Technology transfer from R & D to production in pharmaceutical industry

presentation on technology transfer in pharmaceutical industry

1. TECHNOLOGY TRANSFER Dhadwad Sagar Dashrath F.Y.M.Pharm 504 Dr.D.Y.Patil IPSR, pimpri Pharmaceutics Department Guided by: Dr. Satish Shirolkar

2. Contents Introduction Classification Steps in Technology Transfer Process Contents of Technology Transfer Technology Transfer Team Facets of Technology Transfer Factors Influencing Technology Transfer Cases/Examples of technology transfer Success of technology Transfer CONCLUSION

3. 1. Introduction According to WHO, Technology Transfer is a logical procedure that controls the transfer of any process together with its documentation and professional expertise between manufacture sites. Technology transfer is defined as the transfer of manufacturing process for a new pharmaceutical drug substance and drug product respectively, from the transferring site (in these case R&D) to receiving site or designated manufacturing site. It also refers to the processes of successful progress from drug discovery to product development, clinical trials and ultimately full scale commercialization.

4. It is both integral and critical to drug discovery &development process for new medicinal products. It is helpful to develop dosage forms in various ways as it provides efficiency in process,maintains quality of product , helps to achieve standardized process which facilitates cost effective production. Technology transfer is important for such research to materialize on a larger scale for commercialization especially in the case of developing product. Technology transfer includes not only patentable aspects of production but also includes the business processes such as knowledge and skills.

5. 1.1 Goal of technology transfer It is to transfer product and process knowledge between and manufacturing and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy process validation approach and ongoing continual improvement. 1.2 Objective of technology transfer To explain the processing information to transfer technology from R&D to production site by listing out information gathered during R&D. To explain the processing information to transfer technology of already existing drug product between various places .

6. 2. Classification Vertical technology transfer : It refers to the transfer of data from basic study to development and production respectively. Horizontal technology transfer : It refers to the movement and application of technology is to be used in one place or context to a different place

7. Technology developer (R&D Lab) Technology receiving site (process development lab) Feasibility study Scale-up Exhibit batches Stability study Process validation batches Production batches(Commercialization) Flowchart of Technology transfer in pharmaceutical industry

8. 3. Steps in Technology Transfer Process Development of technology by R&D [Research Phase] Pilot plant Technology transfer from R&D to production [Development Phase] Optimization and Production (Production Phase) Procedures and documentation of technology transfer F. Check & Approval

9. A. Development of technology by R&D [Research Phase] Design of procedure and selection of excipients by R&D. Identification of specification and quality by R&D.

10. B. Pilot plant Pilot plant: Lab scale formula is transformed into a viable product by development of reliable practical method of manufacture. Scale-up: the art of designing of prototype using the data obtained from the pilot plant model. The pilot plant plays a critical role in the technology evaluation, scale up and transfer activities of new products a properly designed and operated pilot plant can aid in the enhanced collection of scientific data necessary for the support of internal transfer activities as well as regulatory submissions. R&D Pilot scale Scale up Large scale production

11. B. Pilot plant Key technical aspects that must be addressed during scale-up in the pilot plant includes: Identification and control of critical component and formulation variables early in development Pilot plant equipment simulates as closely as possible to the equipment that will be used at the manufacturing site Identification of critical process parameters and operating ranges for the pilot plant equipment through the use of statistically designed experiments Collection of product and process data to adequately characterize each unit operation.

12. C . Technology transfer from R&D to production [Development Phase] Master Formula Card (MFC). The generic name, MFC number, page number, effective date, shelf life, and market. Master Packaging Card. Master Formula. Specifications and Standard Test Procedures (STPs).

13. D . Optimization and Production (Production Phase) Validation Studies Scale Up for Production

14. E . Procedures and documentation of technology transfer Research and development report Technology transfer documentation Product Specification file Technology transfer plan Technology transfer report Check and approval by Quality Assurance Department For implementation of technology transfer Manufacturing related documents including drug product standard Verification of results of technology transfer Points of concerns for post-marketing technology transfer

15. F. Check & Approval Production master formula Manufacturing instruction Dispensing instruction Analytical methods Previous process validation Stability report Excipients specification & source Active specification & source 9 . Primary packaging material specification & source 10. Packaging instruction 11. Customer complaints 12. Process deviation file 13. Analytical deviation file 14. Reject/Rework file 15. Specimen manufacturing batch record 16. Specimen cartons, labels

16. 4. Contents of Technology Transfer Proper Research Proper work pricing publicity partnership People’s acceptance 6P

17. 5.Technology transfer team Process technologist Central focus for transfer activity Collates documentation from donor site Perform initial assessment QA representative Review documentation to workout compliance wit market authorization Review analytical strategies with QC Initiates &confirms regulatory needs

18. c ) Production representative Review process instruction Considers any safety implication Considers training requirement Engineering representative Review production instrumentation requirement suggest requirement engineering modification Review preventive, maintain & calibration impact QC representative Review analytical requirement Availability with instrument Responsible for analytical technique transfer for drug substance and drug product

19. 6. Facets of Technology Transfer Government labs to the private sector Between the private sector firms of the same country From academia to private sector firms Academia, government and industry collaborations

20. 7.Factors Influencing Technology Transfer Drivers for Technology Transfer Barriers of Technology Transfer Approaches to overcome barriers in technology transfer

21. a) Drivers for Technology Transfer Good business and manufacturing practices Potential for competitive pricing Strategic planning Promising market scale and accessibility Adherence to regulatory standards Skilled workforce Innovation- friendly environment with sound Intellectual Property Protection and Enforcement Proper access to information or increased information exchange

22. a) Drivers for Technology Transfer Opportunities for contingency supply Access to new machinery, training, know-how and business partnership

23. b) Barriers of Technology Transfer Lack of awareness knowledge and efficiency Lack of government focus low market share Web access and scientific publication Cost of prequalification National security issues and restrictions on exports of particular technology Inadequate funding in important areas and possible treaties Labour issues

24. c) Approaches to overcome barriers in technology transfer Commercializing publicly funded technologies Political stability and good transparent governance Research tool patents and freedom to operate for the public sector Appropriate Capital Markets Co-operative research agreements

25. 8. Cases/Examples of technology transfer The Bhabha Atomic Research Centre (BARC) The National Chemical Laboratory (NCL) Pune Department of Biotech (DBT) Eli Lilly and company: has a technology transfer agreement with Shasun Chemicals and Drugs for the manufacturing of anti T.B drug CYCLOSERINE produced by Shasun to meet Eli Lily global demand. Center of disease control and prevention(CDC)- New Live Attenuated Vaccine Against All Four Types Of Dengue Infection.

26. 9. Success of technology Transfer The Communication: Open communication between all team members. The Direct communication between technical members. The effective and timely communication with regulators.

27. Team work, most of the time…….. Sending and Receiving Unit “ Technology transfer is not a one way street”. The sending & receiving unit must be equally involved in the process to ensure success. The Team work at all time.

28. 10. CONCLUSION The transfer involves cost and expenditure that is negotiated and agreed upon by the transferee and transferor. The transfer may be said to be successful if the transferee can successfully utilize the technology for business gains and eventually assimilate it. Appropriate efficiency in technology transfer from development to commercialization can be achieved through better communication and documentation by technology transfer team. Use of enriched approaches like technology transfer to the development and start-up of new production systems will enable pharmaceutical organizations to fully benefit from the recent improvements in the new drug discovery and to complete more effectively in a rapidly changing marketplace.

29. REFERENCES Shalini S, Nijanthan K, Rajkumar B, Muthukumar S, Sanka C and Arulkumaran G: An overview on technology transfer of pharmaceutical industry. Int J Pharm Sci & Res 2020; 11(2): 573-79. doi : 10.13040/IJPSR.0975-8232.11(2).573-79. Yogesh S. Waghmare and Sonali P. Mahaparale , THE IMPORTANT ROLE OF TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY-A REVIEW, World Journal of Pharmaceutical Research; Volume 6, Issue 9, 310-329 2017. Swapnil Nivrutti Misar , Akshaykumar Vinodrao Bhurghate , Jitendra Singh Sisodia, Somnath Kailas Gaikwad and Hitendra Brijlal Patil: Technology Transfer: A Paradigm for Industry. Int. J. Pure App. Biosci. 2 (2): 221-228 (2014). Popat B. Mohite* and Sachin V. Sangle:Technology transfer in pharmaceutical industry- A Review. International Journal of Advances in Pharmaceutics 2017; 06(01): 01-07. http://www.slideshare.net/polurikoteswari/pilot-plant-scale-up-techniques-1?from_m_app=android