Dr. Thomas FladHead of Business Development
South Germany, DACH Region
Bringing Discovery and Development together
The path from discovery to commercialization is long and expensive. Unsatisfactory physical and chemical properties of biopharmaceutical candidates could lead to failure of the project during late-stage development or clinical trials.
Developability is an assessment of the suitability of a biological candidate to be successfully developed into an effective therapy. Can the candidate be manufactured, formulated for the appropriate route of administration and provide the desired pharmacology and pharmacodynamic characteristics?
Protagen Protein Services (PPS) provides comprehensive and state-of-the-art developability assessment service for your biopharmaceutical candidates, in order to address potential manufacturing and safety risks at the early stages of the discovery and development processes can build quality into your product, by design.
Why is developability assessment necessary?
Developability helps to reduce the gap by designing or engineering biopharmaceutical candidates to optimize efficacy, safety and quality can promote reduced costs and timelines and increase success rates.
The approach of developability assessment is on:
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.
Our approach consists of two 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.
Also 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.