Technology Transfer OSD

1. Technology Transfer
Introduction and Overview
Subhankar Das

2. Why Technology Transfer
Basic Concepts
on How and When
Success Criteria
Thoughts on Keys to Success
1
4
2
3

3. What is Technology Transfer
It is a systemic procedure that guides the transfer of any
product together with its documentation and professional
expertise between development and manufacturer or
between manufacturing sites.
In the pharmaceutical industry, “technology transfer”
refers to the processes that are needed for successful
progress from drug discovery to product development to
clinical trials to full-scale commercialization or it is the
process by which a developer of technology makes its
technology available to commercial partner that will
exploit the technology.

4. Stages in the Development of a New Medicine
Research Target
Biological Evaluation
4 –10 years
Discovery
Formulation
Development
Exploratory
Development
3+ years
Regulatory
Development
3+ years
Commercialization
3+ years
Integrated
Research
Process
Development Manufacturing
Candidate Drug
Formulation
Patents
Phase I - Clinical Trials
Phase II - Clinical Trials
Phase III - Clinical Trials
Registration
Launch
Sales
Build/Select API
Manufacturing
Facilities
Built/Select
Manufacturing
Facilities
Why Technology Transfer

5. Why Technology Transfer
When does technology transfer occur?
 Idea to Discovery Lab
 Discovery Lab to Development Lab
 Development Lab to Pilot Plant
 Kilo Lab to Pilot Plant
 Pilot Plant to Semi-works (other pilot plant)
 Pilot Plant/ Semi-works to Manufacturing
 Manufacturing to Manufacturing

6. Why Technology Transfer
Technology Transfer Importance to Industry
The importance of technology transfer are:
To explain necessary information to transfer technology from R&D to
actual manufacturing by sorting out various information obtained during
R&D; To explain necessary information to transfer technology of
existing products between various manufacturing places.

7. Why Technology Transfer
Technology Transfer Importance to Industry
 Appropriate transfer of manufacturing technologies (technology
transfer) is important to upgrade drug quality as designed during R&D to
be final product during manufacture as well as assure stable quality
transferred for many reasons between contract giver and contract
acceptor during manufacture.
 Technology Transfer is a important time for
companies
• Loss of knowledge or experience, leading to “reinvention
of the wheel”
• Confused ownership and responsibilities
• Delayed approvals

8. Stakeholders in the Quest for Effective Technology Transfer
Industry
 R&D
 Commercial
Stakeholders
Regulators
Customers
 Patients
 Healthcare providers
 The public

9. Stakeholders in the Quest for Effective Technology Transfer
Regulators’ roles:
Protect public health
Standardize regulations
Ensure safe, pure, and effective drug products
Drug approvals
Affect healthcare system
Facilitate and regulate, bringing new, more effective products to
market faster
Reduce the cost of healthcare

10. Stakeholders in the Quest for Effective Technology Transfer
Industry’s role:
Innovative R&D
Develop new, more effective compounds, delivery systems,
and medical devices
Compliant and effective commercialization
Ensure safe, pure, and effective drug products
Consistent interpretation of GMP regulations
Bringing new, more effective products to market faster
Adherence to all applicable regulations and guidelines
Cost-effective production and distribution
Superior return on investment to shareholders / stakeholders

11. Stakeholders in the Quest for Effective Technology Transfer
Customers & Patients:
• Safe and effective treatments
• New, more effective products to market faster
• Affordable healthcare cost

12. Transfer – ProcessTechnology
Phases of Technology Transfer
The processes are classified into the three categories.
Research Phase
Development Phase
Production Phase
1. Research Phase:
1.1 Quality Design : For Drug Products, the quality design corresponds to
so call pharmaceuticals design-to-design properties and functions such as
elimination of adverse reactions, improvement of efficacy, and assurance of
stability during distribution, and adding usefulness based on various data
such as chemical and physical properties, efficacy, safety and stability
obtained form preclinical studies.
For drug substance, the quality design is to determine starting materials and
their reaction paths, and basic specification of the drug.

13. Transfer – ProcessTechnology
Phases of Technology Transfer
2. Development Phase
2.1 Research for Factory Production:
To manufacture drugs with qualities as designed, it is required to establish
appropriate quality control method and manufacturing method, after
detecting variability factors to secure stable quality in the scale-up validation
that is performed to realize factory production of drug designed on the basis
of result from small-scale experiments.
2.2 Consistency between Quality and Specification:
When product specification is established on the basis of the quality of
product determined in the above, it is required to verify that the specification
adequately specifies the product quality.
In short, the consistency between quality and specification is to ensure in the
products specification that the quality predetermined in the quality design is
assured as the manufacture quality, and the product satisfies the quality of
design.

14. Transfer – ProcessTechnology
Phases of Technology Transfer
2.3 Assurance of consistency through development and
manufacturing:
To make developed product have indications as predetermined in clinical
phases, the quality of design should be reproducible as the quality of
product (assurance of consistency).
For this purpose, the transferring party in charge of development should fully
understand what kind of technical information is required by the transferred
party in charge of manufacturing, and should establish an appropriate
evaluation method to determine whether a drug to be manufactured meets
the quality of design.
2.4 Technology Transfer from R&D to Production:
Transfer of the technical information is necessary to realize manufacturing
formula established in the above in the actual production facility. Technical
information to be transfer should be compiled as R&D report.

15. Transfer – ProcessTechnology
Phases of Technology Transfer
3. Production Phase
3.1. Validation & Production:
While the manufacturing facility accepting technology is responsible for
validation, the research and development department transferring
technology should take responsibility for validation such as performance
qualification, cleaning validation, and process validation unique to subject
drugs.

16. Transfer – ProcessTechnology
Phases of Technology Transfer
3.2. Feed back from Production and Technology Transfer of Marketed
Products:
Technical information of developed products are obtained from data of a
limited amount of batches, various standards have been established from
the limited data, and quality evaluation method established in development
phase in not always sufficient for factory production, it is highly desired to
feed back and accumulate technical information obtained from repeated
production, if necessary. In addition, it is important to appropriately modify
various standards established before based on this information, and
accountability and responsibility for design and manufacturing should be
executed.

17. Knowledge Transfer Process
Need an effective transfer
process that plugs the
leaks
and yields better retention
Technology Transfer - How and When

18. “I think you need a few more
details here in the Transfer protocol”
R&D
Processes...
Commercial
Operations ...
Then a miracle occurs ...

19. Technology Transfer - How and When
Technology Transfer Guide is designed to:
• Present standardized process
• Recommend minimal base of documentation to support the
technical transfer process
• Define key terms and consistent interpretation
• Facilitate timely and cost effective technology transfers
• Consider regional requirements of US, Europe and Asia

20. Technology Transfer Task
Technology Transfer - How and When

21. Technology Transfer Success Criteria
Success Criteria?
"You can tell pharmacy we finally have
three batches of on-spec product."

22. Technology Transfer Success Criteria
What Constitutes A Successful
Technology Transfer?*
Success criteria from Definition of Technology Transfer:
“Technology transfer can be considered successful if a
Receiving Unit can routinely reproduce the transferred
product, process or method against a predefined set of
specifications as agreed with a Sending Unit and/or a
Development Unit.”
*From ISPE Technology Transfer Guide

23. Technology Transfer Success Criteria
There Is More To Successful
Technology Transfer:
Technology Transfer must also be completed:
• Safely
• The process being transferred runs as
expected (yield, purity, cycle time, etc.)
• On time (product launch)
• On budget
• No “CRISIS” situations

24. Technology Transfer Success Criteria
Critical Success Factors
Post Approval:
• Change Control
• Audit process performance
• Statistical review
• Continual process improvement program
• Statistical process control

25. Technology Transfer Success Criteria
If technology transfer isn’t done right...
• Process validation may be unsuccessful
• Delayed regulatory approval and/or product
launch
• faulty processing may result
• High rate of batch rejections, costly schedule revisions,
excessive labor requirements
• Analytical methods cannot support production
• Incomplete documentation
• Product does not perform as intended!

26. Keys to Success
What Is the Key to Successful Knowledge Transfer?
It Must Be Understood and Managed
by ALL Stakeholders

27. Keys to Success
Communication
• Open communication
between all team
members
• Direct communication
between technical
members
• Effective and timely
communication with
regulators

28. Technology Transfer Success Criteria
Sending and Receiving Unit
 Technology transfer
is not a “one way
street”.
 The sending unit
and
receiving unit must be
equally involved in
the process to ensure
success.
Formulation
Development
Process
Development
Technical
Services
Analytical
Development
Production
Quality
Control

29. Team work, most of the time
Technology Transfer Success Criteria

30. Thank You