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• PRESENTD BY :-
• AMIT
• FIRSTYEAR M.PHARM.
• DEPARTMENT OF QUALITYASSURANCE.
Institute of Pharmaceutical Science
Kurukshetra university kurukshetra
1
Introduction1-4
2
 Technology transfer is the practice of transferring scientific findings from
one organization to another for further development.
 Which is mainly concerned with the transfer of technology from the
research areas to the “Production and Quality Assurance” environment.
 The process by which existing knowledge , facilities or capabilities
developed under R & D are utilized to fulfill public and private need.
 It is the process bywhich a developerof technology makes its
technology available to commercial partner that will exploit
technology.
 Technologytransfer is the intersection between business, science,
engineering, lawand government.
3
Reasons for Technology Transfer4
4
 Lack of manufacturing capacity.
 Lack of resources to launch productcommercially.
 Lack of marketing and distributioncapability.
 Form technologyalliance toexploit each other’sstrength.
Technology Transfer Agents
R&D Units
• Universities.
• Public Research Centers.
• Technology Institutes
(institutions, labsetc).
Companies
• Supplierof technology
and R&D to third parties.
• Large R&D department
5
• Suppliers…
IDEA
Research
Development
Production
Manufacturing
Distribution
Start-up
Firms
R & D
Firms
Larger
Companies
Universities
Research
Institutes
MARKET
6
TYPES OF TECHNOLOGY5
7
that currently is
1)EMERGING TECHNOLOGY- It is a technology
undergoing batch scale testing.
2)INNOVATIVE TECHNOLOGY- It is a technology that the underthe scale
up.
It is a technology which already
3)ESTABLISHED TECHNOLOGY-
established in market.
CONTENT OF TECHNOLOGY TRANSFER5-6
Proper
Research
Proper
work
Pricing
Publicity
Partnership
People’s
Acceptance
6 P
8
 Proper Research – By proper researchwe mean firstly that in which
the resultare reproducibleand issuessuch as scale up.
 Properwork - This refer towork should be in properway, so that
properguidancewill available forfurtherdevelopment.
9
 Pricing –
-Too high pricecan putoff buyer, leaving the technology unsold.
- Thereare basically two model regarding pricing
1) Pricecharged fora technologyshould depend upon market force.
2) Pricecharged should includeall expenses involved in developing it.
 Publicity – It is important to identify and then approach buyer i.e.
adopt targeted Publicityand not blanket publicity.
10
 Partnership – This means working along with industry. Industry takes
it up, manufacturer and makes available to society. Partnership are
importanttoensureyourtechnology is successfullyadopted.
 People’s Acceptance – It is no use trying todevelopa technology
which people will notaccept.
11
Steps involved in Technology Transfer3
12
1. Developmentof technology by R & D:
a. Design of procedureand selectionof excipients by R & D
b. Identificationof specification and quality by R & D
2. Technologytransferfrom R & D toproduction:
a. Masterformulacard.
b. Masterpackaging card.
c. Masterformula.
d. Specifications & standard testprocedure.
3. Optimizationand Production:
a. Validationstudies
b. Scale up forproduction
4. Technologytransferdocumentation:
a. Developmentreport.
b. Technology transferplan.
c. Report.
5. Check & Approval:
13
FUNCTION OF TECHNOLOGY TRANSFER TEAM5
14
 Coordinate- Coordinating between technology users and developers,
between researchers and manufactures is an important element of
technology transfer.
 Nature- A main ingredient for moving technology from a research
laboratory to a new business enterprise successfully is an environment
that is supportive.
 Link- Cataloging resources related to business enterprises and
connecting would be researchers and other technology developers to
outside groups and organizations which can help in the process of
starting new products, companies etc.
FACTOR AFFECTING TECHNOLOGY TRANSFER5
15
 Communication Factor
 Financial Factor
 External Factor
 Human Factor
 Corporate Factor
 Technologyfactor
Technology Transfer Checklist2,6
16
1) Production masterformula.
2) Manufacturing instruction.
3) Dispensing instruction.
4) Analytical methods.
5) Previous processvalidation.
6) Stabilityreport.
7) Excipients specification & source.
8) Activespecification & source.
9) Primary packaging material specification & source.
10) Packaging instruction.
11) Customercomplaints.
12) Processdeviation file.
13) Analytical deviation file.
14) Reject/Rework file.
15) Specimen manufacturing batch record.
16) Specimen cartons , Labels.
17
Objectives of Technology Transfer
18
 Toofferguidance & assistance to inventors & corporation.
 To providea hands-on learning opportunity.
 To increase thegeneral awareness.
 Toacceleratescale-up and cost reduction.
EXAMPLE OF TECHNOLOGY TRANSFER7
19
 Chinesecompanyoffertechnology forthe productionof L-
Phenyl alanine by theenzyme method.
Areaof Application
# Food industry
Advantage-
 Advanced process.
 Noenvironmental contamination.
 Clearproduction.
Stageof development
 Commercialized
Economicdata
 Total projectcost 4 million
 Equipment1.38million
Targetcountry
 world wide
Language
 English
20
INSTITUTE IN INDIA ASSISTING IN TECHNOLOGY
TRANSFER8
21
 Asia Pacific Centre forTransferof Technology (APCTT)
-APCTT is a regional institution of the United Nations Economic and
Social Commission forAsiaand the Pacific, servicing the Asia-Pacific
region.
-It was established in 1977 with the objective of facilitating technology
transfer in the Asia-Pacific region. The Centre headquartered in New
Delhi with host facilities provided by the Governmentof India.
 Technology Bureau for Small Enterprises (TBSE).
22
 National Research & Development Corporation.
 Foundation for Innovationand TechnologyTransfer.
Conclusion
23
 In pharmaceutical industry, technology transfer means action to
transferof informationand technologies necessary torealizequalityof
designof drugsduring manufacturing.
 In pharmaceutical industry technology transferrefers toThe journey
fromdrug discoveryto full scalecommercialization.
 Effective technology transfer helps toprovide process efficiency ,
control and maintain productquality
References
24
1. Savant DA. The Pharmaceutical Sciences – Pharma Pathaway. Nirali Prakashan. 8th ed.
Chapter 46, Technology Transfer Guidence; 2010, July: 2.325-2.349.
2. Berry IR. Technology Transfer Consideration for Pharmaceuticals. Encyclopaedia of
Pharmaceutical Technology. Wiley India Pvt. Ltd, New Delhi; 3rd ed. 2006: 20-30.
3. SinghA,Aggarwal G. Technology Transfer in Pharmaceutical Industry:ADiscussion. Int.J.
of Pharma and Bio Sci; 2010,Jul- Sub. 1(3):1-5.
4. Feifei Y,Yingming Y. Research on Technology Transfer in the Pharmaceutical Industry.
Ind.j. of Pharm. Sci. IPA; 2008, July-Aug; 70(4):11-14.
5. http://www.gdrc.org/uem/techtran.html
6. http://bud.tic.ab.ca/venquest/yqt_home.html
7. http://www.informaworld.com/smpp/title~conte
nt=t713172974
8. http://www.apctt.org/about_us/aboutus.html
25
26

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Technology Transfer in Pharmaceutical Industry

  • 1. • PRESENTD BY :- • AMIT • FIRSTYEAR M.PHARM. • DEPARTMENT OF QUALITYASSURANCE. Institute of Pharmaceutical Science Kurukshetra university kurukshetra 1
  • 2. Introduction1-4 2  Technology transfer is the practice of transferring scientific findings from one organization to another for further development.  Which is mainly concerned with the transfer of technology from the research areas to the “Production and Quality Assurance” environment.  The process by which existing knowledge , facilities or capabilities developed under R & D are utilized to fulfill public and private need.
  • 3.  It is the process bywhich a developerof technology makes its technology available to commercial partner that will exploit technology.  Technologytransfer is the intersection between business, science, engineering, lawand government. 3
  • 4. Reasons for Technology Transfer4 4  Lack of manufacturing capacity.  Lack of resources to launch productcommercially.  Lack of marketing and distributioncapability.  Form technologyalliance toexploit each other’sstrength.
  • 5. Technology Transfer Agents R&D Units • Universities. • Public Research Centers. • Technology Institutes (institutions, labsetc). Companies • Supplierof technology and R&D to third parties. • Large R&D department 5 • Suppliers…
  • 7. TYPES OF TECHNOLOGY5 7 that currently is 1)EMERGING TECHNOLOGY- It is a technology undergoing batch scale testing. 2)INNOVATIVE TECHNOLOGY- It is a technology that the underthe scale up. It is a technology which already 3)ESTABLISHED TECHNOLOGY- established in market.
  • 8. CONTENT OF TECHNOLOGY TRANSFER5-6 Proper Research Proper work Pricing Publicity Partnership People’s Acceptance 6 P 8
  • 9.  Proper Research – By proper researchwe mean firstly that in which the resultare reproducibleand issuessuch as scale up.  Properwork - This refer towork should be in properway, so that properguidancewill available forfurtherdevelopment. 9
  • 10.  Pricing – -Too high pricecan putoff buyer, leaving the technology unsold. - Thereare basically two model regarding pricing 1) Pricecharged fora technologyshould depend upon market force. 2) Pricecharged should includeall expenses involved in developing it.  Publicity – It is important to identify and then approach buyer i.e. adopt targeted Publicityand not blanket publicity. 10
  • 11.  Partnership – This means working along with industry. Industry takes it up, manufacturer and makes available to society. Partnership are importanttoensureyourtechnology is successfullyadopted.  People’s Acceptance – It is no use trying todevelopa technology which people will notaccept. 11
  • 12. Steps involved in Technology Transfer3 12 1. Developmentof technology by R & D: a. Design of procedureand selectionof excipients by R & D b. Identificationof specification and quality by R & D 2. Technologytransferfrom R & D toproduction: a. Masterformulacard. b. Masterpackaging card. c. Masterformula. d. Specifications & standard testprocedure.
  • 13. 3. Optimizationand Production: a. Validationstudies b. Scale up forproduction 4. Technologytransferdocumentation: a. Developmentreport. b. Technology transferplan. c. Report. 5. Check & Approval: 13
  • 14. FUNCTION OF TECHNOLOGY TRANSFER TEAM5 14  Coordinate- Coordinating between technology users and developers, between researchers and manufactures is an important element of technology transfer.  Nature- A main ingredient for moving technology from a research laboratory to a new business enterprise successfully is an environment that is supportive.  Link- Cataloging resources related to business enterprises and connecting would be researchers and other technology developers to outside groups and organizations which can help in the process of starting new products, companies etc.
  • 15. FACTOR AFFECTING TECHNOLOGY TRANSFER5 15  Communication Factor  Financial Factor  External Factor  Human Factor  Corporate Factor  Technologyfactor
  • 16. Technology Transfer Checklist2,6 16 1) Production masterformula. 2) Manufacturing instruction. 3) Dispensing instruction. 4) Analytical methods. 5) Previous processvalidation. 6) Stabilityreport. 7) Excipients specification & source. 8) Activespecification & source.
  • 17. 9) Primary packaging material specification & source. 10) Packaging instruction. 11) Customercomplaints. 12) Processdeviation file. 13) Analytical deviation file. 14) Reject/Rework file. 15) Specimen manufacturing batch record. 16) Specimen cartons , Labels. 17
  • 18. Objectives of Technology Transfer 18  Toofferguidance & assistance to inventors & corporation.  To providea hands-on learning opportunity.  To increase thegeneral awareness.  Toacceleratescale-up and cost reduction.
  • 19. EXAMPLE OF TECHNOLOGY TRANSFER7 19  Chinesecompanyoffertechnology forthe productionof L- Phenyl alanine by theenzyme method. Areaof Application # Food industry Advantage-  Advanced process.  Noenvironmental contamination.  Clearproduction.
  • 20. Stageof development  Commercialized Economicdata  Total projectcost 4 million  Equipment1.38million Targetcountry  world wide Language  English 20
  • 21. INSTITUTE IN INDIA ASSISTING IN TECHNOLOGY TRANSFER8 21  Asia Pacific Centre forTransferof Technology (APCTT) -APCTT is a regional institution of the United Nations Economic and Social Commission forAsiaand the Pacific, servicing the Asia-Pacific region. -It was established in 1977 with the objective of facilitating technology transfer in the Asia-Pacific region. The Centre headquartered in New Delhi with host facilities provided by the Governmentof India.
  • 22.  Technology Bureau for Small Enterprises (TBSE). 22  National Research & Development Corporation.  Foundation for Innovationand TechnologyTransfer.
  • 23. Conclusion 23  In pharmaceutical industry, technology transfer means action to transferof informationand technologies necessary torealizequalityof designof drugsduring manufacturing.  In pharmaceutical industry technology transferrefers toThe journey fromdrug discoveryto full scalecommercialization.  Effective technology transfer helps toprovide process efficiency , control and maintain productquality
  • 24. References 24 1. Savant DA. The Pharmaceutical Sciences – Pharma Pathaway. Nirali Prakashan. 8th ed. Chapter 46, Technology Transfer Guidence; 2010, July: 2.325-2.349. 2. Berry IR. Technology Transfer Consideration for Pharmaceuticals. Encyclopaedia of Pharmaceutical Technology. Wiley India Pvt. Ltd, New Delhi; 3rd ed. 2006: 20-30. 3. SinghA,Aggarwal G. Technology Transfer in Pharmaceutical Industry:ADiscussion. Int.J. of Pharma and Bio Sci; 2010,Jul- Sub. 1(3):1-5. 4. Feifei Y,Yingming Y. Research on Technology Transfer in the Pharmaceutical Industry. Ind.j. of Pharm. Sci. IPA; 2008, July-Aug; 70(4):11-14.
  • 25. 5. http://www.gdrc.org/uem/techtran.html 6. http://bud.tic.ab.ca/venquest/yqt_home.html 7. http://www.informaworld.com/smpp/title~conte nt=t713172974 8. http://www.apctt.org/about_us/aboutus.html 25
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