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FDA-AIChE Workshop on Adopting Continuous Manufacturing

Overcoming the Perceived Obstacles
February 29 - March 2, 2016

This two day workshop, conceived and chaired by Dr. Paul Collins of Eli Lilly, aims to address barriers to adoption of continuous processing in the Pharmaceutical Industry. Leading practitioners will highlight continuous production experience to date, including work towards regulatory filing. Structured focus group discussions will help define, clarify and discuss mitigation of barriers to adoption.


Proceedings of the FDA-AIChE Workshop on Adopting Continuous Manufacturing are now available:

The Opportunity

Continuous processing has the potential to make the production of pharmaceuticals more responsive to patient needs.  This workshop will address regulatory and other challenges associated with the implementation of this technology in pharmaceutical development and manufacturing.  New technology conception to full incorporation has often required 20 + years.  In some instances, uptake of technologies is never fully realized.  Continuous manufacturing is the latest “initiative” that has met resistance to full-scale implementation despite the fact that many pharma companies used continuous manufacturing in the 1970’s and 1980’s for large-volume antibiotic and animal health products.

The Approach

This workshop addresses the issues surrounding full adoption of continuous manufacturing in pharmaceutical processing.   Business cases for successful implementation will be shared, and focus groups will discuss these cases while addressing the top perceived issues.  Technical sessions demonstrating the process and quality control benefits of implemented continuous manufacturing will be shared.  The output of the workshop is targeted to inform ongoing regulatory guidance writing efforts.

Who Should Attend

From Pharma companies:

  • VPs of Chemical Development, CMC, Regulatory, Quality and Global Supply
  • Senior Directors and Managers whose teams are applying or considering continuous processing
  • Technical specialists and technology developers in CM/ flow chemistry 

Strategic partners in the pharma development and supply networks

  • CMOs
  • CROs
  • Equipment, instrumentation and software suppliers

Regulators concerned with development or application of regulatory guidance

  • Directors
  • Reviewers
  • Inspectors

Program Committee

Program Chair

  • Paul Collins, Lilly


  • Christine Moore, FDA
  • Thomas O'Connor, FDA
  • Bernhardt Trout, MIT
  • Chris Seymour, Pfizer
  • Mike O'Brien, Pfizer
  • Andy Scott, GSK
  • John Lepore, Merck
  • Andrew Buswell, GSK
  • Joe Hannon, Scale-Up Systems
  • Gintaras Reklaitis, Purdue University