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:
For more details on the conference, please contact:
Nikki Cerniuk
Conference Producer
Cambridge Healthtech Institute
Phone: (+1) 781-972-1350
Email: ncerniuk@healthtech.com
For sponsorship information, please contact:
Companies A-K
Phillip Zakim-Yacouby
Senior Business Development Manager
Cambridge Healthtech Institute
Phone: (1+) 781-247-1815
Email: pzakim-yacouby@cambridgeinnovationinstitute.com
Companies L-Z
Aimee Croke
Business Development Manager
Cambridge Healthtech Institute
Phone: (1+) 781-292-0777
Email: acroke@cambridgeinnovationinstitute.com