Cambridge Healthtech Institute’s 12th Annual
Protein Stability & Formulation
Improving Efficacy and Mitigating Immunogenicity Risks
13 November 2025
Cambridge Healthtech Institute’s 12th Annual Protein Stability & Formulation conference examines advanced approaches for enhancing biotherapeutic stability and formulation-fit. Sessions highlight AI/ML applications for stability prediction across modalities, cutting-edge particle-analysis techniques and their immunogenicity implications, Bayesian approaches for formulation optimisation, and innovative delivery solutions for next-generation biologics. The conference shares creative approaches to overcome challenges in the development of stable, safe, and efficacious biologics.
Coverage will include, but is not limited to:
Challenges and New Approaches for Stability Prediction of New Therapeutic Modalities
- Advanced techniques for thermal and colloidal stability
- Predictive models for chemical and physical stability
- Stability considerations for multispecifics, ADCs, and nanobodies
- Drug product stabilitiy studies: kinetic modeling to predict long-term stability
- AI tools for multational hot spot prediction to improve protein conformation and colloidal stability
- Prediction of chemical degration
- Polysorbate degradation and how it affects drug product
New Techniques for Particle Analysis and Immunogenicity Assessment
- Dynamic light scattering for virus particles and micelles
- AI-based approaches for particle image analysis
- Liquid-liquid phase separation and particle formation
- Relationship between particle morphology and immunogenicity
- Advanced techniques for particle differentiation
- Predictive immunological cellular assays to address immunogenicity and impurities
Formulation Strategies and Delivery Considerations for Next Generation Biologics
- In silico and AI-driven formulation strategies
- Digital tools for HTP formuation screening and development
- in silico modeling for excipient selection and aggregate control
- Bayesian optimisation for formulation design
- Microfluidic droplet platforms for formulation development
- Formulating high concentration protein therapeutics
- Challenges in developing sustained relase injectible biologics
- Oral delivery formulation for autoimmune diseases
- Subcutaneous delivery challenges
- Co-formulation strategies
The deadline for priority consideration is 28 March 2025.
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: