- Sourcin provides operating instructions and multimedia content for knowledge transfer in biopharma and medtech. - The presentation discusses technology transfer challenges like language barriers, the need for intensive and repeated training, and ensuring expertise is retained locally. - Sourcin addresses these challenges through its Mediabook platform which uses video and visuals to document processes in a language-free way for training and standardization. The platform can be used for on-the-job training and minimizing variability in operations.

1. • Incorporated in 2011 Fribourg Switzerland
• Market: Operating Instructions – Production
• Sectors Biopharma, Medtech
• Unique blend of expertise
• Engineering
• Multimedia,
• Web portal
• Video
High Value Product Technology Transfer Conference 2014 Durham, UK
May 15 2014

2. Agenda
• Technologies Transfer
– Definition
– Review of experiences
• Examples of Actual Technologies to Transfer
• Learn from Existing Inspections Track Records
• Assist Knowledge Transfer
• Case study
• Support Tech Transfer Till Handover
• Conclusion

3. What is Technology Transfer?¹
• Transfer of Technology (TOT), is the process of transferring skills,
knowledge, technologies, methods of manufacturing, samples of
manufacturing and facilities …..It is closely related to (and may
arguably be considered a subset of) knowledge transfer.
Horizontal Transfer is the movement of technologies from one area
to another.
• Transfer of Technology (TOT) is primarily horizontal. Vertical
Transfer is when technologies are moved from applied research
centers to research and development departments.
[1] Excerpts from http://en.wikipedia.org/wiki/Technology_transfer

4. Speaking by experience
• Relevant Findings:
“…Over 90% of vaccines are produced by less than 15 manufacturers, and over 80% of vaccines are
produced in LMICs (compared with only 7% of drugs).” - Dr. Wenfeng Gong -
• NVI (Nederland Vaccin Instituut) high requirement for technical know-how :
– Production,
– Quality Control,
– QA Regulatory
• referring to Amie Batson and Julie B. Milstien - Health Affairs 27, no. 1 (2008): 140–142; 10.1377/ hlthaff.27.1.140
• Jean-Marie Préaud JAPANESE ENCEPHALITIS project :“Capacity building” in China.
“…It takes a long time for training and implementing Quality Management Systems…”
– Language barrier leading to misinterpretation of documents.
– Training have to be repeated to make sure that lessons are understood correctly.
• Michel BAIJOT: FIOCRUZ – GSK:
– Develop people by training and empowerment
– Learning by doing and the learning curve: The recipient of technology must adapt a “do-it “ attitude
• Jean-Marie Préaud: Development of MenAfriVac™ in India
An example of efficient technology transfer to develop a needed vaccine
– communication was the key to the success of this project
Workshop on Technology Transfer WHO HQ –
Geneva, November 30th – December 1st, 2010.
http://www.who.int/phi/news/workshop_tt_vaccines2010/en/

5. Considerations
• Technologies to Transfer
– Production,
– Quality Control,
– QA Regulatory
• Expertise implies
– Versatile Activities
– Broad Skill Sets
– Logistic
• Intensive Training activities
– Language Barrier
– Learning by doing
• Costs

6. Bioproduction Models 1/3
Single Use in production are pre-fabricated Units

7. Set up of a 50L Bioreactor Single Use
Bioproduction Models 2/3

8. CIP - SIP
50L Bio Stainless Steel
Bioproduction Models 3/3

9. Regulatory Inspections

10. Inspectional Observations CDER
Citations review
«Retrain is not doing better»
FDA White Paper: March 2011
How To Reduce Human Error By Managing Human Factors White Paper
0%
5%
10%
15%
20%
25%
30%
35%
0%
2%
4%
6%
8%
10%
12%
14%
16%
2006 2007 2008 2009 2010 2011 2012 2013
21 CFR 211.25(a) &(b)
Personnel qualifications
21 CFR 211.100(a)&(b)
Production and Process Controls
21 CFR 211.67(b)
Cleaning and Maintenance

11. Metrics?
Measuring Training Effectiveness
• Ensure training translate into less deviation and more efficient
processes (performance)
Improving SOP and Policy Management
• Ensure the instructions pertained in SOPs are fully understood and
performed on a daily basis?
By Asking ourselves:
• Was the procedure adequate and able to be followed?
• Did training prepare the person to perform the task?
• Was Operating procedures Aligned to the Shop-floor
Human Error Is The Leading Cause Of GMP Deviations – Or Is It?
Joanna Gallant

12. Empowering Operations and Perfecting Compliance
Technical Knowledge Management

13. Content preparation & diffusion
Operations: Mediabooks
• Prepare instructions
• Visual - Language Free
• Dedicated Reference
Organize Information: Diffusion
• Libraries:
Mediabooks, Documents, Forum & Quiz
• Collaborative environment
Secured connection, id, pw profiles
• On-The-Job, Training
• Share

14. Learning pathway
Knowledge definition*
The psychological result of perception,
learning and reasoning
• Something you have observed
• That you have interpreted and stored
• That you can apply to future situations
*Webster

15. How we work: Tandem w/ SME
Storyboard
• Transfer the full actual instructions into a synopsis of operations
• Customer project team approval
Capture
• Video capture on-site
• Selection of key steps
Project
• Create Customer Platform
• Organize the procedure relevant information
• Deliver Draft Mediabooks
Libraries
• Released Final Mediabooks
• SOPs, Specimens, Warnings & Symbols Publishing
• Simplifying update and revision exercise

16. How is it used during a ToT ?
?
Coordination
– Proactively “export” Tech context
– Leverage from the ToT stakeholders
– Ensure to capture adequate practical knowledge
– Build up a Repository of Knowledge
– Secure Start up Phase
Minimize Variability
– On-the-job assistance
• Contribute to standardization
– Staff training management
• Secure know-how in-house
• Prevent skillsets loss

17. New training model: “Flip the Classroom”
Assign «Lectures» as Homework:
Watch contextualized operations prior to hands-on sessions
i. Start, Pause, Replay, without fearing interrupting
ii. Free up Expert time
Hands-on sessions
i. Efficient vs time and costs
ii. Minimize risk on production lines
Optimize skill sets
i. Mentoring,
ii. Learn by peer

18. Minimizing variability in process operations
using knowledge management platform
Herman van Herk
Scientist USP
Vaccine Process and Analytical Development
Archimedesweg 4-6
PO Box 2048
2301 CA Leiden
The Netherlands
Tel: +31 (0)71 519 9197
Email: hvanher@its.jnj.com

19. Leiden
-USP
-Valerio
Bern
-Cell & virus banking
-USP
-Process characterization
Solna
Springhouse
External
-Licensees
-Partners
Key elements:
-Training
-Standardized Operation
Knowledge transfer for USP processes

20. Mediabooks platform
• Current platform:
7 applications with > 50 Mediabooks
Used across different sites within Crucell
Used for training of external parties as well

21. Conclusion
• Mediabooks tools help to:
• Share: Learn from each other and analyze
• Show what cannot be written
• Train by reviewing key steps at its own pace
For Crucell, it is a strong tool for both training and
standardization of USP processes

22. Support Tech Transfer till handover
1. Capitalize from the high concentration of
knowledge during the TOT project
2. Training: Classrooms – Hands-on
The devil is in the detail: catch it and share it!
3. Resources and time:
– Experts and project members availability
4. Ensure continuity in communication
– Mentoring & Learn-by-peers
– On-the-Job : routine dexterity
5. Back to the roots!

24. Conclusion
Knowledge Transfer:
Reference Tutorials
Efficient, secured of mean documenting
process key operating features
Coordination
Fostering a seamless, contextual practical knowledge
Securing relevant skill sets in routine manufacturing
processes on the receiving end
Transferrable
Build your Thesaurus
Share it proactively
Plan training early

26. Thank you
KNOWLEDGE BECOMES INFECTIOUS
Arnaud Schmutz
www.sourcin.com