Technology transfer

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 – Process Technology 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 – Process Technology 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 – Process Technology 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 – Process Technology 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 – Process Technology 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