Cambridge Healthtech Institute’s 5th 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 15-16, 2019

With the recent publication of process validation guidances from both US and European regulators, the demonstration of process understanding, identification of critical quality attributes and the implementation of well-validated control strategies must now become 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 complex new standards.

Proposed presentations should offer case studies of strategies, best practices and technology solutions – and sharing of 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:

Regulatory Issues in Bioprocess Quality Systems

  • Comparing the standards of FDA, EMA and ICH
  • Impact of ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) on quality systems
  • Regulatory trends in process validation and equipment/facility qualification
  • Update on BPOG roadmap for in-line monitoring and real time release

Overcoming Big Data Challenges in Process Characterization and Control

  • Case examples of applying modeling for analysis process variables and quality attributes
  • Company best practices for the collection and standardization of bioprocessing quality data (sample and study metadata, instrument level data)
  • Transitioning from benchtop analysis (Excel, traditional modeling tools) to AI and machine learning
  • Update on initiatives to promote data standards and integration (Allotrope Integration Project, Pistoia Alliance)

Best Practices for Process Characterization

  • Do high throughput and rapid technologies have a place in process characterization?
  • Multivariate analysis using qualified models for process characterization
  • Phase appropriate process optimization and characterization
  • Process characterization for cell and gene therapies (and contrast with protein therapeutics)

Emerging Technologies for Process Monitoring

  • Artificial intelligence applications in process control; is a “transparent box” better than a “black box”?
  • Microfluidic and nanofluidic tools for monitoring and analysis in continuous bioprocessing
  • Plant layout considerations – “quick check” analytical  
  • Resolving challenge areas in process monitoring (fold/percentage of fold, inline detection of host cell proteins, glycosylation quality)

Moving to Real Time Product Release

  • Technology progress and bottlenecks in PAT tools for continuous processing
  • Strategies for inline and online monitoring of unique protein structures
  • Control strategies – what to test at each step and why
  • Regulatory and technology trends in lot release testing

If you would like to submit a proposal to give a presentation at this meeting, please click here.

The deadline for priority consideration is February 11, 2019.

All proposals are subject to review by session chairmen and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute 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.

For more details on the conference, please contact:
Kent Simmons
Senior Conference Director
Cambridge Healthtech Institute
Phone: 207-869-9199

For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-1359  

Companies L-Z
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5412