Eliot Randle, Head of Global Solutions Consulting at IDBS, speaks on optimizing operations, improving quality and enhancing insight in bioprocessing with the IDBS Bioprocess Execution System.

1. © 2014 ID Business Solutions. All Rights Reserved
Bioprocess Execution System
Optimize Operations, Improve
Quality and Enhance Insight in
Bioprocessing
Dr Eliot Randle, MBA
Head of Solutions Consulting

2. ©2014 IDBS, Confidential
Results of a survey of development groups in 104 pharmaceutical organizations, PharmaManufacturing.com
Data management – a common problem
Five hours per week
spent looking for data to
prepare reports
Almost 20% of the time,
the data needed cannot be
found
10% of studies have to be
rerun because the data is
not accessible or cannot
be retrieved

3. ©2014 IDBS, Confidential
Information silos, limited collaboration, laborious tech transfer
Product and process lifecycle – current state
Research Early Development Late Development Commercialization

4. ©2014 IDBS, Confidential
Product and process lifecycle – current state
ERP
Instrument
Instrument
LIMS LIMS
SDMS EBR
Historian
MESDB
CDS
Excel
LIMS
DevelopmentResearch Commercialization
DB
Paper
Notebook
Excel
Paper
Record
Paper
Record
Paper
Notebook
Paper
notebook
Excel
Paper
record
Paper
record
Paper
notebook

5. ©2014 IDBS, Confidential
And to get there you need solid foundations
Most R&D
organizations
have a vision… …the
paperless
lab of the
future?
quality,

6. ©2014 IDBS, Confidential
Wherever you want to go,
key drivers will influence your route…
Accelerated innovation –
and more of it
Products to market faster
Improved margins

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Making connections…
Link data to data
Link data to people
Link people to people
1010 0101

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And we all face obstacles
that shape that journey
All of us are on a journey to improve
our research and development

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Any major leap to upgrade your
operation carries consequences

10. ©2014 IDBS, Confidential
Low to higher risk & costs / Saving minutes to years
Approach – options to support your project & vision
Simple data modeling
Capturing unstructured data
Simple structured data
Structured data & process
Cross collaboration
Enterprise analysis & insight

11. ©2014 IDBS, Confidential
Low risk & costs / Saving hours
CASE 1: VISION – knowledge management
Clear, defined vision
Hundreds of users across R&D
Paper removal – time saving
IP capture at source and easy data access
Reduction of repeated experiments
Duration: less than 6 months

12. ©2014 IDBS, Confidential
An evolving vision
300 users across 4 global sites
Increased data quality
Faster turnaround of reports
Enrich customer interactions
Process harmonization and SOP
consolidation
Increased transparency to auditors
Duration: 12-18 months
Higher risk & costs / Saving weeks to months
CASE 2: VISION – a platform for continuous improvement

13. ©2014 IDBS, Confidential
IDBS: Driving efficiency, quality & insight
Optimize
processes
and integrate data
Deliver product
and process
insight

14. ©2014 IDBS, Confidential
IDBS platform
DevelopmentResearch IDBSIDBS Commercialization
IDBS platform
Reporting
Workflow Execution
Data Integration
ERP
CDSLIMS MESHistorianDatabaseInstrument CDSLIMS MESHistorianDatabaseInstrument
Replace paper & Excel
Provide collaboration platform
Protect and secure data

15. ©2014 IDBS, Confidential
Bioprocess Execution System
Protein & cell line analytics
Cell line
development/
maintenance
Upstream
processing
Downstream
processing
Central services
(Media & buffer preparation, equipment management)

16. ©2014 IDBS, Confidential
Legacy cell culture workflow
Daily information
capture (Paper/Excel)
Manual step:
Copy & paste or
transcription
Instruments
Online data
Observations
Analytical
requests
Feed/pump
rate
calculation
Fermentation summary (Excel/Word)
Daily
information
capture
day n
Daily
information
capture
day 1
Cell line comparisons (Excel/Stats)
Cell line
maintenance
Media/feed
prep
(paper)

17. ©2014 IDBS, Confidential
Reducing duplication, eliminating transcription, increasing insight
Streamlined workflow – with IDBS
Single integrated environment
Daily
information
Feed rate
calculation
Fermentation
summary
Instruments
Online Data
I
N
T
E
R
F
A
C
E Analytical
Media prepStock prep
LOOKUP
REQUEST
SYSTEM
Lot tracking
Performance
reports
Development
histories
APR, BLA, NDA
Cell line
comparisons
Fermentation
report
QUERY
Q
U
E
R
Y
LOOKUP
LOOKUP
Cell line
maintenance

18. ©2014 IDBS, Confidential
Key outcomes
 Improvements in operational efficiency
• Reduced data admin
• Reports take minutes, not days
• Scientists have more time to innovate
 Higher quality
• Significant reductions in QA overheads
• Costly errors engineered out of the process
• A platform for quality Initiatives, such as QbD
 Greater insight across the product and process
• Simplified knowledge sharing internally and externally
• Enhanced decision-making
• Streamlined technology transfer

19. ©2014 IDBS, Confidential
Low to higher risk & costs / Saving minutes to years
Approach – options to support your project & vision
Simple data modeling
Capturing unstructured data
Simple structured data
Structured data & process
Cross collaboration
Enterprise analysis & insight

20. ©2014 IDBS, Confidential
Delivering real business value
and tangible ROI at every step
 Higher quality data
 Superior analysis
 Increased trust
 Greater insight
 More relevance
 Higher security

21. ©2014 IDBS, Confidential
Why IDBS?
 Interoperable data and process
 Fast, easy access to information
 Fully captured and protected IP
 Guaranteed quality and compliance
 Experts with deep domain expertise
 More insight means more innovation