Planning for a Successful CMO/Client
Relationship
Planning for a Successful
CMO/Client Relationship
• Agenda
– Background
– HollisterStier Capabilities
– What to consider when looking for a CMO
– What a CMO looks for
– Business details
– Project management
– Timing constraints for projects
1/1/07
Planning for a Successful
CMO/Client Relationship
1/1/07
Planning for a Successful
CMO/Client Relationship
• HollisterStier Capabilities
– Small Lot Manufacturing Area
- 30sqft lyophilizer
- ISO5 filling/capping
– Commercial Scale Filling Area (SVP)
- 2 x 200sqft lyophilizers
- Auto load/unload
- Cold shelf loading
- High speed filling line (300vpm)
- Second filling line Jan 2008 (400vpm)
- Inspection, labeling, packaging
– Support Services
- Analytical Chemistry, Microbiology
- Method Transfer and Validation
- ICH Stability
- Regulatory Affairs
1/1/07
Planning for a Successful
CMO/Client Relationship
• Before you start your search…….
– Know your requirements
- What services are needed
- Be specific
- Is process defined
- Has it been scaled up
- What testing (in process and final)
- Small scale vs large scale
- What is the desired timeline
1/1/07
Planning for a Successful
CMO/Client Relationship
• Looking for a CMO
– Where do you start
- Internet search
- Colleagues
- Advertisements
- Trade shows
– Considerations
- Geographical
- Needs vs CMO’s capabilities
- Corporate culture
- Change control systems
- Regulatory history/experience
- Cost and timing
1/1/07
Planning for a Successful
CMO/Client Relationship
• Confidentiality agreement (CDA)
– Individual product
– Open CDA
– 3 way CDA
• Data Acquisition
– Project Questionnaire
– Request for Proposal
– Technical Package
– Technical teleconference
– Site visit
1/1/07
Planning for a Successful
CMO/Client Relationship
• Why do CMOs ask for a Project Questionnaire
– Foundation for evaluation/discussion
– Lack of information slows evaluation process
– Provide as much information as you can
- Batch size, concentration, number of lots
- Product classification
- Cell line or animal derivative
- Small molecule pharmaceutical
- CBER or CDER or EMEA or ???
- Services
- Liquid or Lyophilized product fill
- Labeling/Inspection/Packaging
- Quality Control testing
· Incoming, in-process and final
· Method qualification or validation
- Stability/Retains
1/1/07
Planning for a Successful
CMO/Client Relationship
• Initial Project Scope Development
– Critical process parameters
– Vial, syringe, other
– Testing requirements
– Packaging requirements
– Miscellaneous support
- Regulatory
- Engineering
– Project timing
- How many lots
- Available facility and labor resources
1/1/07
Planning for a Successful
CMO/Client Relationship
• CMOs Evaluate Clients too
– Primary Criteria
- Product classification
- Regulatory issues
- MSDS/HES
- Phase of product
- Good fit in core capabilities
- Components
- Level of support vs available resources
– Secondary Criteria
- Completeness
- Willingness & ability to provide information
- Follow through
- Company compatibility
1/1/07
Planning for a Successful
CMO/Client Relationship
• Risk Analysis
– Definition of Risk
- How something or someone will impact the
facility, staff and/or their regulatory status
- Effect that will have on current and future
clients
• Develop a Quote
– List assumptions
– Departmental requirements
- QU, Manufacturing, Validation, Engineering
– List deliverables
– General timing
– Pricing
1/1/07
Planning for a Successful
CMO/Client Relationship
• Business Agreements
– Verbal agreements
– Letter of Intent (LOI)
– Signed proposal/quote
– Development agreement
– Supply agreement
– Project agreement
• Documents take time to finalize
– Avoid problems in future
– Cancellation fees
– Payment terms
• Quality Audit
– Learn CMO’s quality, documentation & CAPA
systems
– Utilize auditors with project/product knowledge
1/1/07
Planning for a Successful
CMO/Client Relationship
• Project Management
– Project Leader
– Cross functional teams
– Accountability
– Decision makers
• Kick off Meeting
– Finalize scope
– Develop project timeline
• Routine Meetings
– Frequency
– Agendas/minutes
– Separate and joint meetings
1/1/07
Planning for a Successful
CMO/Client Relationship
• Control the Scope
– Finalized in kick off meeting
– Communicate through project schedule
– Avoid mid course changes
– Additive impact of scope creep
– Customized requirements extend project and
increase costs
– Balance the needs of both parties
1/1/07
Planning for a Successful
CMO/Client Relationship
• Consistency
– Define and harmonize terminology
– Intent is more important than style
– Use CMOs documentation and Quality systems
• Method Transfer
– Transfer, qualification, validation
– Provide validation package if at all possible
– Identity test requirements
– Use caution with non GMP third party labs
– Link transfer to date of manufacture
1/1/07
Planning for a Successful CMO/Client
Relationship
• Regulatory
– Viral clearance policies
– Level of involvement in developing CMC
– Adequate time for document review
– Product responsibility belongs to Client
– PAI inspection reports belong to CMO
– Shared approach wins the day
1/1/07
Planning for a Successful
CMO/Client Relationship
• Timing constraints
– Limitations to resources
- Both by CMO and Client
- Time in queue to kick off
– Ordering of equipment and supplies
- CMO doesn’t have endless inventory
- Dedicated tanks, filling pumps, etc
- Up to 20 weeks
- Components (vials, stoppers, seals)
- Minimum order quantities
- Up to 24 weeks
1/1/07
Planning for a Successful
CMO/Client Relationship
1/1/07