Cambridge Healthtech Institute’s 13th Annual
Analytical Characterisation of Biotherapeutics
Harnessing Advanced Analytics to Speed Development
18 November 2026
The Analytical Characterisation of Biotherapeutics conference delves into state-of-the-art methods to characterise complex biologics from intact proteins to advanced modalities. Attendees will explore native and ion mobility MS, MAM, and single-particle tools alongside strategies for multispecifics, ADCs, radiopharmaceuticals, gene and RNA therapeutics. The program also addresses functional bioassays, MOA-relevant potency testing, and digital and AI-enabled data integration to support quality, comparability, and regulatory expectations.
Coverage will include, but is not limited to:
CHARACTERISATION OF COMPLEX MODALITIES: MULTISPECIFICS AND CONJUGATES
- ADC-DAR measurement by HIC, RPLC and native MS
- Multispecific antibodies—chain pairing verification, assembly confirmation, unwanted species identification
- Next-generation conjugates—dual payload ADC, bispecific ADCs, antibody-oligonucleotide conjugates (AOC), degrader-antibody conjugates, antibody-radioligand conjugates
- Glycan and glycoform analysis for complex biotherapeutics—glycopeptide MS, glycan mapping, glycosylation characterisastion
ANALYTICAL STRATEGIES FOR EMERGING MODALITIES
- Analytical strategies and CQA for gene editing tools, RNA/siRNA, LNP delivery and viral vectors
- Viral vectors for gene therapy—full/empty capsid ratio, genome integrity and potency assays
- LNPs for mRNA therapeutics—particle size and PDI, epcapsulation efficiency, RNA integrity
- Oligonucleotide and siRNA therapeutics—sequence conformation, impurity profiling stability indicating methods
- Targeted radiopharmaceuticals: radiochemical purity, radiolabeling efficiency, in vitro stability
ADVANCED MASS SPECTROMETRY: FROM INTACT PROTEINS TO SINGLE PARTICLES
- Native MS for glycoforms, charge variants, and DAR ratio distribution
- Top-down and middle-down MS for sequence variant detection and PTM mapping
- Ion mobility MS (IM-MS) for conformational charcterisation
- HDX-MS for higher order structure and comparability
- Combining MS with ELISA, biophysical tools for PKPD and potency
- Single particle and single molecule MS platforms for characterizing LNPs, viral vectors
- MAM and high throughput MS for attribute monitoring
FUNCTIONAL BIOASSAYS AND MOA CHARACTERISATION
- Cell-based vs. cell-free potency assays for novel biotherapeutic formats
- Designing MOA-relevant bioassays—understanding structure-function relationships
- Imaging-based bioassays and high content analysis for ADCs and immune-cell tracking
- Potency and CQA strategies for cell therapies and in vivo cell engineering approaches
DIGITALISATION AND DATA SCIENCE INTEGRATION IN ANALYTICAL DEVELOPMENT
- AI-enabled data interpretation for MS, imaging, and biophysical datasets
- Data integration frameworks linking modeling and experiments for biophysical liability prediction
- Lab-in-a-loop for method development and DoE
- Lab automation
The deadline for priority consideration is 9 April 2026.
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: