Automation of cellular therapies to scale up production and meet regulatory requirements.

1. Devices & Drugs – the new marriage
Cellular Therapies: Enabling commercial viability through
integrated automation
Edmund O’Shaughnessy
Manufacturing Innovation
© 2008 Invetech Pty Ltd

2. Basic & Applied
Research
Business
Creation
Managing
a going
concern
‘From Science to Profits’
‘From science project to profitable business’, © Richard G. Caro, 2004

3. ‘You can’t get
there from
here sir!’

4. ‘The Innovation Continuum’
‘From science project to profitable business’, © Richard G. Caro, 2004
Basic
research
Directed
research
Product
research
Product
development
Market
adoption
Discovery Stage Business Creation Stage
?

5. ‘The Process is
the Product’
http://www.fda.gov/cder/biologics/qa.htm

6. What regulatory requirements
must I meet?
How can I scale my process for
volume production?

7. Fully automated clinical
processing platform
manipulating patient derived
molecular materials in single-
use devices

8. Hold your horses!

9. A Cost Model
can help direct development
priorities and generate
investment scenarios
Design concept estimates
Patient volumes
Process timings
Market projections
Scale-up timelines
Capital Investment Scenarios
Staffing levels
Cost Of Tests
Cost Of Goods
Manual/Automation cross-over
Breakeven points

10. Justifying Automation
0
50 100 200 400 800 1,600 3,200 5,000 7,000 10,000
Patients per year processed
Costperpatient
Manual Semi Automated Fully Automated

11. Capacity Planning
Market prediction
Planned capacity
Cumul capital
Schedule
CapitalInvestment($'000)
Devices/month

12. Start early with your regulatory
requirements

13. Risk-driven Design

14. Putting the pieces together

15. In Summary

16. Know your
process

17. Be a parrot!
‘What are the risks,
what are we doing
about them?’

18. The Regulator is not
the enemy

19. Automation is your friend

20. Get the money!

21. People want you to
succeed

22. Thank you for your attention
Any questions?
Edmund O’Shaughnessy
Manufacturing Innovation
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