Pre-Conference Workshops* 

June 12, 2012

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

Instructor: 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

3:30-6:30pm 

Instructors:
Nicholas Leadbeater, Ph.D., Associate Professor, Chemistry, University of Connecticut
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Bryan Li, Ph.D., Associate Research Fellow, Chemical R&D, Pfizer Pharmaceutical Science
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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