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



For sponsorship information, please contact:


Companies A-K

Phillip Zakim-Yacouby

Senior Business Development Manager

Cambridge Healthtech Institute

Phone: (1+) 781-247-1815



Companies L-Z

Aimee Croke

Business Development Manager

Cambridge Healthtech Institute

Phone: (1+) 781-292-0777