DevelopabilityOptimierung

Developability refers to the set of properties that determine whether a candidate therapeutic molecule can progress from discovery to a commercially viable product. It is not a measure of efficacy alone; it focuses on the practical feasibility of development, manufacturing, regulatory approval, and patient access.

In biologics and peptide therapeutics, developability assessments examine stability (thermal, chemical, aggregation), solubility and viscosity at high concentrations, formulation compatibility, post-translational modifications, and sequence liabilities. Biophysical profiling, in silico liabilities screening, and early in vitro assays help flag developability risks before costly optimization. Common risk areas include aggregation under stress, proteolytic susceptibility, non-specific binding, polyreactivity, and immunogenic potential.

Manufacturability considerations cover expression yield, purity, product-related impurities, process robustness, scalability of production, and cost of goods. Pharmacokinetic and safety aspects, such as expected half-life, immunogenicity risk, target specificity, off-target effects, and potential toxicity, influence developability.

The goal of developability assessment is to triage candidates early, prioritize molecules with favorable risk–benefit profiles, and guide engineering strategies to improve properties without compromising activity. It involves multidisciplinary collaboration among medicinal chemistry, protein science, formulation, process development, and regulatory affairs. Developability evaluative frameworks are applied iteratively as candidates advance through preclinical and clinical stages to increase the probability of successful development.