INTRODUCING THE AIChE PROCESS DEVELOPMENT

DIVISION (#12) New Jersey Section Meeting

September 9, 2003

John F. Peragine

Bristol-Myers Squibb

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Agenda

• Effective process development

• The “new” Process Development division

• Benefits to New Jersey section

• Strategies and key deliverables to members

• Important achievements

• Future programming

• Summary of benefits

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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

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The “New” Process Development Division

• Benefits to New Jersey section

• History

• Current structure- Process Research and Innovation, Pilot Plants, Technology Transfer, Manufacturing sub-groups

• Vision/goals/leadership

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Benefits to New Jersey Section

• Small but growing division follows product/process development from initial research, through scale-up, transfer of technology, and into manufacturing

• Direct linkage to national AIChE events

• Networking with peers and students

• Co-sponsoring opportunities with many divisions (in particular, Division #15)

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Process Development DivisionBrief History

• PDD started in 1984 as Pilot Plant Committee/Area in the Engineering Group (Group 12)

• In 1996, the expansion of the Pilot Plant Area was agreed upon and the Group name was changed from “Engineering” to “Process Development”

• In 1997, a new structure of the group was established, consisting of 12a Process Research and Innovation, 12b Pilot Plants, 12c Technology Transfer, 12d Manufacturing

• In 2000, probational Division status was granted by CTOC

• In 2002, permanent Division status was granted by CTOC

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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 (first one in 6/03)

• 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

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Process Development DivisionCurrent Leadership

• 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)

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Advantages of Becoming a Division

• Increased credibility & visibility– Encourage more participation in the division– Easier to get management approvals for attendance– Improved recruitment of new members– Make it easier to present and share info at

meetings • Common ground - linkage between Academia and

Industry

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Strategies and Key Deliverables to Members

• Technical/topical sessions at AIChE mtgs• Process development focussed

symposia/workshops/seminars/short courses• Proc. Dev. Resources; latest news and info• Professional development; networking;

recognition• Benchmarking opportunities• Dialog among specialists; plant tours

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Professional Development

• Attend Division sponsored activities– Technical sessions at AIChE meetings

– Process development symposia

– Topical conferences

– Short courses

• Develop leadership and organizational skills by participating in Division activities

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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 - future

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Benchmarking

• Best practices in Process Technology– Round table & panel discussions on specific topics

– Pilot plant benchmarking survey - results in 11/03 at SF mtg; technology transfer benchmarking survey anticipated for 2004

• Plant, pilot plant & laboratory tours - future• Consortia sponsorships• Centers of excellence - future

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Recognition

• Annual Division sponsored awards for outstanding contributions to the field of Process Development and Technology

• Certificates/plaques recognizing service to the Division

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News and Information

• Division web-site (www.pd-aiche.com)– Members only area with enhanced features - future

• Discussion groups

• Links to key resources– Consultants, contract research/manufacturing, suppliers, related societies, etc.

• Membership list

• Resume/job postings

• Division newsletter

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Important Achievements

• Permanent divisional status• Programming (topical and general sessions at

Spring national and Fall annual mtgs)• The First Process Development Symposium• Web site & newsletter• Increased membership• Awards• Division by-laws

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Programming

• F99 Dallas topical on research to development; S00 topical on technology transfer

• F00 LA & S01 Houston sessions• F01 Reno topical on batch processing; S02 New

Orleans topical on process improvement• F02 Indianapolis & S03 New Orleans• First PD Symposium (6/03) in Poconos 72 attendees• F03 SF topicals on innovation & pilot plant• Second PD Symposium - Summer 2004 Chicago area• S04 New Orleans & F04 Austin

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Spring 2003 - New Orleans

• 12 a - Role of Innovation in extending the life of Mature Products

• 12 b - New Trends and Best Practices in Pilot Plants I and II

• 12 c – Analytical Technology Transfer: the Good, the Bad, and the Ugly

• 12 d - Case Studies and Lessons Learned

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First PD Symposium - “Accelerating Process Development for Growth”

22 June 2003 (evening reception) - 25 June 2003 @ Split Rock, 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

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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”

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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”

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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”

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Table Top Displays (partial list)

• Chemstations, Inc.• CWB Technology• HEL• Lasentec• Mettler Toledo AutoChem• Molecular Knowledge Systems, Inc.• Remspec Corp.• Xytel Corp.• Zeton Inc.

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Website (www.pd-aiche.com)

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Membership

• Number of members 2000-2001: 138• Number of members 2001-2002: 353• Number of members 2002-2003: over 500

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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

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Division Bylaws

Article I – Name and Objectives

Article II – Membership

Article III – Organization

Article IV – Meetings

Article V – Elections

Article VI – Dues and Finances

Article VII – General Provisions

Article VIII – Amendments

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Future Programming

• Sessions at San Francisco 11/03 annual mtg• Sessions at New Orleans 3/04 spring mtg• 2nd Process Development Symposium - “Working

Right on the Right Thing” June 2004 in Chicago area

• Sessions at Austin 11/04 annual mtg• Future topics

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Fall 2003 - San Francisco

• Two topicals– Process Research and Innovation

– Pilot Plants

• Other Division Sessions• Several co-sponsored sessions

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Fall 2003 - Process Research and Innovation Topical

• Innovation in Pharmaceutical Process Development

• Innovation in Green Chemistry and Sustainable Process Development

• Selling and Implementing Innovation in the Traditional CPI

• Process Innovation as a Route to Shorter Time to Market

• Process Innovation in High-Value Add Product Development

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Fall 2003 - Pilot Plant Topical

• 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

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Fall 2003 - Supplemental

• Process Development for APIs and Pharmaceutical Dosage Formulation

• Challenges in the Pharmaceutical Industry in view of FDA Regulatory Issues (focussing on PAT)- Dr. Ajaz Hussain (FDA), invited speaker; others speakers from industry/academia; panel discussion

• Biopharmaceutical Separations

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Spring 2004 - New Orleans

• Innovation in Fuel Processing• Mixing in Pilot Plants• Barriers to effective technology transfer (external

and internal)• Environmental Challenges in Manufacturing• Engineering Solutions to Facility Security

Challenges• Case Studies and Lessons Learned• CFD of Multiphase Flows

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Fall 2004 - Austin

• “Tool Time”- process development tools• From the University to the Factory - Successful

Collaborations in Innovation• Innovation in Consumer Products• Industrial Preparative Chromatography• Innovative Design Methodologies• Bioreactor Pilot Plants• Membrane Process Design and Scale-up

Considerations

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Fall 2004 - Austin (cont’d)

• R&D Management Topical 3: Utilizing Six Sigma & Design for Six Sigma in R&D

• Process Analytical Technologies (PAT) for Pharmaceutical and Biopharmaceutical Applications

• “Spend Capital or Toll it” (efficient energy usage in manufacturing)

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Some Future Topics

• Fuel Cell and Gas to Liquid Fuels Pilot Plants• Pilot Plant Economics• Safety in Pilot Plant Design and Operation• Pilot Plant Success Stories• Unit Operations in Pilot Plants• Chemists are from Mars / Engineers are from Venus• Tech Transfer to/from Third Party Manufacturers• Process/Equipment Standardization

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Some Future Topics (cont’d)

• Special Issues with International Tech Transfer• Corporate Partnerships (University to Industry)• Internal and External (or Outsourced) Process

Development• Government to Industry Tech Transfer• Information Technology Tools• Future Prospects for Tech Transfer

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Summary of Benefits

• Programming follows key steps of successful process development

• Opportunities for growth and exposure at national AIChE venues

• Dynamic division with co-sponsoring possibilities with several other AIChE divisions

• “Good fit” with NJ industry and academia