Biopharmaceutical
Manufacturing Capacity
and Production Trends
Eric S. Langer
President, BioPlan Associates, Inc.
BioPlan Associates, Inc
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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
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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
Demographics
Areas of Involvement
0
10
20
Large-Scale Cell Culture
Production for Therapeutics
52.9
Large Scale Microbial
Fermentation
Lg Scale CMO
30
41.7
29.9
Other CMO
27.3
Vaccine Production
25.7
40
50
60
Demographics
Biopharmaceutical Systems
0
10
20
30
Mammalian Cell Culture
75.5
Microbial Fermentation
Yeast
Insect Cells 9.8
Plant Cells 3.3
Other 6.5
40
62
29.9
50
60
70
80
Demographics
Phase of Development
0
10
20
30
40
R&D
73.3
Preclinical
75.4
Phase I
62.6
Phase II
63.6
Phase III
Marketed
46.5
42.8
50
60
70
80
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 Utilization
Average Utilization as % Operating Capacity
0
10
20
30
Mammalian Cell
Culture
68.8
Microbial
Fermentation
Yeast
Plant Cells
Insect Cells
60.5
44.9
48.1
40.3
40
50
60
70
80
Capacity Constraints
“My organization is currently experiencing capacity
constraints,” % 2003 - 2005
0
Strongly Agree
10
20
30
40
612.5
21.527
Agree
Neutral
25 32
Percent 2003
2005
2128.5
Disagree
Strongly Disagree
10.4
10
4
Don't Know 2.1
Capacity Constraints
Biotherapeutic Developers vs CMOs
• Biotherapeutic developers are 2x
as likely to experience significant
capacity constraints, compared to
CMOs.
Factors Creating Capacity
Constraints
0
10
20
Lack of Trained Tech/ Production
Staff
39.6
Lack of Financing for Expansion
38.9
Physical Capacity of Fermentation
Equipment
35.4
Lack of Scientific Staff
30.6
Unable to Optimize System / Quality
Control / Unable to Optimize Yield
13
Problems w/ Downstream Purification
12
30
40
50
Key Areas to Avoid Capacity
Constraints
0
10
20
Optimize cell culture systems to
increase upstream performance
54.2
Improve downstream purification
performance
43.8
Streamline FDA regulatory process
38.9
Fund more early-stage scale-up
production technologies
36.1
Increase training in production areas
35.4
Develop cost-effective disposable/
single-use technologies
30
24.3
40
50
60
Future Capacity Expansion
Projected Avg % Increase Production Capacity by 2010
0%
10%
20%
Mammalian Cell
Culture
54%
Microbial
Fermentation
40%
Yeast
30%
Plant Cells
28%
Insect Cells
30%
14%
40%
50%
60%
Future Capacity Expansion
% Projecting > 100% Increase in Capacity by 2010
0%
5%
Mammalian Cell
Culture
12%
Yeast
12%
Insect Cells
15%
28%
Microbial
Fermentation
Plant Cells
10%
11%
8%
20%
25%
30%
Outsourcing
 By Production System
 Outsourcing in 2010
 Critical Issues in Outsourcing
Outsourcing by 2010
% Planning to Outsource SOME Production, by 2010
0%
10%
20%
30%
Mammalian Cell
Culture
62%
Microbial
Fermentation
61%
58%
Yeast
67%
Plant Cells
Insect Cells
40%
40%
50%
60%
70%
80%
Critical Outsourcing Issues
0
20
CMO must establish a good
working relationship
40
52.8
CMO has production platforms
relevant to my product
50
CMO is able to stick to a schedule
47.2
CMO demonstrates track record
with products similar to mine
47.2
CMO demonstrates cost effectiveness
(ROI) of their Services
37.7
60
Use of Disposables
• Types used
• Percentage used
• Reasons for increased use (CMOs &
Biotherapeutic Developers)
• Factors restricting use
• Current spending
Factors Restricting Use of
Disposables
0
0 .1
0 .2
0 .3
Leachables and Extractables
69%
Breakage of Bags/ Loss of Product
58%
Don’t want to be dependent on 1 Vendor
57%
Already invested in current system
55%
Current disposables systems don’t meet
my requirements
54%
No lifetime operating cost data exists
Can’t change for regulatory reasons
50%
34%
0 .4
0 .5
0 .6
0 .7
0 .8
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
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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