Cambridge Healthtech Institute’s 6th Annual

Continuous Processing in Biopharm Manufacturing

Closing the Gap from Bench to Clinical Scale

August 24-25, 2020

 

Technology and regulatory gaps continue to challenge the implementation of continuous processing for clinical-scale biomanufacturing, despite advances in single-use technologies, up- and down-stream process optimization and intensification.

CHI’s 6th Annual Continuous Processing in Biopharm Manufacturing invites researchers to discuss the challenges and requirements for transitioning from bench to clinical scale and share their latest pursuit of technologies and approaches to close the gap – including real-time monitoring, process control, process intensification/optimization strategies, process validation and quality considerations. Examples of applications of continuous/intensified processing for new/emerging modalities, vaccines and biosimilars will also be explored.

 

Coverage will include, but is not limited to:

 

  • Challenges and Requirements for Transitioning from Bench/Lab-Scale to Clinical/Manufacturing Scale
  • Applications of Continuous/Intensified Processing for Emerging/Complex Biotherapeutics, Vaccines and Biosimilars
  • Closing the Gap in Continuous Bioprocessing 
    • PAT and Real-time in/on-line analyzers, Real-time release testing, system integration and data analytics
    • Supply chain - ensuring continuous supply of raw materials, including single-use supplies, etc.
    • Modeling and validated scale-down systems
    • Process validation
    • Quality and stability considerations
    • Bridging existing batch to continuous
    • Integrating up- and down-stream continuous/connected/intensified processing
  • Technological Advances in
    • New affinity ligands
    • Continuous media/buffer prep
    • Continuous viral inactivation
    • Chromatography resins with high binding capacity
    • Minimizing buffer and hold tanks

 

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





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