Cambridge Healthtech Institute’s 5th Annual

Analytics and Characterisation

19-20 March 2024

Cambridge Healthtech Institute’s 5th Annual Analytics and Characterisation meeting discusses methods for ensuring biotherapeutic safety, purity, and potency. Topics include process development optimization, quality control, monitoring, advances in analytical tools and techniques as well as risk assessment and mitigation strategies. We tackle important problems such as understanding the complexity and heterogeneity of biomolecules, managing impurities, and addressing the need for analytical equipment that can keep pace with increasing demands. Here, we convene to enable more comprehensive characterisation and analysis of biotherapeutics.

Coverage will include, but is not limited to:

Process Development Optimisation

Best practices
Data management, analysis, and automation
Integration of continuous manufacturing
Orthogonal testing
Sample preparation and handling

Quality Control and Monitoring

Analyzing and characterizing heterogeneity
Analyzing biomolecular interactions and binding affinities
Assessing and improving product purity
Biosimilars characterisation and analysis
Comparability studies for quality assurance
Developing thorough quantification and protein assays
Higher order structures (HOS) characterisation and analysis
Improving critical quality attribute (CQA) assessments
Structure and function analysis studies

Advances in Analytical Tools and Techniques

Advances in sensitivity and specificity of analytical equipment
High-throughput and automated approaches
Integration of machine learning and modeling
Miniaturization of assays and sample requirements
Multi-attribute monitoring (MAM)
Novel applications of mass spectroscopy and spectroscopic techniques

Risk Assessment and Mitigation Strategies

Detecting, characterizing, and managing impurities, degradants, and aggregates
Extractables and leachables (E&L) testing
Glycoprotein analysis and characterization
ICH Q14 considerations
Identifying and managing immunogenicity

The deadline for priority consideration is Friday 22 September.

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: