CMO?????????? - PowerPoint PPT Presentation

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CMO??????????

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Title: CMO Author: ST Last modified by: Vicha Created Date: 6/3/2004 6:54:10 AM Document presentation format: – PowerPoint PPT presentation

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Title: CMO??????????

1
CMO??????????
2
???????

??????????????????????????????????,??????????????
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?????? (Contract Manufacture Organization)???????/
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3
????(CMO)?????

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4
????(CMO)?????

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5
??CMO?????

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6
??CMO?????

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7
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????,????????????300?????,??????11??????????
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8
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9
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??????????????2000??10 ???,???2005 ?????28
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10
CMO???????????
11
CMO??????

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12
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?????CMO?
???CMO????????!

13
??CMO??

?1997??????????????? ? ?
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14
?????CMO???

2000???Tanox(????)????140?,????????????????????
?? ??????????(TBMC)

?????,?2002?????
15
lt????gt ,2003
16
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2002????????????
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17
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18
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?2000???PE Biosystems???????????(primer)???
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?????CMO??
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21
??CMO????

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22
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The biotech market today and the capacity
crunch
Why outsource and factors in choosing a CMO
Sound process development
Increasing regulatory requirements

23
Capacity crunch
We estimate that demand for manufacturing
capacity will exceed current capacity by a factor
of four by 2005 J. P. Morgan. The State of
Biologics Manufacturing, 2001

...the expected needs for increased capacity
would be almost fourfold for fermentation and
monoclonal antibodies and ten fold for mammalian
cell culture. Given that Contract
biomanufacturers only have an increase of one to
two fold planned, this shortfall in capacity
could become significantly painful
High Tech Business Decisions, 2001

24
Capacity crunch today and tomorrow

Is the crunch as crunchy today?
A significant increase in demand for additional
capacity when new products go into clinical
trials and market
Avastin (genentech) and Erbitux (imclone/bms)
will have impact on capacity
The crunch depends very much on success of
products in the clinical trials and improvements
in yields
The crunch may not be evenly spread but will most
likely remain
scarcity re competent specialists with PRACTICAL
experience
Scarcity re capacity at small scale

UBS assumptions Runs per year practically
constant Protein expression level 0.5 (2003), 0.6
(2004), 0.75 (2005), 0.95(2006), Recovery yield
35 (2003), 38 (2004), 40 (2005), 45 (2006),
Probability of success 80 throughout
UBS 2003
25
Solutions for meeting capacity demands

Long term
Expanding capacity or building new facilities
Short term
Improving process development
Increasing staff and adding shifts
Develop better expression systems, optimize media
selection, simplify purification, improve
processes and technologies

26
??

????,????
??CRO????!
??CMO???????!

27
Sound Process Development - the parallel track
Pre clinical Phase I batch
Phase II batch Phase III batch
Tox batch

Manufacturing
Timeline
Minimal process development Focus on few critical
parameters Focus on in-process controls and
analytical methods Focus on impurity profile and
impurity characterization
A
Extensive process development Optimization and
justification of all parameters and extensive
work on critical parameters Focus on yield,
stability, reproducibility and scalability
Reducing number of in-process control and spec.
analyses
B
Process A Discovery processLots of steps Low
yield Low purity Low stability
Process B Manufacturing processFewer steps Good
yield High purity Good stability
28
To build or not to build

Investment of 200-500 million for new
commercial facility
3-6 years completion from design to on-stream
In the end time and money is more than budgeted
Need to employ gtmany competent employees as
biomanufacturing is complex
Easier access to capacity through partnering
between haves and haves-not
Agonist (small quantities) vs. antagonists (large
quantities) considerations
Timeline
Too early? What if candidate fails in CTs
Too late? Lack of revenue stream

29
THINK PRODUCTION SCALE FROM EARLY
DEVELOPMENT Consider environmental, safety and
economical issues Use well established techniques
easy to explain toauthorities (and the buyer
of the process) Design for low bio burden
(Selection of buffers and CIP) Availability of
raw material in large quantities Include
production of stabile intermediate
product Cleanability of equipment The validation
task in production scale
30

Contract Manufacturing Organization (CMO)
Provider of mammalian and microbial based
contract services including development and
manufacture
Cloning transfection
Fermentation/Cultivation
Recovery
Purification and API formulation
Analytical development and QC
Quality Assurance and Regulatory Support
State-of-the-art new facility designed and
constructed from green-field for flexible CMO
services

31
Choosing a CMO

Focus on
Time, money and competence
Drawback
Loss of control of the manufacturing process, is
the quality level OK?, IP exclusivity
Dependent on the CMO for your success better
choose wisely (quality, science, ease of scope
changes, avoidance of mouse-trapping).
Benefits
Lack of in-house capacity
Avoid capital risk to build facility postpone
investment
Reduction of overhead costs, economy of scale
Access to CMOs capacity, expertise (toolbox),
experience and flexibility saving internal
resources for other activites
CMO typically masters many different technologies
cost-efficiently
Complex biotech processes avoid the learning
curve and how to deal with regulatory bodies
Established companies
Leveraging bottlenecks in capacity for
development and manufacturing and acces to new
technologies
Newly established biotech
Lack of technology, CGMP and regulatory
competencies and/or financial muscle for
financing own factory