Developability Assessment
Biologics Developability and Stability Assessment
At Pharmaron, our Developability Assessment services ensure the success of biological drug candidates by providing comprehensive profiling and stability testing. From early-stage candidate selection to formulation assessment, we deliver critical insights into your biologics’ physicochemical properties, scalability, and stability, helping you avoid costly setbacks in clinical development.
Our holistic approach goes beyond standard testing, focusing on identifying potential risks early and ensuring compatibility with manufacturing and regulatory requirements. By leveraging advanced analytical techniques and expertise, we help streamline your biologic candidate’s path from discovery to commercialization.
Capabilities
Developability Assessment for Biologics
Biologics are complex molecules with unique stability, scalability, and formulation challenges. Identifying potential issues early in development—such as degradation, aggregation, or formulation incompatibilities—can save valuable time and resources.
Our developability assessment enables our partners to:
- Select the best drug candidates based on early stability indicators
- Assess molecule integrity and identify risks such as degradation and aggregation
- Determine the platform process fit and formulation suitability for large-scale manufacturing
Comprehensive Developability Services
Our Developability Assessment includes a range of services tailored to biologics, ensuring your drug candidate is optimized for stability, scalability, and successful clinical outcomes:
- Stability study: Assess the stability and potential degradation pathway under different stress conditions, such as thermal, mechanical, or photo-stress
- Physicochemical Property Assessment: Includes key measurements like melting temperature (Tm), solubility, interaction parameter (kD), and hydrophobicity
- Upstream Cell Culture Process Fit: Optimization of the expression system for consistent cell growth and expression levels
- Downstream Purification Process Fit: Ensures viral and viral inactivation compatibility with downstream processes
Ready to Ensure Your Biologics are Prepared for Large-Scale Success?
Contact Pharmaron today for a consultation, and let us help you optimize your development process from early candidate selection through stability studies.
