Cambridge Healthtech Institute’s 6th Annual

Process Characterization and Control

A Best Practices Forum for the Translation of Process Understanding into Control Strategies for Maintaining Quality Throughout the Product Lifecycle

August 27-28, 2020


The demonstration of process understanding, identification of critical quality attributes and the implementation of well-validated control strategies is now a routine part of biologics manufacturing operations. But significant ambiguities remain in the specific steps that must be taken in the production of legacy and new products, by companies of different scale and resources and for specific product formats. Process Characterization and Control offers a forum for the sharing of strategies and best practices from a wide range of industry companies working to implement these standards for complex new drug products. Proposed presentations should offer case studies of strategies, best practices and technology solutions, and share the rationale behind decisions associated with risk management and resource allocations related to process characterization, qualification and control.  


Coverage will include, but is not limited to:


  • Process Characterization
    • MAM (multi-attribute methods) in process characterization
    • Process characterization for drug product manufacturing
    • Specification setting with a reduced number of clinically qualified batches
  • Process Monitoring and Control
    • Process characterization and control for continuous bioprocessing
    • Risk assessment for process monitoring initiatives; nice to know v. need to have
    • Scale up of process monitoring and control systems
  • Adopting and Implementing PAT
    • Feedback loops and multivariate modeling to improve processes and product quality
    • New sensors and monitoring technologies
    • PAT support for continuous processing
  • Informatics and Big Data
    • Applying prior knowledge for process characterization and justifying specifications
    • Predictive modeling of quality attributes
    • Process simulations using digital twins
  • Regulatory and Standards Issues
    • Handling of NOR (Normal Operating Ranges) in regulatory filings
    • New ICH guidelines and regulatory guidances
    • Process characterization for breakthrough designations and new modalities
  • Challenges
    • Managing the impact of process intensification on quality systems
    • Transitions and transfers for quality systems
    • Will advanced process controls enable reduced release testing?


* The program is subject to change without notice, due to unforeseen reason.

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