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"Safeguard Your mAb Pipeline with Early Stability Testing"

Catalent's orthogonal stability studies de-risk monoclonal antibody programs through forced degradation testing and formulation optimization.

Stability studies are crucial for monoclonal antibody (mAb) development. Without proper characterization, your therapeutic could face regulatory delays, reduced shelf life, or termination. Changes during purification, formulation, and distribution can affect protein stability, compromising safety and efficacy. Conducting comprehensive stability studies internally requires specialized equipment and expertise that many organizations lack.

This case study shows how Catalent's experts helped a biologic developer conduct essential stability studies quickly. The analysis provided insights into their IgG1 mAb's vulnerabilities, informing formulation decisions and strengthening regulatory submissions. Discover how the right analytical partner can transform your stability testing strategy with takeaways like:

• A multi-method approach identified critical degradation pathways missed by a single method
• Thermal and acidic conditions posed the greatest challenges
• Techniques revealed subtle yet significant changes

Offered Free by: BioPharma Dive's studioID and Catalent
See All Resources from: BioPharma Dive's studioID and Catalent