Cambridge Healthtech Institute’s 15th Annual
Characterization for Novel Biotherapeutics
Analytical Best Practices for Emerging Modalities
May 15-16, 2025
The Characterization for Novel Biotherapeutics conference addresses the evolving landscape of biotherapeutic development, emphasizing the analytical challenges and innovations required for new therapeutic modalities. This conference will explore co-formulations, BBB-crossing therapies, and protein degraders, alongside the complexities of genetic medicines and their associated in vivo assays. We will delve into multispecifics, including bispecific ADCs, and address the intricacies of conjugation technologies, both novel and next generation. Topics also include oligonucleotide therapeutics, with a focus on aptamers and conjugated oligos. Additionally, practical issues such as patient delivery device characterization and potency assays for emerging modalities will be discussed.
Coverage will include, but is not limited to:
Emerging Modalities
- Co-formulations and therapeutic cocktails
- Neuroscience and BBB-crossing therapeutics
- Protein degraders
Genetic Medicines
- Case studies of complex genetic modalities: aligning formats with methods
- In vivo assays
- Progress in developing platforms and standards
Multispecifics
- Bispecific ADCs
- Pairing and assembly challenges
- Upstream and downstream process analytics
Next Generation Conjugates
- Developability analysis for novel conjugations
- New conjugation chemistries and platforms
- Regulatory impacts of new conjugations<
Oligonucleotide Therapeutics
- Aptamers
- Conjugated oligonucleotides
- Method selection and emerging methods
Problems and Solutions
- Characterization of patient convenience delivery devices
- Potency assays for novel therapeutic modalities
The deadline for priority consideration is October 11, 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: