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