06.13.24 -- Leveraging Immunogenicity Assays To De-Risk & Improve Biologic Development

Developability bridges the gap between the ideal and the real by focusing on two fundamental factors: manufacturability and functionality. By prioritizing developability early in development, researchers can proactively identify and manage potential roadblocks. Review the developability steps to success and explore how both pre-defined and tailored work packages can best fit your project needs.

Integrating immunogenicity risk assessment into lead candidate selection prior to clinical trials minimizes development risks and strengthens IND applications. Review the performance of a novel flow cytometry-based assay that can enable a more comprehensive understanding of immunogenicity risk and learn how immunogenicity testing can help to de-risk drug development.

Immunogenicity is a critical factor in the development of therapeutic proteins, as it can impact both their effectiveness and safety. Through a deeper understanding of immunogenicity, researchers can harness the full potential of advanced therapies, paving the way for a future of safer and more effective treatments for diseases.

The promise of protein therapeutics is often hampered by unforeseen immune reactions. Assessing a drug's immunogenic potential early in development is critical for success. Review a platform that leverages a data-rich approach to provide a deeper understanding of immunogenicity risk, ultimately leading to safer and more effective treatments for patients.

Therapeutic protein immunogenicity poses a significant challenge in development and patient safety. Assessing this risk early is crucial. While more complex and resource-intensive, explore how MAPPS demonstrates promise as a valuable tool for comprehensive immunogenicity assessment in therapeutic protein development, contributing to safer and more effective biologics.