Cambridge Healthtech Institute’s 15th Annual
Methods for Developability Analysis
Platforms and Approaches for Assessing Quality of Biotherapeutic Molecules and Selecting Developable Lead Candidates
January 14-15, 2025
This conference will delve into the latest advancements and emerging strategies for analyzing and characterizing aggregation, stability, and immunogenicity in biologic drug development. Cambridge Healthtech Institute's 15th Annual Methods for Developability Analysis track will cover a comprehensive range of topics, from uncovering fundamental mechanisms to applying state-of-the-art analytical techniques and control strategies. Attendees will gain insights into the complex interplay between aggregation, chemical stability, and other physical stability aspects, such as conformation, colloidal stability, and interfacial behavior. The program will also explore potential origins of immunogenicity in biotherapeutics development and downstream implications. Advanced analytical methods for assessing these critical quality attributes will be highlighted and discussed with respect to leveraging analytical insights towards proactively developing more stable and effective biologic drug formulations.
Coverage will include, but is not limited to:
- Advanced and emerging technology platforms for detecting and characterizing aggregates and impurities
- Automated systems for integrating analytical pipelines and increasing throughput
- Lead molecule engineering to circumvent issues with developability
- Novel formulation strategies and excipients to control aggregation, chemical degradation, and physical instability
- Recent progress in bioassays for immunogenicity risk assessment
- Regulatory perspectives on best practices for addressing aggregation and stability challenges during development and manufacturing
- Selection and application of analytical methods based on constraints associated with development phase
The deadline for priority consideration is June 28, 2024.
All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
Opportunities for Participation: