A M E R I C A N I N N O VAT I O N AT W O R K
Technical Survey Results
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AMERICAN
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Technical Survey Project
• Assess interest in biopharmaceutical product types
• Assess interest in technical project categories
• Determine level of interest in project sub-topics
General outline of the survey:
• What type of biopharmaceutical product type was of greatest interest?
• What project category was of most interest?
• Host Cell Line Development for Manufacturability
• Process Development / Process Intensification / Platform Development
• Analytical Methods / Process Control
• Reference Standards / Regulatory Science
• Supply Chain Management / IT Solutions
• Within each project category, which project sub-topic was of greatest interest?
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Where the polling was done
Both real-time and on-line polling
R
Q
C
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Regional Meeting Polling
Real-time polling done at 5 regional meetings
• Mix of large and small companies, academia, government, non-profits
• Meeting 1: single session
• Meetings 2-5: separate ‘Industry’ and ‘Academic’ sessions
Qualtrics Industry Survey
On-line survey sent to 207 industry representatives
• Mix of small and large companies (responses anonymous, so final composition unknown)
• Regional Meeting attendees, companies who had provided letters of support for application,
and/or who had been recently contacted for outreach (n=49 respondents)
Combined Survey Data
Pooled data from some Regional Meeting sessions and Qualtrics survey
• Regional Meeting 1 and Meetings 2-5 ‘Industry’ session data included
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Profile of survey respondents
Industry
Academia
Government /
Non-profit
Regional Meeting
73
24
25
122
Qualtrics*
49
0
0
49
122
24
25
171
71.3%
14.0%
14.6%
99.9%
Poll
Total
Total (%)
Total
*Note: the Qualtrics survey was sent to 207 industry contacts, 143 (69.1%) of
these were industrial Regional Meeting attendees; remaining were contacts from
NIIMBL application/outreach efforts
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What product type is of greatest interest to your organization?
(choose 3)
Monoclonal Antibodies
62
Cell Therapies
45
Proteins
44
Gene Therapies
31
Vaccines
29
Bi-specific Antibodies
17
Antibody-drug Conjugates
17
Oligonucleotides (e.g. mRNA, miRNA)
14
Microbiome
10
Peptides
9
Virus-like Particles
9
Exosomes
6
Antibody Fragments
4
Oncolytic Viruses
3
Other
O Other:
1
0
10
20
30
40
50
60
70
Tissue-engineered constructs
Viral vectors
% of respondents
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Which project category is of most interest to your
organization? (choose 2)
Process Development / Intensification /
Platform Development
74
Analytical Methods / Process Control
64
Host Cell Line Development for
Manufacturability
22
Reference Standards / Regulatory Science
21
Supply Chain Management / IT Solutions
17
O Other:
Other
2
0
6
10
20
30
40
50
% of respondents
60
70
80
Gene therapy
Personalized medicine
Precision medicine
Sterility
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Which Host Cell Line Development sub-topic is of most interest to
your organization?
Increased productivity
41
None
21
Alternative cell lines or platforms
20
Other
6
Minimal CHO
5
Addition of genes for insulin, IGF
4
Knock-out RLVP or virus receptors
2
0
7
O Other:
5
10
15
20
25
30
% of respondents
35
40
45
Allogenic cell line
Cell medium selection
Alternative cell lines for vaccines
Suspension cells for viral vector manufacture
Robustness in new product development
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Which Process Development sub-topic is of most interest to your
organization?
Continuous processing and integration
41
Novel or optimized unit operations
22
Scale-up and scale-down models
16
High-throughput platforms
10
Other
None
3
Cell-free synthesis
3
0
8
O Other:
6
5
10
15
20
25
30
% of respondents
35
40
45
Scale out modeling/automation
Viral vector production
Microcarrier scale-up, separations
Live virus vaccine processes
Clean room of the future
Raw materials standardization
Robustness of process development
Closed systems for cell therapy
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Which Analytical Methods/Process Control sub-topic is of most
interest to your organization?
Real-time, in-line methods
45
Predictive models and control algorithms
14
Sensor Development
13
Rapid adventitious agent/sterility testing
13
Automated instrumentation for cell testing
6
Other
6
None
0
9
O Other:
2
5
10
15
20 25 30 35
% of respondents
40
45
50
Mass spectrometry
Optimized QC methods
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Which Reference Standards / Regulatory Science sub-topic is of
most interest to your organization?
Acceptable limits for impurities
28
Reference standards for testing
21
Cell-based standards
17
Surrogate assays
11
Consensus protocols
10
None
8
Other
0
10
O Other:
3
QbD for gene therapy
Process changes
5
10
15
20
% of respondents
25
30
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Which Supply Chain Management / IT Solutions sub-topic is of
most interest to your organization?
Increased raw material understanding
29
Shelf-life and stability
23
System for cell & gene therapy tracking
16
Rapid pandemic response
12
Standardized tools for -omics data
10
Other
5
None
5
0
11
5
O Other:
Biologic delivery to developing countries
Single use
Mobile autonomous clean rooms
Optimization
Efficiency and value understanding
10
15
20
25
% of respondents
30
35
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Conclusions
Product type
Existing products such as monoclonal antibodies, proteins, and vaccines and emerging product such as cell and gene therapies
are both important.
Project type
Process development and Analytical methods/process control projects are of most interest.
Cell Line Development
Increased productivity and alternative cell lines are of the most interest.
Process Development
Continuous manufacturing and process integration is by far of the most interest, followed by new or optimized unit
operations.
Analytical Methods/Process Control
Real-time, in-line methods is by far of the most interest.
Reference Standards / Regulatory Science
Broad interest in a number of different sub-topics, with acceptable limits for impurities being most often mentioned.
Supply Chain Management / IT Solutions
Most interest in increased raw material understanding and shelf life and stability.
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