Overførsel af teknologi og viden fra udvikling til produktion er ofte meget kompliceret og forbundet med forsinkelser og uventede omkostninger. Kom og se, hvordan Johnson & Johnson, som er en af de helt store spillere inden for pharma branchen, bruger smarte værktøjer udviklet af NNE Pharmaplan på dette område.

1. BRUG SMARTE
VÆRKTØJER TIL
TEKNOLOGI-
OVERFØRSEL
PF2P
Leif Poulsen
1

2. Tech Transfer Characteristics
2
“The goal of technology transfer activities is to transfer product and
process knowledge between development and manufacturing, and
within or between manufacturing sites to achieve product
realization. This knowledge forms the basis for the manufacturing
process, control strategy, process validation approach, and ongoing
continual improvement” (ICH Q10 Paragraph 3.1.2)
Laboratory
Development/
Pilot scale
Development
Clinical
Manufacturing
Development
Launch/
Commercial Mfg
Technology
Product
Process
Equipment
Automation
Procedures
Training
Development
Third Party
Manufacturer
Site A
Manufacturing
Site B
Manufacturing
Sending Unit Receiving Unit

3. Tech Transfer Challenges
3
• Complex process
• Various level of knowledge
• Gaps in knowledge
• Lack of methodology
• Lack of guidance
• Many mistakes
• Budget overruns
• Significant delays
Sending Unit
Typical
Ideal
Receiving Unit

4. ISPE Good Practice Guide
4
Technology Transfer
Project Model
Transfer of
Knowledge
for Analytical
Procedures
Drug
Substance
Technology
Transfer
Drug Product
Technology
Transfer

5. Tech Transfer Project Model
5
• Develop TT
charter
• Form TT team
• Involve TT Stake
holders
• Develop TT
Proposal
• Consolidate TT
knowledge
• Define TT
Package
• Assess risks
• Identify gaps
• Assess
mitigations
• Develop TT plan
• Modify Facility
• Install & modify
Equipment
• Perform test runs
• Prepare
documentation
• Train people
Setup
Charter &
Organisation
Develop
Proposal &
Package
Assess Risk
Identify Gaps
Make Plan
Execute
Plan
1 2 3 4
• Develop
qualification
protocols
• Execute
qualification
activities
• Review
qualification
results
• Transfer
ownership and
closure
• Support of
regulatory
activities
• Compile lessons
learned
Qualify
Process/
Procedure
Handover
Technology
5 6
Project Initiation
Project
Delivery
Planning
Project Implementation
Project Close
Out

6. PF2P – Process Fit to Plant
6
• A methodology that help a cross-functional team identify and develop the design, the
creation and continued operations of a process/project ‘right first time’.

7. PF2P What we need
• Need to have tools guidance knowledge and pragmatic guidance/instructions
• Ensure all parties contribute their knowledge
• We want to give the right people the right tools and practices.
• Not checklists, SOPs etc.
• So how do we do that?
• Integration of people knowledge and best practices…..
7

8. PF2P Three Major Elements
8
Practices
Common sense work
procedures that consistently
prompt the “right” discussions
and actions of the project team,
and not ‘checklist behavior’
Tool
Visual, intuitive guide to
lead users through process;
data collection and
knowledge management
center
People
Process experts, experienced engineers,
and user community to execute, sustain and support the process.

9. PF2P Cross-Functional Team
9
• Ensures process design and transfer is successful.
• Build cross-functional collaboration in design, review, and execution activities.
• Common sense science & engineering discussions make sure all aspects are
covered – “no magic”.
• Practices and Wiki help lead execution & support the process – team has the
expertise.

10. PF2P Activities
10
Project
Tech Transfer &
Design
Construction &
Commissioning
Ongoing
Production

11. PF2P In Action
11

12. PF2P Tools Example
12
Demo

13. Questions
13