Developability Studies for Biologics and Antibody Lead Candidates
The journey from discovery to commercialization of new biopharmaceutical drugs is always time-consuming and costly. In this respect, it is of utmost importance to determine decisive factors for a successful lead selection such as manufacturability, biophysical properties and pharmacokinetics as quickly as possible to ensure targeted development.
Bridging Product Knowledge and Process Understanding
Our developability assessment spanes a bridge between product knowledge and process understanding, enabling better decisions in:
- Lead and clone selection
- Cell line and upstream process development
- Formulation and drug product development
- Overall CMC and lifecycle strategy
- Downstream process development support
This integrated approach helps you optimize efficacy, safety and overall quality of your biologics at an early stage of development and significantly reduces the risk of later-stage setbacks.
Our vast experience and deep knowledge in this field allows us to guide you through the variety of available methods and help you find the optimal analytical solution for your project.
We adapt our platform methods to the properties of your drug substance, its individual formulation matrix, and your specific analytical question, and qualify them as needed according to ICH guidelines.
Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.
