Title: Facility Design for Continuous Bioprocessing and Smart Manufacturing: Attributes for Success

Jeff Odum, CPIP Setting the Stage In testimony given 2013 during a congressional modernization hearing, FDA Director Janet Woodcock clearly outlined the regulatory impetus for the industry’s continued drive to implement continuous manufacturing platforms.1 She challenged the biomanufacturing organizations to take advantage of advances in process and facility design to help achieve improved manufacturing reliability, increased process robustness, and lowering of manufacturing costs. Move forward to 2017 when CDER finalized the guidance, “Advancement of Emerging Technology, Applications for Pharmaceutical Innovation and Modernization"2 Again, the driving focus of regulatory policy is to promote technology that can produce a more robust manufacturing process with fewer interruptions in production and ensure that facility assets can support these advanced platforms. Yet continuous biomanufacturing is not a recent phenomenon. Perfusion-based bioreactor operations have been in use for over 25 years. The focus use was on high-value and labile proteins from low yield expression systems. These systems had many production and regulatory challenges. But with new platform technologies, advanced equipment designs, and advances in automation/control systems, continuous manufacturing is rapidly gaining acceptance across a wider spectrum of manufacturing operations. Traditional State vs. Future State

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   Person Information
   Application Sequencing
 325412 - Pharmaceutical Preparation Manufacturing                
Company  Product  Process  Other  Subjects  Event  Event  Date  Location  Publication  Publication  Date Text  Descriptor
  • Facility

  • Continuous Manufacturing

  • Design

  • Engineering






  • American Pharmaceutical Review


  • 1/1/2019


  • Article