Cambridge Healthtech Institute’s 16th Annual
Characterization for Novel Biotherapeutics
Analytical Best Practices for Emerging Modalities
May 14-15, 2026
Rapid innovation in biologics is driving an explosion of new modalities—from genetic medicines and cell therapies to radioconjugates, next-generation antibody–drug conjugates, and oligonucleotide- or peptide-based platforms. Cambridge Healthtech Institute's 16th annual Characterization for Novel Biotherapeutics conference will spotlight the analytical strategies, regulatory expectations, and quality frameworks needed to evaluate these complex products. Sessions will explore potency and release assays for RNA and gene-editing tools, comparability and CQA definition for living cell products, dosimetry and conjugation analytics for radiotherapies, and advances in linker, payload, and scaffold characterization for emerging conjugates. Attendees will gain insight into high-throughput and data-driven methods that accelerate development while addressing manufacturability, scalability, and cost-of-goods challenges. This program offers a comprehensive look at how cutting-edge analytics are enabling the next generation of therapeutics to reach patients safely and efficiently.
Coverage will include, but is not limited to:
Genetic Medicines
- Analytical strategies for emerging modalities: RNA, siRNA, gene-editing tools, LNP-delivery systems
- Assay development for characterization and potency assessment
- Challenges in vector design and characterization for ex vivo and in vivo applications
- Regulatory expectations and quality frameworks for genetic medicines: evolving guidance and lessons learned from early submissions and failures
Cell Therapies
- Analytical and control strategies for in vivo cell engineering approaches
- GMP compliance and comparability challenges for autologous and allogeneic cell therapies
- Impact of analytical complexity on cost of goods (COGS) and scalability in commercial manufacturing
- Specification setting and critical quality attribute (CQA) definition for living cell products
Radiotherapies
- Analytical methods for dosimetry and release testing
- Characterization strategies for radioconjugates and targeted radiopharmaceuticals
- Conjugation platforms and hybrid modalities combining radionuclides with antibodies or peptides
- Regulatory considerations and evolving guidance for biologic-linked radiotherapies
Next Generation Conjugates
- Advances in conjugation chemistries and platforms for emerging conjugations
- Analytical characterization of novel linkers, payloads, and multimodal constructs
- Developability and manufacturability challenges for next-gen conjugates
- Regulatory expectations and control strategies for new conjugate modalities
Oligonucleotide and Peptide Therapeutics
- Advances in characterization for aptamers, siRNA, and antisense platforms
- Analytical and developability considerations for synthetic peptides and peptidomimetics
- Emerging strategies for conjugated oligonucleotides
- High-throughput and data-driven method development for oligonucleotides and peptides
Other Emerging Modalities
- Innovations in antibody formats, including multispecifics and novel scaffolds
- Neuroscience and BBB-crossing therapeutics
- New antibody constructs
- Protein degraders, molecular glues, and other proximity-inducing modalities
The deadline for priority consideration is October 17, 2025.
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: