Developability Assessment

From discovery to eventually marketing, pharmaceutical companies would spend a huge sum of money for a new therapeutic drug development. One of the underlying reasons for this huge cost is the exceptionally high rate of failure observed in the development process. Approximately 90% of drug candidates failed during clinical trials because of unsatisfactory physical and chemical properties of drug molecules, intolerable toxicity and low efficacy. The direct transition of molecules selected during early discovery stage with suboptimal properties to late-stage development may require expensive and time-consuming formulation and development efforts. The failure rate of the therapeutic drug could be reduced by "developability" at an early stage.

Developability assessment implements comprehensive investigation to assess manufacturing feasibility (productivity, stability, aggregation, etc.), formability for a specific administration route, and compatibility with in vivo environment, such as immunogenicity, off-target effect, and half-life. In short, it is used to analyze whether the biological lead compound can be successfully developed into an effective therapy. Developability assessment helps to streamline the potency, safety and manufacturability and can screen out the developable candidates that are very effective, low toxic and can reach the preclinical and clinical use.

Developability assessment is a kind of risk assessment, through which the best drug candidate can be selected or, if necessary, risk-mitigated to fulfill the manufacturing, formulation, and safety characteristics before expensive development efforts are initiated. Therefore, the implementation of a knowledge-based developability assessment and experimental screening of drug candidates to select the developable molecules as early as possible is of crucial importance, as opposed to fixing “badly behaved” molecules in the late-stage development. Developability assessment campaign could de-risk the late-stage failures, with the consequent reduction in attrition rates, lowering development costs and shortening the timeline of the development cycle.

With full understanding of the necessity and importance of developability assessment, Creative Biolabs provides comprehensive and state-of-the-art CreDA™ developability assessment service for lead validation of drug discovery process, thus to deal with data reproducibility crisis which is a big obstacle for drug research and development and may lead to failure and high risk of investment. We can drive forward and speed up your drug discovery process by addressing the issues of lead compound that may lead to potential clinical failure.

Figure.1 CreDA™ Platform for Biologics Developability Assessment.

Creative Biolabs offers comprehensive developability assessment based on our CreDA™ platform, which mainly consists of two modules: a preliminary screening stage and a comprehensive assessment stage.

Preliminary Screening

To assess the developability of a large number of candidates, a high-throughput preliminary selection strategy, combine in silico prediction and in vitro assay of the isoelectric point, potential post-transcriptional modifications (PTMs), expression titer, aggregation, and stability, etc., is performed to screen out the top ones (usually <10) that will be ultimately characterized in detail during the comprehensive assessment stage.

Comprehensive Assessment

Comprehensive assessment covers the comprehensive and detailed evaluation of the drug candidates, addressing the developability of each candidate from three different but interactive aspects: 1) manufacturability assessment offers the opportunity to evaluate the technical viability of a drug candidate at the industrial scale and functions as a bridge between discovery and process development stage; 2) immunogenicity assessment aims to evaluate your candidates and guide your choice of the lead molecule with low immunogenicity risk for further process development; 3) in vivo fitness assessment aims to get a preliminary and comprehensive understanding of the behavior of drug candidates in vivo.

Creative Biolabs has a dedicated assay development team that will work closely with you to design customized assays. Our service will meet your specific needs fast at extremely competitive prices. If you need more information, please feel free to contact us at anytime. We look forward to working with you to help your drug research and development project succeed.