The document discusses technology transfer in the pharmaceutical industry. It defines technology transfer as the process of transferring manufacturing knowledge from research and development sites to production sites. The key steps in the technology transfer process are developing the technology in R&D, pilot plant studies, transferring technology from R&D to production, optimization and production, documentation, and approval. Successful technology transfer requires effective communication and teamwork between the sending and receiving sites.
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Technology transfer from R & D to production 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
1) Introduction
2) Classification
3) Steps in Technology Transfer Process
4) Contents of Technology Transfer
5) Technology Transfer Team
6) Facets of Technology Transfer
7) Factors Influencing Technology Transfer
8) Cases/Examples of technology transfer
9) Success of technology Transfer
10) 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
i. Vertical technology transfer : It refers to the transfer of data from
basic study to development and production respectively.
ii. 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
A. Development of technology by R&D [Research Phase]
B. Pilot plant
C. Technology transfer from R&D to production [Development Phase]
D. Optimization and Production (Production Phase)
E. Procedures and documentation of technology transfer
F. F. Check & Approval
9. A. Development of technology by R&D
[Research Phase]
a) Design of procedure and selection of excipients by R&D.
b) 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:
i. Identification and control of critical component and formulation
variables early in development
ii. Pilot plant equipment simulates as closely as possible to the equipment
that will be used at the manufacturing site
iii. Identification of critical process parameters and operating ranges for
the pilot plant equipment through the use of statistically designed
experiments
iv. Collection of product and process data to adequately characterize each
unit operation.
12. C . Technology transfer from R&D to
production [Development Phase]
a) Master Formula Card (MFC).
b) The generic name, MFC number, page number, effective date, shelf life,
and market.
c) Master Packaging Card.
d) Master Formula.
e) Specifications and Standard Test Procedures (STPs).
13. D . Optimization and Production
(Production Phase)
a) Validation Studies
b) Scale Up for Production
14. E . Procedures and documentation of
technology transfer
a) Research and development report
b) Technology transfer documentation
c) Product Specification file
d) Technology transfer plan
e) Technology transfer report
f) Check and approval by Quality Assurance Department
g) For implementation of technology transfer
h) Manufacturing related documents including drug product standard
i) Verification of results of technology transfer
j) Points of concerns for post-marketing technology transfer
15. F. Check & Approval
1. Production master formula
2. Manufacturing instruction
3. Dispensing instruction
4. Analytical methods
5. Previous process validation
6. Stability report
7. Excipients specification &
source
8. 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
publicit
y
partnershi
p
People’s
acceptanc
e
6P
17. 5.Technology transfer team
a) Process technologist
Central focus for transfer activity
Collates documentation from donor site
Perform initial assessment
b) 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
d) Engineering representative
• Review production instrumentation requirement
• suggest requirement engineering modification
• Review preventive, maintain & calibration impact
e) 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
a) Drivers for Technology Transfer
b) Barriers of Technology Transfer
c) 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;
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