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:

 

 

For more details on the conference, please contact:

Kent Simmons

Senior Conference Director

Cambridge Healthtech Institute

Phone: (+1) 207-329-2964

Email: ksimmons@healthtech.com

 

For sponsorship information, please contact:

Companies A-M

Phillip Zakim-Yacouby

Senior Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-247-1815

Email: philzy@cambridgeinnovationinstitute.com

 

Companies N-Z

Aimee Croke

Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-292-0777

Email: acroke@cambridgeinnovationinstitute.com