Developability / manufacturability
An early understanding of what matters most
At Coriolis Pharma we offer the service to screen candidate protein molecules in very early development to assist lead candidate selection with respect to manufacturability and developability, and thereby help to reduce development risks, time and costs.
By utilizing cutting-edge analytical techniques, we aim to generate a basic understanding about which of the candidate molecules from the discovery phase are most robust against stress conditions relevant to production, formulation and storage.
We understand that material in early stages is precious and limited. Therefore, we set up developability studies to gain as much information as possible at a minimum material consumption.
The service for our customers includes:
- Comparative physico-chemical characterization of candidate molecules with respect to critical properties, such as melting temperature (Tm), structural stability and aggregation propensity
- Determination of the colloidal and conformational stability of candidate molecules under selected conditions (e.g., pH, ionic strength)
- Ranking of the relative stability of selected candidates to relevant stress conditions, e.g., elevated temperatures, freeze-thawing, mechanical stress
- Feasibility to evaluate if a liquid, frozen liquid or lyophilized formulation is the way to go and to identify suitable storage conditions for subsequent accelerated stability studies
- Minimum to maximum concentrations to work with
- Impact of process steps like filtration
Get in contact with our experts today and find out how your project can benefit from a developability / manufacturability assessment.