Cambridge Healthtech Institute’s 10th Annual

Accelerating Analytical Development

Optimizing the Speed and Efficiency of Key Analytical Steps in Biotherapeutic Development

August 16-17, 2023

Industry analytical groups are facing increased pressure to deliver key studies faster than ever before – and at lower costs. Cambridge Healthtech Institute’s 10th Annual Accelerating Analytical Development conference offers a best practices forum in which industry scientists and managers can exchange ideas on strategies, new technologies, and the integration of analytical methods in support of these goals. The conference will address the most important roles of the analytical function from early development through release testing and provide insights on how different organizations are addressing these challenges.

Coverage will include, but is not limited to:

Platforms & Workflows for Novel Modalities

Combination products and co-formulations
Handling of novel molecules and modalities without existing platforms
Overcoming the analytical bottlenecks of AAVs (low sample volumes, potency assays, empty/full capsids, platformability, risk assessment, accelerated timelines for rare diseases)

Product Quality & In-Process Controls

Control strategies for novel molecules and modalities; implementing analytical QBD
Increasing the application of MAM in QC
New methods and instruments for PAT and in-process analytics

Automation & Miniaturization

Best process for automation workflows
Increasing throughput for process development analytical studies
Miniaturization of assays and sample requirements

Digital Initiatives to Accelerate Analytical Development

Data automation
Data collection issues: quality, storage, instrument integration, accessibility, application of prior knowledge
Implementing ML and modeling applications in analytical development

Implementation Considerations for ICH Q14

Impact on regulatory dialogs and filings
Lifecycle management of analytical methods
Target analytical profiles for therapeutic proteins and cell/gene therapies

Emerging Methods and Instruments

Automated image analysis
Expanding the roles of MS
Structure/function studies in analytical development

The deadline for priority consideration is February 3, 2023.

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: