Pharmaceutical contract manufacturing challenges ISPE Central Canada Chapter Annual Meeting

Pharmaceutical contract
manufacturing challenges
ISPE Central Canada Chapter
Annual Meeting
September 28, 2006
Yvon R. Tessier
Outline
• Traditional positioning of the CMO’s
• New trend in Contract Manufacturing
• Challenges
– Opportunities
– Threats
• Can we make the difference?
• Q&A
Traditional positioning of the CMO
“Not so long ago, big pharmaceutical
companies turned to CMOs solely to
supply:
• cost efficiencies
• capacity
• time-to-market
• expertise not available in-house”
Source: Pharmaceutical Technology, Feb, 2004 by Doreen R. Coppola
Product Life Cycle Curve
Time to
market
Capacity
Cost
Traditional relationship
Pharmaceutical Cie.
• Owns the know-how
• Manages technology
transfer
• Needs short term
capacity:
– Unexpected sales
– Launch quantities
– Limit risk on new
technologies
Contract Manufacturer
• Limited know-how
• Minimum involvement
in transfer
• Provides manufacturing
capacity:
– Equipment
– Labour
– Specific technology
New trend in Contract
Manufacturing
“Companies are outsourcing to
concentrate on marketing their
products”
“Spending less time in drug discovery
and manufacturing”
“Virtual companies exist by the simple
fact that they can rely on the contract
manufacturers and researchers”
Source: RB-203 Pharmaceutical Contract Manufacturing and Research,
BUSINESS COMMUNICATIONS COMPANY, INC
Published: April 2005
New business model
Contract
Formulator
CRO
Innovator
(Virtual
company)
Regulatory
Consultant
Contract
Analytical
Laboratory
CMO *
Marketing
Partner
* Note: Some CMO’s offer more than one service such as formulation,
analytical and regulatory expertise
►
Challenges
Opportunities
Threats
Opportunities
“Worldwide revenue for contract
manufacturing and research for the
pharmaceutical industry was estimated at
$100 billion in 2004 and is expected to rise
at an average annual growth rate of
10.8% to $168 billion in 2009”
Source: RB-203 Pharmaceutical Contract Manufacturing and Research,
BUSINESS COMMUNICATIONS COMPANY, INC
Published: April 2005
Opportunities
World-Wide Revenue of Contract Manufacturing and Contract
Research Organizations, 2002-2004 and 2009
($ Billions)
Source: RB-203 Pharmaceutical Contract Manufacturing and Research,
BUSINESS COMMUNICATIONS COMPANY, INC
Published: April 2005
Threats
• Emerging countries like India and soon
China will provide low cost products that
will meet cGMP’s
• The old business model will not sustain
growth for North American CMO’s
• The new business model is more complex
and requires different skills
Product Life Cycle Curve
•Time to market
•Technology available
•Technical expertise
•Proximity
•Quick reaction
•Proven quality system
•High
capacity
•Low
cost
•Low
cost
Can we make the difference?
The battle will be fought on the technical field:
• Technological Challenge
• Latest technology ?
• Scalable process equipment
• Validation
• Compliance to cGMP’s
• Documentation
• Project management
• Don’t forget SHE !
Technological challenges
• The need to keep pace with nextgeneration process technology becomes
more challenging.
• In the case of many emerging
pharmaceutical products, the challenge is
to make viable commercial production
possible at all.
• COM’s need to invest in technology and
people
Latest technology ?
• We need to stay aware of new technology
development
• Sometimes old technology is the best
option…
• Staff from R&D, Validation, Production and
Maintenance must be trained and have as
much exposure to information about new
technology as possible
Scalable process equipment
• New business often starts at lab or pilot
scale
• Clients prefer to scale-up without having to
change manufacturing site
• Equipment selection can improve chances
of attracting new business
Validation
• The need for small scale cGMP batches
has increased so R&D equipment needs
to be qualified (IQ/OQ).
• Cleaning validation is one of the biggest
challenges for a CMO since dedicating
equipment is not economical.
• Change control procedures must be
closely followed.
Compliance to cGMP’s
• Most clients intend to market product
world wide
• Quality system must meet regulation in
multiple markets plus clients internal
standards
• Other clients rely on CMO’s quality system
since they don’t have internal resources
Documentation
• New projects start at pre-clinical stage
• Process is improved along the way
• Batches are made for development, scaleup, stability, clinical trials and process
validation
• PAI may occur years later
• Good documentation practices must be
followed at all times (even if clients do not
request it explicitly)
Project management
• New projects involve many organisations
• All functions from all partners will get
involved at one time or an other
• Project scope will evolve and scope
changes must be managed carefully
• CMO’s are becoming technical expertise
providers and they must behave
accordingly
Don’t forget SHE !
Safety Health and Environment must always be
kept in mind:
• Clients may outsource hazardous processes
• Large firms have very strict SHE requirements
• The hazards of handling multiple processes
involving new chemicals must be evaluated
• New drugs are more and more potent
“No one can afford a serious SHE incident”
In conclusion
• Contract Manufacturing Organisations will
have to adapt to a new business
environment
• Successful CMO’s will be the ones with
the strongest technical staff capable of
participating in multidisciplinary project
teams
• ISPE members will benefit from those
opportunities
Questions ?
Comments ?
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