Accelerating Drug Development with Integrated Developability Assessment

Maximizing Success in Biologics Development: Coriolis Pharma’s Developability Assessment Service

In the early stages of biologics drug development, identifying lead candidates with the highest likelihood of success is critical. Coriolis Pharma’s developability assessment service offers a powerful solution—leveraging the latest experimental methods and advanced computational tools to detect key stability risks and define formulation-relevant parameters while requiring minimal physical material.

This approach enables the early identification of potential liabilities such as colloidal or conformational instability, aggregation, high viscosity, and risk of chemical degradation via pathways like oxidation and deamidation. By addressing these challenges upfront, development teams can make informed decisions that reduce downstream risk and streamline progress toward clinical readiness.

A defining strength of Coriolis Pharma’s approach is its integration of multiple computational techniques. Machine learning models excel at predicting stability issues across large datasets, uncovering trends and risk factors that might otherwise go unnoticed. Meanwhile, mechanistic molecular dynamics simulations provide deeper insight into molecular interactions with excipients—highlighting optimal formulation parameters such as pH ranges, effect of ionic strength and selected excipient. Together, these tools create a broad and detailed picture of how a candidate is likely to behave across different formulation conditions.

These computational predictions form the foundation of a comprehensive and reliable stability assessment, which is then expanded and validated using a unique combination of lab-based experimental methods. This integrated strategy supports data-driven decision-making and Quality by Design (QbD) approaches, enables tailored formulation design, and ultimately accelerates development timelines.

By investing in early risk assessment through innovative assays and in silico modeling, Coriolis Pharma helps biopharma partners confidently advance the most promising candidates—faster, smarter, and with greater precision.

Investigate Key Stability Aspects with Coriolis Pharma’s Unique and Innovative Methods

• Chemical Stability: Identify potential liabilities with advanced machine learning tools and molecular descriptors, without the need for lengthy stability studies.
• Conformational Stability: Rank candidates based on range of thermal stability metrics and predict long term storage stability using folding reversibility.
• Colloidal Stability: Multiparameter in vitro and in silico assessment of colloidal properties provides a detailed understanding of how candidates will behave in formulation development, paving the path to a stable, high concentration product.
• Formulatability: Explore the Formulation Sensitivity of your lead candidates and use Coriolis Pharma’s expertise in the industry to identify the optimal pathway for future development.

4 Weeks from Start to Reporting of Developability Data

Our established, robust mAb platform approach, which is also applicable to other modalities, speeds up phase I clinical trial readiness. Developability assessment at Coriolis takes approximately 4 weeks—from project planning and execution to data reporting. With integrated pre-formulation screening and full lifecycle support focused on the end goal, the transition from molecule to formulation is achieved in just 10 weeks with Coriolis’ team of experts.

When integrating Coriolis high-throughput pre-formulation screening, the transition from a list of potential candidates to one final lead candidate in a stabilizing formulation can be achieved in just 10 weeks. After that, Coriolis Pharma can provide full lifecycle support until commercialization and beyond – always with a focus on the final indication, application route and ultimately the patient benefit.

We offer different options based on your stage of development and development focus. Contact us today to start a developability assessment of your promising biologic (lead) candidates to streamline your drug product development right from the start.