Advancing Process Development: AIChE Division Insights and Future Directions

1. Introducing the…AIChE Process Development Division Bob Duggal Ethyl Corporation

2. Agenda • Background & History • Structure and Current Leadership • Recent Programs & Activities, Future Programs • Benefits to Division Members • How to Get Involved • Q&A, Remarks

3. Effective Process Development • New product or process ideas • Superior process research and innovation • Detailed pilot plant scale-up • Thorough technology transfer • Quality manufacturing leading to successful commercialization and business results

4. Background & History… • Pilot Plants Area 12A started in 1984 within the “Engineering Division” • Forum for pilot plant engineers & managers • Industrial focus with some academic participation • Programmed 1-2 sessions in AIChE National Meetings • Was the most active group within Engineering • In mid-1990’s, scope broadened to other areas • Benchmarking, networking, industry-university collaborations, etc. • Need for broader forum on industrial process development emerged • High level of interest from industrial participants at AIChE National Meetings

5. …Background & History • Expansion of Pilot Plants Area initiated in 1996-1997 by a core group • Proposed name change of “Engineering Division” to “Process Development Division” • Proposed new structure covering key elements of process development • 12A Process Research & Innovation • 12B Pilot Plants • 12C Technology Transfer • 12D Manufacturing • Permanent Division Status granted by AIChE CTOC in 2002

6. Process Development DivisionVision and Goals Our vision is to provide leadership in the development of the next-generation technologies for process development • Promote programming and presentations of process development topics at the Spring and Annual Meetings of the Institute, and at the Process Development Symposium • Promote the interchange of ideas, concepts and history of process development in various aspects, from theory to hardware • Provide a continuous forum for communication, sharing ideas, learning new concepts and benchmarking • Promote networking and communication among those involved in process development • Promote the teaching of process development, thereby improving interactions between industry and academia

7. Process Development Division Structure

8. Current Leadership (2001-2003) • Chair: John E. Corn (Consultant; Professor at Ohio State University) • Chair-Elect: Christine Seymour (Pfizer) • Treasurer: Jean Bender (Genentech) • Programming Chair: Raymond Rooks (Dow) • Membership Chair: Ramesh Rameswaran (Lyondell) • Newsletter Editor: Nicolette Modes (Abbott) • Webmaster: Jack Vinson (Pfizer) • Awards Committee Chair: Glen Wheeler (Alkermes) • International Liaison: Kamlesh Bhatia (DuPont) • Process Development Symposium Chair: Cawas Cooper (Air Products) • Special Projects: Ka M. Ng (Hong Kong UST) • 12a Cheryl Teich (Rohm & Haas), Yinlun Huang (Wayne State), Lionel O’Young (CWB Technology) • 12b A. (Bob) Duggal (Ethyl), David Edwards (Zeton), Joe Powell (Shell) • 12c John F. Peragine (Bristol-Myers Squibb), Annette Johnston (Abbott), Osman Aboul-Nasr (Fluor) • 12d John Battler (Consultant), Helen Lou (Lamar), Stephanie Sullivan (Merck)

9. Area 12A:Process Research & InnovationMission and Goals • Foster process innovation by applying Chemical Engineering principles to the synthesis of novel operations for new product manufacture and step changes in existing technology. • The PR&I area will be a meeting ground for diverse academic and industrial practitioners of Process Innovation. • Its programming and activities will explore the components of successful process innovation, and distribute this shared knowledge to the Institute membership.

10. Area 12A:Pilot PlantsMission and Goals The Pilot Plant Area is a forum for active interchange of ideas and for the continual improvement of Pilot Plant contributions to quality research and effective scale-up. AIChE programming, benchmarking, operation reviews, and extensive networking form the backbone of the Area activities.

11. Area 12C:Technology TransferMission and Goals • Provide a forum to share and build on technology transfer (TT) principles and experiences of professional colleagues from different disciplines. • Generate ideas to develop TT work processes aimed at extracting value from internal and external technology for speedy and cost effective commercialization of new processes and products.

12. Area 12D:ManufacturingMission and Goals • Provide programming to enhance the professional development of AIChE members and industry colleagues who affect manufacturing process improvements. • Expand in scope to include other aspects of manufacturing technology and secure active participation from a greater breadth of the ChE population. Maintain strong ties with internal and external groups.

13. PDD Membership Trend

14. Programs & Activities:Past & Future • Technical Sessions at National AIChE Meetings • Process Development Symposiums • Group Planning Meetings • Group Dinners

15. Area 12A:Process Research & InnovationRecent Programming Sessions • 2003 Annual Meeting, San Francisco: Topical Conference: Process Research and Innovation • Innovation in Pharmaceutical and Biotechnology Development and Manufacturing • Innovation in Green Chemistry and Sustainable Process Development • Selling Innovation in the Traditional CPI • Process Innovation as a Route to Shorter Time to Market • Innovation in Green Chemistry and Sustainable Process Development - Measuring it and Making it Happen • 2003 Spring Meeting, New Orleans • The Role of Innovation in Extending the Life of Mature Products

16. Session Papers:Selling & Implementing Innovation in the Traditional CPI • Implementing a High-value Novel Technology in Petrochemical Setup • The Road to Innovation --- Contingency Cost Reduction • A One-Step, Greener Process for Adipic Acid • Promoting Innovation with Advanced Knowledge Management • Microfluidic Chips: A New Platform for Performing Chemical Analysis of Drilling Fluid • McPIPE- Passively Heated Subsea Flowline

17. Area 12A:Process Research & InnovationFuture Programming Sessions • 2004 Annual Meeting, Austin: Topical Conference: 21st Century Process Development Tools • From the university to the factory - successful collaborations in innovation • Innovation in Consumer Products • Industrial Preparative Chromatography • Innovative Design Methodologies • 2004 Spring Meeting, New Orleans • Innovation in Fuel Processing

18. Area 12A:Pilot PlantsRecent Programming Sessions • 2003 Annual Meeting, San Francisco: Topical Conference: Pilot Plants in Process Development • The Role of Pilot Plants in Process Development • Pilot Plants: The Uniqueness of Small Scale • Traditional and Novel Pilot Plant Reactors • Key Factors in Successful Pilot Plant Design and Operation • Pharmaceutical Pilot Plants • 2003 Spring Meeting, New Orleans • New Trends and Best Practices in Pilot Plant I and II • 2002 Annual Meeting, Indianapolis • Piloting for Process Intensification and Miniaturization

19. Session Papers:The Role of Pilot Plants in Process Development • Pilot Plants: A New World, A New Mission • Pilot Plants in Process Development • Changes in the Operation and Use of Pilot Plant for Support of Refining • Pilot Plants in a Changing Industry Environment • The Changing World of Pilot Plants • The New Pharmaceutical Pilot Plant

20. Area 12A:Pilot PlantsFuture Programming • 2004 Annual Meeting, Austin: • Bioreactor Pilot Plants • Elegant Experimental Methodology in Pilot Plants • Membrane Process Design and Scale-up Considerations • Pilot Plant Benchmarking Study Results • R&D Management Topical 3: Six Sigma Usage in the CPI • 2004 Spring Meeting, New Orleans • Mixing in Pilot Plants

21. Area 12A:Pilot PlantsOther Activities … • Pilot Plant Benchmarking • Discussion Forum on Pilot Plants • Pilot Plant Tours

22. Benchmarking Objectives • Compile “best” practices and “norms” in areas of interest to Pilot Plant group • Survey members from a cross section of CPI • Disseminate results • In a way that members and organizations can benchmark effectively with • In a format that does not raise competitive issues

23. Benchmarking Topics • Business objectives for pilot plants • Staffing for construction and operation of Pilot Plants • Pilot Plant Automation • EH&S Issues/Consideration in Pilot Plants

24. Project Timeline • Finalize topics - Complete • Finalize questionnaires – 4Q 2002 • Drafted by team members with input from Area 12B • Multiple choice format with area for comments • Circulate for responses – 2Q 2003 • Team chose to send to PDD membership to obtain a representative cross section of CPI, representing major industry sections • 22 Respondents to date • Compile responses – 3-4Q 2003 • Analyze by industry section/demographic • Present at next AIChE/PDD Event • Austin 2004 • Full session with 4 papers and discussion format

25. Area 12C:Technology TransferRecent Programming Sessions • 2002 Annual Meeting, Indianapolis • Commercialization of Separation Unit Operations • Pharmaceuticals: Rapid Process Development and Manufacture • 2003 Spring Meeting, New Orleans • Analytical Technology Transfer: The Good, the Bad and the Ugly

26. Area 12D:Manufacturing Recent Programming Sessions • 2002 Spring Meeting, New Orleans • Process Improvements in Existing Processes I • Implementing Innovation in the Manufacturing Setting • Process Improvements in Existing Processes II • 2002 Annual Meeting, Indianapolis • PHA/HAZOPS for New Systems and Processes in Manufacturing • Pharmaceuticals: Rapid Process Development and Manufacture • 2003 Spring Meeting, New Orleans • Case Studies and Lesson Learned

27. Area 12D:Manufacturing Future Programming • 2004 Annual Meeting, Austin: • Spend Capital or Toll it • Technical Project Management • 2004 Spring Meeting, New Orleans • Case Studies and Lesson Learned • Environmental Challenges in Manufacturing • Engineering Issues in Security of High Hazard Facilities

28. PD Symposium:“Accelerating Process Development for Growth”June 2003, Poconos, PA • Batch Process Development for Pharmaceuticals & Specialty/Fine Chemicals • Continuous Process Development for Petro/Commodity Chemicals • Visionary Talks and Panel Discussion • Table-Top Displays

29. Batch Session • “An Integrated Development Approach to API Process R&D” • “Process Development for the 21st Century Pharmaceutical Industry” • “Notes on Process Development: Pharmaceutical Intermediates and APIs” - Ed Paul • “Pick the Best Route: We Need It Tomorrow”! • “Successful Chemical Process Development: Profitable Specialty Chemical Products Using Winning Work Practices”

30. Continuous Session • “Recent Advances in the Application of Molecular Sieve Catalysts for the Commercial Production of Aromatics” • “Development of Catalyst Impregnation Processes” • “Using Physical Property Models to Accelerate Process and Product Development” • “Flow Visualization and Modeling of Opaque Multiphase Flow Reactors” • “Accelerating Process Development for Growth” • “Dinosaurs to Small Furry Animals- The Evolution of Process Development Methodology”

31. Visionary Talks • Dr. Arthur Andrews VP Process R&D, Merck “Chemical Process Development for Pharmaceuticals - Challenges, Opportunities, and Future Directions” • Dr. Kenneth Kem VP Chemicals Technology, Air Products “Use Process Innovation to Remodel Performance Products Businesses” • Dr. Frits Dautzenberg VP Technology Development, ABB Lummus “Accelerating Innovation in Process Development”

32. Table Top Displays (partial list) • Chemstations, Inc. • CWB Technology • HEL • Lasentec • Mettler Toledo AutoChem • Molecular Knowledge Systems, Inc. • Remspec Corp. • Xytel Corp. • Zeton Inc. • ChemEngine

33. 2004 Process Development Symposium • “Working Right on the Right Thing” • June 20-23, 2004; Chicago • Topics • Technology and Knowledge • Pilot Plants • Modeling And Optimization as a Tool for Effective Process Development • Laboratory Tools for Effective Process Development • Working Right for the Future

34. Division Awards • Process Development Practice Award (Spring) sponsored by Zeton • Excellence in Process Development Research Award (Fall) sponsored by Pharmacia (Pfizer) • The Process Development Division Student Paper Award (Fall) sponsored by Lilly

35. Long Range Plan

36. Benefits to Division Members • Professional Development • Opportunities for Networking • Benchmarking Resources • Recognition • News and Information

37. Professional Development • Attend Division sponsored activities • Technical sessions at AIChE meetings • Process development symposiums • Topical conferences • Short courses • Develop leadership and organizational skills by participating in Division activities

38. Networking • Interact with peers from industry and academia at group dinners and mixers • Develop relationships for mentoring and career development • Access a comprehensive membership list of peers active in Process Technology

39. Benchmarking • Best practices in Process Technology • Round table & panel discussions on specific topics • Plant, pilot plant & laboratory tours • Consortia sponsorships (future) • Centers of excellence (future)

40. Recognition • Annual Division sponsored award for outstanding contributions to the field of Process Technology • Certificates/plaques recognizing service to the Division

41. News and Information • Division web-site • www.pd-aiche.org • Programming information • Past, current and future events • Discussion groups (future) • Semi-annual newsletter

42. How to Get Involved • At AIChE National Meetings in the Spring & Fall • Attend our Program Sessions • Come to Area Meetings • Join us at the Group dinner and other social events • Chair/Vice-Chair a session • Nominate a colleague for PD Awards • Join the PD Division when you renew your annual AIChE Membership