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Pre-Conference Workshops* 

June 12, 2012

SC1: Refining API Process Development for This Decade
12:00-3:00 pm

Neal AndersonInstructor: Neal Anderson, Ph.D., President, Anderson’s Process Solutions


Topics to be covered:

Safety considerations to enable process development:

  • Controlling the generation of heat and gases. Examples: Curtius rearrangement, Heck reaction, phase transfer-catalyzed reaction
  • Designing inherently safe processes

Tips to anticipate and avoid scale-up problems:

  • Considering the impact of water and other trace impurities.
  • Side products that can stall or impede reactions
  • Some “war stories” from process introduction

Brief update on controlling genotoxins in APIs:

  • Functional groups identified as creating potential genotoxins (PGIs)
  • Examples to avoid, control, and expel PGIs, including route selection and workup

• • •

SC2: Incorporating Continuous Flow Chemistry


Nicholas LeadbeaterNicholas Leadbeater, Ph.D., Associate Professor, Chemistry, University of Connecticut
Click for Bio 

Byan LiBryan Li, Ph.D., Associate Research Fellow, Chemical R&D, Pfizer Pharmaceutical Science
Click for Bio 

Timothy Braden, Process Chemist, Continuous Chemistry Group, Chemical Product R&D, Eli Lilly and Company

Topics to be covered:

  • Flow Chemistry Basics for Process Chemists
    • Introduction to flow chemistry
    • Advantages and benefits of flow chemistry
    • When is it best NOT to use flow chemistry as a tool
    • When is best to adapt flow chemistry to process?
  • Process Safety for Flow Processes
    • Equipment overview
    • Testing of continuous process streams – special considerations
    • Dealing with equipment failure/'What-if tests' – additional requirements
  • Scaling-Up Flow
    • Equipment considerations when transitioning from:
      • Research lab to Kilo lab
      • Kilo lab to Production facility/pilot plant
    • Regulatory considerations for filing flow processes
  • Panel Discussion
    • Questions from the audience to all the instructors
    • Comparisons of various flow systems (either by discussion or with actual demos if appropriate vendors participate)

*Separate registration required


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