issues through process development optimization.

Following a complete Developability Assessment, customers will be provided with a full report outlining potential issues highlighting those that pose a high risk. The report will include mitigation options for the candidate. Our protein engineers are adept at improving the structure and the manufacturing properties of your drug candidate. In addition, we can manufacture non-GMP and GMP products for in vitro validation of findings, including immunogenicity.