1. Biopharmaceutical Manufacturing Capacity and Production Trends Eric S. Langer President, BioPlan Associates, Inc.

2. BioPlan Associates, Inc Market research and assessments since 1989 New technology evaluation Life sciences ROI models Pricing studies Commercialization Education and Training: –Johns Hopkins and American Universities –Custom programs: Marketing, Management, ROI

4. Why the Annual Studies Benchmark industry performance Improve strategic and tactical planning Identify and quantify trends

5. Bottom-Line Objectives Provide information that helps: –Reduce production costs –Identify best technologies that reduce costs –Help vendors ensure they are developing products the industry is demanding, sooner.

6. Thinking Forward to 2006 Your Input will be Invaluable

7. 3 rd Annual Report & Survey Methodology 187 Biopharmaceutical developers, CMOs 190 suppliers Worldwide assessment Web-based methodology Not intended to identify individual companies, their specific capacity, or utilization Segments –BioPlan Associates contacts –IBC’s / BioProcess International contacts

8. Report Authors BioPlan Associates, Inc. –Eric S. Langer, President Bioprocess Technology Consultants, LLC –James V. Blackwell, PhD, Sr. Consultant –Howard L. Levine, PhD, President –Thomas C. Ransohoff, Sr. Consultant

9. Report Coverage Demographics Capacity Utilization Capacity Constraints / Planned Capacity Expansion Outsourcing: Critical Issues in Outsourcing Use of Disposables Downstream Purification Training in BioManufacturing Suppliers to BioManufacturing

10. Demographics Areas of Involvement

11. Demographics Biopharmaceutical Systems

12. Demographics Phase of Development

13. Capacity Utilization Percent Capacity, by System Current Capacity Constraints, Perceptions Future Capacity Constraints Factors Creating Capacity Constraints Plans to Avoid Capacity Constraints Plans for Capacity Expansion (CMO, Biotherapeutic Developer)

14. Capacity Utilization Average Utilization as % Operating Capacity

15. Capacity Constraints “My organization is currently experiencing capacity constraints,” % 2003 - 2005

16. Capacity Constraints Biotherapeutic Developers vs CMOs Biotherapeutic developers are 2x as likely to experience significant capacity constraints, compared to CMOs.

17. Factors Creating Capacity Constraints Lack of Scientific Staff Problems w/ Downstream Purification Physical Capacity of Fermentation Equipment Lack of Financing for Expansion Unable to Optimize System / Quality Control / Unable to Optimize Yield Lack of Trained Tech/ Production Staff

18. Key Areas to Avoid Capacity Constraints Develop cost-effective disposable/ single-use technologies Increase training in production areas Optimize cell culture systems to increase upstream performance Improve downstream purification performance Streamline FDA regulatory process Fund more early-stage scale-up production technologies

19. Future Capacity Expansion Projected Avg % Increase Production Capacity by 2010

20. Future Capacity Expansion % Projecting > 100% Increase in Capacity by 2010

21. Outsourcing  By Production System  Outsourcing in 2010  Critical Issues in Outsourcing

22. Outsourcing by 2010 % Planning to Outsource SOME Production, by 2010

23. Critical Outsourcing Issues CMO demonstrates track record with products similar to mine CMO is able to stick to a schedule CMO has production platforms relevant to my product CMO demonstrates cost effectiveness (ROI) of their Services CMO must establish a good working relationship

24. Use of Disposables Types used Percentage used Reasons for increased use (CMOs & Biotherapeutic Developers) Factors restricting use Current spending

25. Factors Restricting Use of Disposables Don’t want to be dependent on 1 Vendor Breakage of Bags/ Loss of Product Can’t change for regulatory reasons Leachables and Extractables Already invested in current system Current disposables systems don’t meet my requirements No lifetime operating cost data exists

26. Downstream Purification Where are Improvements Needed? Magnitude of Problems Associated with Microfiltration

27. Training in Biopharmaceutical Manufacturing Types of Training Percent biomanufacturing workforce trained in past 12 months Internal vs External Training Types Training by Facility Size

28. Suppliers to BioManufacturing & Life Sciences Biomanufacturing Market Growth What Suppliers Must Demonstrate to Customers

29. What’s Next for 2006 Downstream Purification Disposables HTP Assays and Data Management Optimization of Yield and Performance Training in Production Areas

30. What’s Next for 2006 Your Input is Invaluable