biopharmaceutical manufacturing capacity and production trends eric s. langer president, bioplan...
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Biopharmaceutical Manufacturing Capacity and Production Trends
Eric S. Langer
President, BioPlan Associates, Inc.
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
Why the Annual Studies
• Benchmark industry performance
• Improve strategic and tactical planning
• Identify and quantify trends
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.
Thinking Forward to 2006
• Your Input will be Invaluable
3rd 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
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
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
DemographicsAreas of Involvement
52.9
41.7
29.9
27.3
25.7
0 10 20 30 40 50 60
Large-Scale Cell CultureProduction for Therapeutics
Large Scale MicrobialFermentation
Lg Scale CMO
Other CMO
Vaccine Production
DemographicsBiopharmaceutical Systems
75.5
62
29.9
9.8
3.3
6.5
0 10 20 30 40 50 60 70 80
Mammalian Cell Culture
Microbial Fermentation
Yeast
Insect Cells
Plant Cells
Other
DemographicsPhase of Development
73.3
75.4
62.6
63.6
46.5
42.8
0 10 20 30 40 50 60 70 80
R&D
Preclinical
Phase I
Phase II
Phase III
Marketed
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)
Capacity UtilizationAverage Utilization as % Operating Capacity
68.8
60.5
44.9
48.1
40.3
0 10 20 30 40 50 60 70 80
Mammalian CellCulture
MicrobialFermentation
Yeast
Plant Cells
Insect Cells
6
27
32
21
10
4
0 10 20 30 40
Strongly Agree
Agree
Neutral
Disagree
Strongly Disagree
Don't Know
Percent 2003
Capacity Constraints“My organization is currently experiencing capacity
constraints,” % 2003 - 2005
12.5
21.5
25
28.5
10.4
2.1
0 10 20 30 40
Strongly Agree
Agree
Neutral
Disagree
Strongly Disagree
Don't Know
Percent 2005
Capacity ConstraintsBiotherapeutic Developers vs CMOs
• Biotherapeutic developers are 2x as likely to experience significant capacity constraints, compared to CMOs.
Factors Creating Capacity Constraints
39.6
38.9
35.4
30.6
13
12
0 10 20 30 40 50
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
Key Areas to Avoid Capacity Constraints
54.2
43.8
38.9
36.1
35.4
24.3
0 10 20 30 40 50 60
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
Future Capacity ExpansionProjected Avg % Increase Production Capacity by 2010
54%
40%
30%
28%
14%
0% 10% 20% 30% 40% 50% 60%
Mammalian CellCulture
MicrobialFermentation
Yeast
Plant Cells
Insect Cells
Future Capacity Expansion% Projecting > 100% Increase in Capacity by 2010
28%
12%
12%
11%
8%
0% 5% 10% 15% 20% 25% 30%
Mammalian CellCulture
MicrobialFermentation
Yeast
Plant Cells
Insect Cells
Outsourcing
By Production System
Outsourcing in 2010
Critical Issues in Outsourcing
Outsourcing by 2010% Planning to Outsource SOME Production, by 2010
62%
61%
58%
67%
40%
0% 10% 20% 30% 40% 50% 60% 70% 80%
Mammalian CellCulture
MicrobialFermentation
Yeast
Plant Cells
Insect Cells
Critical Outsourcing Issues
52.8
50
47.2
47.2
37.7
0 20 40 60
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
Use of Disposables
• Types used
• Percentage used
• Reasons for increased use (CMOs & Biotherapeutic Developers)
• Factors restricting use
• Current spending
Factors Restricting Use of Disposables
69%
58%
57%
55%
54%
50%
34%
0 0 .1 0 .2 0 .3 0 .4 0 .5 0 .6 0 .7 0 .8
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
Downstream Purification
• Where are Improvements Needed?
• Magnitude of Problems Associated with Microfiltration
Training in Biopharmaceutical Manufacturing
• Types of Training
• Percent biomanufacturing workforce trained in past 12 months
• Internal vs External Training Types
• Training by Facility Size
Suppliers to BioManufacturing & Life Sciences
• Biomanufacturing Market Growth
• What Suppliers Must Demonstrate to Customers
What’s Next for 2006
• Downstream Purification
• Disposables
• HTP Assays and Data Management
• Optimization of Yield and Performance
• Training in Production Areas
What’s Next for 2006
• Your Input is Invaluable