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• 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, UKMay 15 2014
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
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
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 IndiaAn 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/
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
Bioproduction Models1/3
Single Use in production are pre-fabricated Units
Set up of a 50L Bioreactor Single Use
Bioproduction Models2/3
CIP - SIP
50L Bio Stainless Steel
Bioproduction Models3/3
Regulatory Inspections
Inspectional Observations CDERCitations review
«Retrain is not doing better»
FDA White Paper: March 2011
How To Reduce Human Error By Managing Human Factors White Paper
2006 2007 2008 2009 2010 2011 2012 2013-2%
0%
2%
4%
6%
8%
10%
12%
14%
16%
0%
5%
10%
15%
20%
25%
30%
35%
Top 20: Training related
enforcements
Top 10: SOP related
enforcements
21 CFR 211.25(a) &(b)Personnel qualifications
21 CFR 211.100(a)&(b)Production and Process Controls21 CFR 211.67(b)Cleaning and Maintenance
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
Empowering Operations and Perfecting Compliance
Technical Knowledge Management
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
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
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
NDA
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
New training model: “Flip the Classroom”
Assign «Lectures» as Homework:
Watch contextualized operations prior to hands-on sessionsi. Start, Pause, Replay, without fearing interrupting ii. Free up Expert time
Hands-on sessions
i. Efficient vs time and costsii. Minimize risk on production lines
Optimize skill sets
i. Mentoring, ii. Learn by peer
Minimizing variability in process operations using knowledge management platform
Herman van HerkScientist USPVaccine Process and Analytical Development Archimedesweg 4-6PO Box 20482301 CA LeidenThe NetherlandsTel: +31 (0)71 519 9197Email: hvanher@its.jnj.com
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
Mediabooks platform
• Current platform:
7 applications with > 50 Mediabooks
Used across different sites within Crucell
Used for training of external parties as well
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
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!
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
Thank you
“Watch it and do it”
KNOWLEDGE BECOMES INFECTIOUS
Arnaud Schmutzwww.sourcin.com