• 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