Cambridge Healthtech Institute’s 12th Annual
Accelerating Analytical Development
Applying New Technologies to Optimize the Speed and Efficiency of Biotherapeutic Development
August 18-19, 2025
The 2025 Accelerating Analytical Development conference focuses on advancing the efficiency and precision of analytical workflows to support the rapid progress of biotherapeutics. The program emphasizes the role of automation and multiplexing in streamlining assay processes and improving reproducibility, while also addressing the challenges of transitioning between development phases and across sites. Attendees will gain insights into predictive modeling techniques that leverage historical data to optimize stability assessments and candidate selection. Topics also include strategies for overcoming common troubleshooting challenges, such as reagent variability and sample prep bottlenecks, and the transformative impact of digitalization and AI tools in data integration and analysis.
Coverage will include, but is not limited to:
Automation and Multiplexing
- Assuring comparability in moving an assay from manual to automated
- Automation of at-line process analytics
- Best practices developing miniaturized assays
- Next-generation multiplexed instruments
Optimizing Transitions
- Best practices for phase-appropriate analytics (preclinical, P2, P3, commercial/PPQ)
- Optimizing transfers—interphase, sites, development to QC/GMP, to/from CDMO
- Risk assessment in planning analytical timelines
Predictive Methods and Models
- Development and application of mechanistic models based on historical data
- Predictive models for stability and biophysical attributes
- Regulatory acceptance of predictive models vs. long-term stability studies
- Using predictive models to triage candidates
Troubleshooting in Analytical Development
- Developability stage fit-for-platform analyses
- Justification of specification (bioassays, biophysical, compendial, biochemical, cell-based)
- Managing reagent variability
- Methods that don’t validate properly
- Protein or solution conditions that impact assay performance
- Resolving sample prep bottlenecks
Use Cases of Digitalization and ML/AI in Analytical Development
- Automating data capture
- Best practices for working with historical data
- Case studies of desktop data dashboards and software (ELNs, proprietary LLMs, models)
- Company-wide digitization initiatives; data lakes, FAIR principals, integrated analysis
- Training data development for specific applications
The deadline for priority consideration is January 27, 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: