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Transcript of Biopharmaceutical Manufacturing Capacity and Production Trends Eric S. Langer President, BioPlan...
![Page 1: Biopharmaceutical Manufacturing Capacity and Production Trends Eric S. Langer President, BioPlan Associates, Inc.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649e0b5503460f94af377a/html5/thumbnails/1.jpg)
Biopharmaceutical Manufacturing Capacity and Production Trends
Eric S. Langer
President, BioPlan Associates, Inc.
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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
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![Page 4: Biopharmaceutical Manufacturing Capacity and Production Trends Eric S. Langer President, BioPlan Associates, Inc.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649e0b5503460f94af377a/html5/thumbnails/4.jpg)
Why the Annual Studies
• Benchmark industry performance
• Improve strategic and tactical planning
• Identify and quantify trends
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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.
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Thinking Forward to 2006
• Your Input will be Invaluable
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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
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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
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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
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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
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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
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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
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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)
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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
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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
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Capacity ConstraintsBiotherapeutic Developers vs CMOs
• Biotherapeutic developers are 2x as likely to experience significant capacity constraints, compared to CMOs.
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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
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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
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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
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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
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Outsourcing
By Production System
Outsourcing in 2010
Critical Issues in Outsourcing
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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
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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
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Use of Disposables
• Types used
• Percentage used
• Reasons for increased use (CMOs & Biotherapeutic Developers)
• Factors restricting use
• Current spending
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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
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Downstream Purification
• Where are Improvements Needed?
• Magnitude of Problems Associated with Microfiltration
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Training in Biopharmaceutical Manufacturing
• Types of Training
• Percent biomanufacturing workforce trained in past 12 months
• Internal vs External Training Types
• Training by Facility Size
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Suppliers to BioManufacturing & Life Sciences
• Biomanufacturing Market Growth
• What Suppliers Must Demonstrate to Customers
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What’s Next for 2006
• Downstream Purification
• Disposables
• HTP Assays and Data Management
• Optimization of Yield and Performance
• Training in Production Areas
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What’s Next for 2006
• Your Input is Invaluable