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Continuous Manufacturing for the Modernization of Pharmaceutical Production Proceedings of a Workshop (2019) / Chapter Skim
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Appendix C: Running Themes Across Workshop Sessions
Pages 58-60

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From page 58...
... Q13 guideline. Real-time Product Merck Doug Merck's experience: measure Release and Adaptive Richardson CQA; model Process; apply Process Control; appropriate control strategy; Process Analytical use lessons learned to optimize Technology process; and remember that there is "no path to real-time release without process analytical." Viral Safety Guideline Just Lisa Robust and effective viral ICH Q5A Biotherapeutics Connelly- clearance of retrovirus-like Crowley particles is critical.
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From page 59...
... Intensified perfusion platform yields 100  increase in productivity. Continuous MedImmune Lindsay MedImmune has operated downstream processing Arnold continuous downstream with continuous processing for two weeks: Protein upstream processing A capture, low pH virus demonstrated inactivation, filter train, multi column chromatography, single pass buffer exchange, and final concentration has been run with continuous upstream.
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From page 60...
... TABLE C-4 Discussion of Business Case in Technical Sessions Topic Organization Speaker Technologies/Issues Addressed Downstream processing MedImmune Lindsay Arnold The business cases vary based on the particular set of drivers that are important to the company, such as safety, cash flow, capital reduction, space constraints, and capital improvement, and will vary between clinical and commercial settings. Using digital GE Healthcare William Whitford Digital biomanufacturing should biomanufacturing to also support business continuity support product with incident control, manufacturing management, and reporting capabilities, and in-line or on-line, real-time, orthogonal process monitoring and adaptive control.
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Key Terms

  • unit operations
  • downstream processing
  • process analytical
  • critical quality
  • addressed downstream

  • addressed science
  • veena warikoo
  • continuous downstream
  • continuous manufacturing
  • support continuous

  • continuous processing
  • continuous processes
  • run continuously
  • optimize technology
  • skid mounted

  • filter train
  • sessions topic
  • safety guideline
  • increased productivity
  • fewer unit

  • satashi ontake
  • appropriate control
  • processing medimmune
  • pass buffer
  • ontake note

  • downstream unit
  • suspension cho
  • means integration
  • intensification challenges
  • column cycles


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