Cambridge Healthtech Institute’s 11th Annual

Analytical Characterisation of Biotherapeutics

Expanding Analytical Toolkit for New Modalities

6 November 2024

The Analytical Characterisation of Biotherapeutics conference addresses the critical challenges and opportunities arising from the surge in novel therapeutic modalities. Companies are trying to adapt analytical platforms originally designed for mAbs to the complexities of multispecifics, ADCs, smaller protein formats, viral vectors and nucleic acid delivery systems. We invite speakers to present methods to assess critical quality attributes of these new modalities, determine higher order structures and physico-chemical characteristics, and discuss ways they are using computational tools, machine learning, and AI to streamline and accelerate the characterisation process.

Coverage will include, but is not limited to:

  • Transitioning your analytical platform from mAb to novel modalities
    • Adapting existing assays and workflows for newer modalities
    • Understanding CQAs specific to novel modalities and defining acceptance criteria
    • Tailoring characterisation strategies and developing methods to assess new modalities
    • Case studies on successful platform transitions
  • Characterisation of Novel Antibody-Derived Formats
    • Bispecifics and multispecifics—understanding and controlling higher-order structures, multiple binding domains, target engagement and potential for aggregation,
    • Antibody-drug conjugates—analysing drug load, distribution, linker stability
    • Single domain antibodies, nanobodies, bicycles, peptides—biophysical characterisation techniques tailored to smaller formats
  • Analytics for Genetic Medicines
    • Viral Vector characterisation—purity, potency, capsid integrity and potential for HCP
    • Nucleic acid delivery system—LNP size, mRNA sequence, characterisation of novel excipients and delivery components
  • Data Integration in Analytical Characterisation
    • Handling large and diverse datasets from multiple analytical techniques
    • Data management and ensuring data integrity across different systems
    • Collaboration between experimental and computational scientists for efficient data analysis
    • Using machine learning and AI to streamline and accelerate analytical characterisation
    • Developing automated data analysis tools and workflow

The deadline for priority consideration is 29 March 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:

For more details on the conference, please contact:

Mimi Langley
Senior Conference Director
Cambridge Healthtech Institute
Phone: (+1) 781-972-5439

For sponsorship information, please contact:

Companies A-K
Jason Gerardi
Sr. Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-5452

Companies L-Z
Ashley Parsons
Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-1340