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CURRENT ASPECTS OF
TECHNOLOGY TRANSFER IN
PHARMACEUTICAL INDUSTRY
PREPARED BY- SAYAN MAHAPATRA
M.PHARM ( QUALITY ASSURANCE)
ROLL NO-07
UNDER THE GUIDANCE
OF
Dr. JEYA PRAKASH M. R
CONTENTS
■ INTRODUCTION
■ THE IMPORTANCES OF TECHNOLOGY TRANSFER
■ REASON FOR TECHNOLOGY TRANSFER
■ FACTOR AFFECTING THE SUCCESS OF TECHNOLOGY TRANSFER
■ LIFE CYCLE APPROACH
■ TECHNOLOGY TRANSFER PROCESS
■ STEPS INVOLVED IN TECHNOLOGY TRANSFER
■ TECHNOLOGY TRANSFER TEAM
■ TECHNOLOGY TRANSFER DOCUMENTATION
■ IMPLEMENTATION OF TECHNOLOGY TRANSFER
■ VERIFICATION OF RESULT OF TECHNOLOGY TRANSFER
■ CONCLUSION
■ REFERENCES
INTRODUCTION
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.
THE IMPORTANCE OF TECHNOLOGY TRANSFER ARE:-
• * To elucidate necessary information to transfer technology from R&D to actual manufacturing by sorting out
various information obtained during R&D.
• * To elucidate necessary information to transfer technology of existing products between various manufacturing
places.
• * To exemplify specific procedures and points of concern for the two types of technology transfer in the above to
contribute to smooth technology transfer. This is applicable to the technology transfer through R&D and
production of drug and the technology transfer related to post-marketing changes in manufacturing places.
• Various stages of formulation development were as follows
1. Preformulation studies.
2. Bench scale - (1/1000th of X)
3. Lab scale - (1/100th of X)
4. Scale up- (1/10th of X or 0.1M whichever is maximum)
5. Commercial (X)
Where X is the final commercial scale batch size.
REASON FOR TECHNOLOGY TRANSFER :-
Lack of Manufacturing Capacity: the developer of the technology could solely
have to produce instrumentation that appropriates for lab and small scale operations
and should partner with another organization to try to do massive scale
manufacturing.
Lack of Resources to Launch Product Commercially: The original inventor of
technology may only have resources to conduct early stages research and phase - I
and II clinical trials.
Lack of Marketing Distribution and Distribution Capability: The developer of the
technology could have absolutely developed technology and even have obtained
regulative approvals and product registration, but it may not have the marketing and
distribution channels and should collaborate within another organization that has the
capability.
FACTORS AFFECTING THE SUCCESS OF
TECHNOLOGY TRANSFER:-
• Unlike the greenfield R & D project, the technology transfer is the importation of a developed R & D
product from outside the company. Therefore, a complete background of technology with it's possible
strengths & weaknesses need to be understood in the beginning.
• Issues related to costs, royalty, royalty payment, milestone payments need to be considered before the
technology transfer is to be opted. If this due diligence is not done correctly, the project may loose it's
priority within the company.
• Regulatory issues including 'difficult to resolve' issues need to be correctly addressed while the project
is on.
• Accurate calculations of time-lines with enough margins for development/ scale-up related issues,
country of licencing, regulatory guidelines existing in the country of origin, need to be taken into
account
• Lastly, the major factor is a team which accepts the technology & the team that offers the technology
should have complete understanding of the entire project & needs to develop a personal report besides
official project structure.
LIFE CYCLE APPROACH:-
1. The relevant stage of the life cycle of the facility,
equipment, instrument, utility, product, process or
procedure to be transferred should be taken into
consideration when the transfer is planned and
executed. This also applies to the control strategy and
process validation.
2. The responsible entities should monitor the progress of
the project at each applicable stage of the life cycle
aspect of the transfer to ensure a successful
completion of the transfer.
TECHNOLOGY TRANSFER PROCESS:-
Technology transfer is both integral and critical to the drug discovery and development
process for new medicinal products. The decision to transfer products between
manufacturing sites is frequently driven by economics. Key stages of the process include
data collection, data review, regulatory impact with particular emphasis on any change
approvals, analytical validation, pilot or full-scale process batch, stability set down .
Typical technology transfer process was described in:-
For a typical research-based pharmaceutical company, drug discovery and
development can be broken down into distinct stages which were clearly
described :-
Typical process development work flow in pharmaceutical industry.
STEPS INVOLVED IN TECHNOLOGY
TRANSFER:
Transformation of Pharmaceutical prototype into a successful
product needs the cooperation of many people. During
development of a formulation, it is vital to understand procedure
of operations used, critical and non-critical parameters of every
operation, production environment, instrumentation, and
excipient convenience, that ought to be taken into consideration
throughout the first phases of development of formulation, so
that successful scale-up can be carried out.
VARIOUS STEPS CONCERNED IN TECHNOLOGY TRANSFER
AS FOLLOWS: -
1] Research Phase (Development of Technology by R&D)
2] Technology Transfer from R & D to Production (Development Phase)
3] Optimization and Production (Production Phase)
Research Phase (Development of Technology by R&D):
a) Design and Choice of Excipients by R&D:
choice of materials and design of procedures are carried out by R&D on the premise of innovator product
characteristics. For this completely different tests and compatibility, studies are performed.
b) Identification of Specifications and Quality by R&D:
Quality of product ought to meet the specifications of an innovator product. For this stability, studies are carried
out for innovator product and for product that is to be manufactured.
Technology Transfer from R & D to Production
(Development Phase):
R&D provides technology transfer dossier (TTD) document to a product development laboratory that
contains all data of formulation and drug product as given below:
a) Master Formula Card (MFC):
It includes product name along with its strength,
b) The generic name, MFC number, page number, effective date, shelf life,
and market.
c) Master Packaging Card: It provides data regarding packaging sort, the material used for
packaging, stability profile of packaging and shelf life of packaging.
d) Master Formula: It describes formulation order and manufacturing instructions. Formulation
order and Manufacturing Instructions offer the plan of process order, surroundings conditions needed
and manufacturing instructions for the development of dosage form.
e) Specifications and Standard Test Procedures (STPs): These help to know
active ingredients and excipients profile, inprocess parameters and specifications, product release
specifications and finished product details.
Optimization and Production (Production Phase):
a) Validation Studies:
Validation studies verify that the method will stabilize the product based on transferred manufacturing
formula and production is enforced once validation studies. The manufacturing department is accepting
technology and liable for validation. The research and development department transferring technology
ought to take responsibility for validation like performance qualification, cleaning and method
validation.
b) Scale Up for Production:
Scale up involves the transfer of technology throughout small scale development of the product and
processes. It’s essential to contemplate the production surroundings and system throughout the
development of the method. Operators ought to target keeping in mind that the production process can
run smoothly if technology transfer is enforced thoughtfully. Effective technology transfer helps to
provide process efficiency and maintain product quality.
TECHNOLOGY TRANSFER TEAM:-
TECHNOLOGY TRANSFER
DOCUMENTATION:
Technology transfer document demonstrates the contents of technology transfer from
transferring and transferred parties. Each step from research and development to
production should be documented, task assignments and responsibilities ought to be
processed and acceptance criteria for completion of technology transfer regarding
individual technology to be transferred. Its duty of the Quality Assurance department to
examine and approve the documentation for all processes of technology transfer .
a) Development Report:
It is used at the preapproval examination as a valid document for quality design of new
drug. The ultimate goal for successful technology transfer is to possess documented
evidence. The R&D report may be a file of technical development, and also the research
and development department is accountable for its documentation. This report is a
crucial file to point rationale for the quality design of drug substances and drug
specifications and test methods. Additionally, this report can be used as raw data just in
case of post-marketing technology transfer.
b) Technology Transfer Plan:
The technology transfer plan describes the things and contents of technology to be transferred
and elaborate procedures of individual transfer and transfer schedule, and to determine
judgment criteria for the completion of the transfer. The transferring party ought to prepare the
plan before the implementation of the transfer and reach an agreement on its contents with the
transferred party.
c) Report:
Report completion of technology transfer is to be created once information is taken
consequently to the plan and are evaluated to substantiate that the planned judgment criteria are
met. Both transferring and transferred parties will document the technology transfer report; but,
they must reach an agreement on its contents.
d) Exhibit:
After taking a scale-up batch of the product, manufacturing of exhibit batches take place. In
case of exhibit, batch sizes are increased along with equipment, and their process is involved.
They are done for filing purposes in different regulatory agencies.
IMPLEMENTATION OF TECHNOLOGY TRANSFER:
Avoids the technology transfer only by handing over the technology transfer documentation .
Both parties should cooperate in implementing technology education training and validation at
facilities where the transferred technology is actually used.
VERIFICATION OF RESULT OF TECHNOLOGY
TRANSFER:
After the completion of technology transfer and before the start of manufacturing of the product, the
transferring party should verify with appropriate methods such as product testing and audit that the
product manufactured after the technology transfer meets the predetermined quality and should
maintain records of the results
CONCLUSION
In pharmaceutical trade, technology transfer suggests that action to transfer of
data and technologies necessary to realize quality of design of drugs throughout
manufacturing. The technology transfer does not mean one-time actions taken by
the transferring party toward the transferred party however, suggest that
continuous information exchange between both the parties to maintain the
product manufacturing. Technology transfer is a complex issue and should be
deal with using holistic approach.
REFERENCES:
1. Sajid A, Vinay P and Chander S: Technology transfer in Pharmaceuticals. IRJP 2012;
3(6): 43-48.
2. Gupta, Surbhi S and Seema: Technology transfer in the pharmaceutical industry - an overview.
International Pharmaceutica Sciencia 2012; 2(3): 1-6.
3. Mohite PB and Sangle SV: Technology transfer in the pharmaceutical industry- a review.
International Journal of Advances in Pharmaceutics 2017; 06(01): 01-07.
4. Patil RP: Technology Transfer in Pharmaceutical Industry: objectives, Issues and Policy Approaches.
Int J Pharm Res Dev 2010; 2(10): 43-48.
5. Waghmare YS and Mahaparale SP: The important role of technology transfer in the pharmaceutical
industry-a review. World Journal of Pharmaceutical Research 2017; 6(9): 310-29.
6. Manral MS, Prashar B and Sheikh Y: Technology transfer in the pharmaceutical industry; facts
and steps involved. Am J Pharm Tech Res 2012; 2(4): 74-82.
7. Amanjeet S and Geeta A: Technology transfer in the pharmaceutical industry: a discussion.
International Journal of Pharma and Bio Sciences 2010; 1(3):1-3.
8. Ahad M. Osman‐Gani, A. International technology transfer for competitive advantage: a conceptual
analysis of the role of HRD. Competitiveness Review 1999; 9(1): 9-1.
9. Sagar P, Akshay K, Pankaj P, Mayur G and Shivram J: Review article on technology transfer.
International Journal of pure and applied Bioscience 2014; 2(3): 145-53.
10. Patil PR: Technology transfer in pharmaceutical industry: objectives, issues and policy approach.
International Journal of Pharma Research and Development 2010; 3: 43- 8
11. https://www.who.int/docs/default-source/medicines/norms and
standards/guidelines/production/trs961-annex7-transfer-technology pharmaceutical
manufacturing. pdf? Sfvrsn =2e302838_0
12.https://www.who.int/medicines/areas/quality_safety/quality
assurance/TRS986annex2.pdf?u a=1
13. https://www.who.int/medicines/areas/quality_safety/quality assurance/WHO TRS 1019
Annex3.pdf?ua=1
14.http://digicollection.org/whoqapharm/documents/s20093en/s20093en.pdf
15.https://www.who.int/medicines/areas/quality_safety/qualityassurance/Local
manufacturing risk-QAS16-682 24082016.pdf?ua=1
THANK YOU

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CURRENT ASPECTS OF TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY

  • 1. CURRENT ASPECTS OF TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY PREPARED BY- SAYAN MAHAPATRA M.PHARM ( QUALITY ASSURANCE) ROLL NO-07 UNDER THE GUIDANCE OF Dr. JEYA PRAKASH M. R
  • 2. CONTENTS ■ INTRODUCTION ■ THE IMPORTANCES OF TECHNOLOGY TRANSFER ■ REASON FOR TECHNOLOGY TRANSFER ■ FACTOR AFFECTING THE SUCCESS OF TECHNOLOGY TRANSFER ■ LIFE CYCLE APPROACH ■ TECHNOLOGY TRANSFER PROCESS ■ STEPS INVOLVED IN TECHNOLOGY TRANSFER ■ TECHNOLOGY TRANSFER TEAM ■ TECHNOLOGY TRANSFER DOCUMENTATION ■ IMPLEMENTATION OF TECHNOLOGY TRANSFER ■ VERIFICATION OF RESULT OF TECHNOLOGY TRANSFER ■ CONCLUSION ■ REFERENCES
  • 3.
  • 4. INTRODUCTION 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.
  • 5. THE IMPORTANCE OF TECHNOLOGY TRANSFER ARE:- • * To elucidate necessary information to transfer technology from R&D to actual manufacturing by sorting out various information obtained during R&D. • * To elucidate necessary information to transfer technology of existing products between various manufacturing places. • * To exemplify specific procedures and points of concern for the two types of technology transfer in the above to contribute to smooth technology transfer. This is applicable to the technology transfer through R&D and production of drug and the technology transfer related to post-marketing changes in manufacturing places. • Various stages of formulation development were as follows 1. Preformulation studies. 2. Bench scale - (1/1000th of X) 3. Lab scale - (1/100th of X) 4. Scale up- (1/10th of X or 0.1M whichever is maximum) 5. Commercial (X) Where X is the final commercial scale batch size.
  • 6. REASON FOR TECHNOLOGY TRANSFER :- Lack of Manufacturing Capacity: the developer of the technology could solely have to produce instrumentation that appropriates for lab and small scale operations and should partner with another organization to try to do massive scale manufacturing. Lack of Resources to Launch Product Commercially: The original inventor of technology may only have resources to conduct early stages research and phase - I and II clinical trials. Lack of Marketing Distribution and Distribution Capability: The developer of the technology could have absolutely developed technology and even have obtained regulative approvals and product registration, but it may not have the marketing and distribution channels and should collaborate within another organization that has the capability.
  • 7. FACTORS AFFECTING THE SUCCESS OF TECHNOLOGY TRANSFER:- • Unlike the greenfield R & D project, the technology transfer is the importation of a developed R & D product from outside the company. Therefore, a complete background of technology with it's possible strengths & weaknesses need to be understood in the beginning. • Issues related to costs, royalty, royalty payment, milestone payments need to be considered before the technology transfer is to be opted. If this due diligence is not done correctly, the project may loose it's priority within the company. • Regulatory issues including 'difficult to resolve' issues need to be correctly addressed while the project is on. • Accurate calculations of time-lines with enough margins for development/ scale-up related issues, country of licencing, regulatory guidelines existing in the country of origin, need to be taken into account • Lastly, the major factor is a team which accepts the technology & the team that offers the technology should have complete understanding of the entire project & needs to develop a personal report besides official project structure.
  • 8. LIFE CYCLE APPROACH:- 1. The relevant stage of the life cycle of the facility, equipment, instrument, utility, product, process or procedure to be transferred should be taken into consideration when the transfer is planned and executed. This also applies to the control strategy and process validation. 2. The responsible entities should monitor the progress of the project at each applicable stage of the life cycle aspect of the transfer to ensure a successful completion of the transfer.
  • 9. TECHNOLOGY TRANSFER PROCESS:- Technology transfer is both integral and critical to the drug discovery and development process for new medicinal products. The decision to transfer products between manufacturing sites is frequently driven by economics. Key stages of the process include data collection, data review, regulatory impact with particular emphasis on any change approvals, analytical validation, pilot or full-scale process batch, stability set down . Typical technology transfer process was described in:-
  • 10.
  • 11. For a typical research-based pharmaceutical company, drug discovery and development can be broken down into distinct stages which were clearly described :- Typical process development work flow in pharmaceutical industry.
  • 12. STEPS INVOLVED IN TECHNOLOGY TRANSFER: Transformation of Pharmaceutical prototype into a successful product needs the cooperation of many people. During development of a formulation, it is vital to understand procedure of operations used, critical and non-critical parameters of every operation, production environment, instrumentation, and excipient convenience, that ought to be taken into consideration throughout the first phases of development of formulation, so that successful scale-up can be carried out.
  • 13. VARIOUS STEPS CONCERNED IN TECHNOLOGY TRANSFER AS FOLLOWS: - 1] Research Phase (Development of Technology by R&D) 2] Technology Transfer from R & D to Production (Development Phase) 3] Optimization and Production (Production Phase)
  • 14. Research Phase (Development of Technology by R&D): a) Design and Choice of Excipients by R&D: choice of materials and design of procedures are carried out by R&D on the premise of innovator product characteristics. For this completely different tests and compatibility, studies are performed. b) Identification of Specifications and Quality by R&D: Quality of product ought to meet the specifications of an innovator product. For this stability, studies are carried out for innovator product and for product that is to be manufactured.
  • 15. Technology Transfer from R & D to Production (Development Phase): R&D provides technology transfer dossier (TTD) document to a product development laboratory that contains all data of formulation and drug product as given below: a) Master Formula Card (MFC): It includes product name along with its strength, b) The generic name, MFC number, page number, effective date, shelf life, and market. c) Master Packaging Card: It provides data regarding packaging sort, the material used for packaging, stability profile of packaging and shelf life of packaging. d) Master Formula: It describes formulation order and manufacturing instructions. Formulation order and Manufacturing Instructions offer the plan of process order, surroundings conditions needed and manufacturing instructions for the development of dosage form. e) Specifications and Standard Test Procedures (STPs): These help to know active ingredients and excipients profile, inprocess parameters and specifications, product release specifications and finished product details.
  • 16. Optimization and Production (Production Phase): a) Validation Studies: Validation studies verify that the method will stabilize the product based on transferred manufacturing formula and production is enforced once validation studies. The manufacturing department is accepting technology and liable for validation. The research and development department transferring technology ought to take responsibility for validation like performance qualification, cleaning and method validation. b) Scale Up for Production: Scale up involves the transfer of technology throughout small scale development of the product and processes. It’s essential to contemplate the production surroundings and system throughout the development of the method. Operators ought to target keeping in mind that the production process can run smoothly if technology transfer is enforced thoughtfully. Effective technology transfer helps to provide process efficiency and maintain product quality.
  • 17.
  • 19.
  • 20.
  • 21.
  • 22. TECHNOLOGY TRANSFER DOCUMENTATION: Technology transfer document demonstrates the contents of technology transfer from transferring and transferred parties. Each step from research and development to production should be documented, task assignments and responsibilities ought to be processed and acceptance criteria for completion of technology transfer regarding individual technology to be transferred. Its duty of the Quality Assurance department to examine and approve the documentation for all processes of technology transfer . a) Development Report: It is used at the preapproval examination as a valid document for quality design of new drug. The ultimate goal for successful technology transfer is to possess documented evidence. The R&D report may be a file of technical development, and also the research and development department is accountable for its documentation. This report is a crucial file to point rationale for the quality design of drug substances and drug specifications and test methods. Additionally, this report can be used as raw data just in case of post-marketing technology transfer.
  • 23. b) Technology Transfer Plan: The technology transfer plan describes the things and contents of technology to be transferred and elaborate procedures of individual transfer and transfer schedule, and to determine judgment criteria for the completion of the transfer. The transferring party ought to prepare the plan before the implementation of the transfer and reach an agreement on its contents with the transferred party. c) Report: Report completion of technology transfer is to be created once information is taken consequently to the plan and are evaluated to substantiate that the planned judgment criteria are met. Both transferring and transferred parties will document the technology transfer report; but, they must reach an agreement on its contents. d) Exhibit: After taking a scale-up batch of the product, manufacturing of exhibit batches take place. In case of exhibit, batch sizes are increased along with equipment, and their process is involved. They are done for filing purposes in different regulatory agencies.
  • 24. IMPLEMENTATION OF TECHNOLOGY TRANSFER: Avoids the technology transfer only by handing over the technology transfer documentation . Both parties should cooperate in implementing technology education training and validation at facilities where the transferred technology is actually used. VERIFICATION OF RESULT OF TECHNOLOGY TRANSFER: After the completion of technology transfer and before the start of manufacturing of the product, the transferring party should verify with appropriate methods such as product testing and audit that the product manufactured after the technology transfer meets the predetermined quality and should maintain records of the results
  • 25. CONCLUSION In pharmaceutical trade, technology transfer suggests that action to transfer of data and technologies necessary to realize quality of design of drugs throughout manufacturing. The technology transfer does not mean one-time actions taken by the transferring party toward the transferred party however, suggest that continuous information exchange between both the parties to maintain the product manufacturing. Technology transfer is a complex issue and should be deal with using holistic approach.
  • 26. REFERENCES: 1. Sajid A, Vinay P and Chander S: Technology transfer in Pharmaceuticals. IRJP 2012; 3(6): 43-48. 2. Gupta, Surbhi S and Seema: Technology transfer in the pharmaceutical industry - an overview. International Pharmaceutica Sciencia 2012; 2(3): 1-6. 3. Mohite PB and Sangle SV: Technology transfer in the pharmaceutical industry- a review. International Journal of Advances in Pharmaceutics 2017; 06(01): 01-07. 4. Patil RP: Technology Transfer in Pharmaceutical Industry: objectives, Issues and Policy Approaches. Int J Pharm Res Dev 2010; 2(10): 43-48. 5. Waghmare YS and Mahaparale SP: The important role of technology transfer in the pharmaceutical industry-a review. World Journal of Pharmaceutical Research 2017; 6(9): 310-29. 6. Manral MS, Prashar B and Sheikh Y: Technology transfer in the pharmaceutical industry; facts and steps involved. Am J Pharm Tech Res 2012; 2(4): 74-82. 7. Amanjeet S and Geeta A: Technology transfer in the pharmaceutical industry: a discussion. International Journal of Pharma and Bio Sciences 2010; 1(3):1-3. 8. Ahad M. Osman‐Gani, A. International technology transfer for competitive advantage: a conceptual analysis of the role of HRD. Competitiveness Review 1999; 9(1): 9-1. 9. Sagar P, Akshay K, Pankaj P, Mayur G and Shivram J: Review article on technology transfer. International Journal of pure and applied Bioscience 2014; 2(3): 145-53. 10. Patil PR: Technology transfer in pharmaceutical industry: objectives, issues and policy approach. International Journal of Pharma Research and Development 2010; 3: 43- 8
  • 27. 11. https://www.who.int/docs/default-source/medicines/norms and standards/guidelines/production/trs961-annex7-transfer-technology pharmaceutical manufacturing. pdf? Sfvrsn =2e302838_0 12.https://www.who.int/medicines/areas/quality_safety/quality assurance/TRS986annex2.pdf?u a=1 13. https://www.who.int/medicines/areas/quality_safety/quality assurance/WHO TRS 1019 Annex3.pdf?ua=1 14.http://digicollection.org/whoqapharm/documents/s20093en/s20093en.pdf 15.https://www.who.int/medicines/areas/quality_safety/qualityassurance/Local manufacturing risk-QAS16-682 24082016.pdf?ua=1