Assessment of Manufacturability and Safety to Reduce Risk


Pharmaceutical companies would spend, on average, several billion dollars for every new therapeutic protein that is eventually commercialized. The underlying reason 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. Unsatisfactory physical and chemical properties of drug molecules, such as poor solubility, low stability, high viscosity, the propensity of aggregation, and undesirable post-transcriptional modifications, can impact efficacy and even generate immunotoxic reactions, thus finally leading to failure of the project during late-stage development or clinical trials. With full understanding of this, Protagen Protein Services (PPS) provides comprehensive and state-of-the-art developability assessment service for your biopharmaceutical candidates, in order to address the issues that may lead to potential clinical failure.

Why is developability assessment necessary?

For the reasons mentioned above, the direct transition of molecules selected during early discovery stage with suboptimal properties to late-stage development may increase failures or require expensive and time-consuming formulation and development efforts. 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.

What developability assessment concerns about?

Developability assessment can be considered as the extension of the QbD (quality by design) guidance, providing a bridge between product knowledge and process understanding. It 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, 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.

Developability Assessment Service by PPS

PPS offers comprehensive and state-of-the-art developability assessment services for your drug candidates, in order to address the issues that may lead to potential clinical failure. Through the assessment, the most promising candidate is screened out or engineered to fulfill the manufacturing, formulation, and safety characteristics before further moved to the expensive development process. Our approach consists of mainly three modules: a preliminary screening stage and a comprehensive assessment stage. According to the magnitude of your drug candidates to be evaluated, one or both of the service modules could be chosen to guide your choice of lead candidate for further process development.

  • Initial method development or molecule specific adjustment of existing platform methods
  • Initial molecule stressing to determine early degradation behavior
  • Evaluation of different lead candidates & support of final candidate assessment

Your Contact

please call us +49 (0) 231 9742 6100

Martin Blüggel

Chief Executive Officer (CEO)