Technology transfer

1. TRANSFER OF TECHNOLOGY
PRESENTED BY:
VINITH KUMAR V
M PHARM FIRST SEM
DEPARTMENT OF PHARMACEUTICAL ANALYSIS.
1

2. CONTENTS:
INTRODUCTION
METHODS OF TRANFER TECHNOLOGY
TRANSFER TECHNOLOGY IN PHARMACEUTICAL INDUSTRY
STEPS INVOLVED IN TRANSFER TECHNOLOGY
POSITIVE AND NEGATIVE ASPECTS OF IPP
CONCULSION
2

3. INTRODUCTION
Technology transfer, also called transfer of technology (TOT). Technology
transfer is the process by which a developer of technology makes its
technology available to a commercial partner that will exploit the
technology.
In pharmaceutical industry, “Technology transfer” refers to the processes
of successful progress from drug discovery to product development,
clinical trials and ultimately full-scale commercialization.
3

4. 4

5. IMPORTANCE OF TRANSFER TECHNOLOGY
• It is used as a direct tool by the research community or a new
platforms, products or services to be made into products for public
use.
• A successful collaboration is formed between researchers across
different universities in order to advance the knowledge in a particular
field or further develop a technology.
5

6. REASONS FOR TRANFER TECHNOLOGY
• Due to lack of manufacturing capacity
• Due to lack of resources to launch product commercially
• Due to lack of marketing distribution and distribution capability
List of institutes assisting in technology transfer:
Asia Pacific Center for Transfer of Technology (APCTT)
Technology Bureau for small enterprise (TBSE)
National research and development co-operation.
6

7. METHODS FOR TRANSFER TECHNOLOGY
LICENSING
Licensing is an agreement under which the owner of a patent, trademark or
other intellectual property gives the permission to another company to use the
technology developed by him or her, in a certain area during a certain period of
time.
There are mainly two types of licenses-
• An exclusive right to use the technology.
• Non-exclusive right, which implies that the patent owner may
transfer the right to use the technology to other companies in the same area.
7

8. JOINT VENTURE
A joint venture is an agreement concluded between two or more
companies in order to execute a particular business. The joint venture implies
mutual assets, management, profit sharing, co-production, services and
marketing.
FOREIGN COMPANY ACQUISITION
A company may acquire a foreign start-up which is developing a new
technology. As a result, the company will not only get the technology, but also
a team capable to develop it in the future.
8

9. ASPECTS OF TRANSFER TECHNOLOGY
 Govt. laboratories to private sector.
 Between private sectors of same country.
 From academics to private sectors.
 Between academy, private and govt. sectors .
Govt. labs to private sectors: Its advantageous as the Govt. labs can get
good financial support and funds from the govt. for their research work and
the technology developed by them reaches the private sector.
9

10. Between private sectors of same country: It occurs due to lack of
appropriate financial resources or inadequate knowledge of regulatory
requirements, thus the private sector that develops the technology is paid
by other sector that absorbs the technology.
From academics to private sectors: Academic sectors that are actively
involved in research and development the technology and make it
available to private firms.
 Between academy, private and govt. sectors: In this type ,govt .
provides necessary funds to the academic institutions in developing
technology that can be transferred to the industry.
10

11. TECHNOLOGY TRANSFER IN PHARMACEUTICAL
INDUSTRY
Technology transfer is an integral part of New Drug Discovery and
development of new medicinal products.
The Departments responsible in a pharmaceutical industry are-
R & D process technologist
Quality assurance Representative
Production Representative
Engineering Representative
Quality control Representative
11

12. ROLES RESPONSIBILITES
Process Technologist  Central focus for transfer activities .
 Collates documents and internal assessment taken by him for feasibility,
compatibility, etc.
QA
Representative
 Reviews documentation to determine compliance with marketing
authorization (MA).
 Reviews analytical methods with QC to determine capability, equipment
training requirements.
Production representative  Reviews process instructions (with process technologist) to confirm capacity
and capability .
 Consider any safety implications, e g, solvents; toxic; sanitizing materials.
12

13. ROLES RESPONSIBILITES
Engineering Representative  Reviews (with production representative) equipment requirement.
 Initiates required engineering modifications, change or part purchase
 Reviews preventative maintenance and calibration impact.
QC
Representative
 Reviews analytical requirement.
 Availability with instruments.
 Responsible for analytical method transfer for drug substance and
drug product.
13

14. STEPS INVOLVED IN TRANSFER TECHNOLOGY
REAEARCH PHASE
DEVELOPMENT PHASE
PRODUCTION PHASE
14

15. RESEARCH PHASE:
This process includes the design of procedure and selection of materials by
research and development on the basis of innovator product characteristics.
Quality Design:
For drug products the quality design corresponds to pharmaceuticals design
to design properties and functions such as
• Elimination of adverse reactions.
• Improvement of efficacy.
• Assurance of stability during distribution.
15

16. DEVELOPMENT PHASE:
Master Formula Card (MFC)- Includes product name along with its strength, generic
name, MFC number, page number, effective date, shelf life and market
Master Packing Card- Gives information about packaging type, material used for
packaging, stability profile and shelf life of packaging.
Master Formula- Describes formulation order and manufacturing instructions.
(Process order and environment conditions)
Specifications and Standard Test Procedures (STP'S)- Helps to know active
ingredients and excipients profile, in-process parameters, product release
specifications and finished product details.
16

17. PRODUCTION PHASE:
a. Validation and Production :
Production is implemented after various validation studies verify that it is able to
stable product based on transferred manufacturing formula.
b. Scale up for production: Scale up involves the transfer of technology during
small scale development of the product and processes . Effective technology
transfer helps to provide process efficiency and maintain product quality.
c. Considerations of different parameters for scale-up: are flexibility, cost,
dependability, innovation and product quality. It was important to realize that
good communication was critical for formulation and process transfer to be
successful.
17

18. GIVING SITE RECEIVING SITE
 Provide Latest Source documentation.  Execute Protocol(analytical method)
 Latest Specifications (Internal or
registered).
 Qualified Facility and equipment or
instrument.
 Provide process(technology) transfer.  Setup system.
 Protocol/report (analytical report method).  Setup training program.
18

19. 19
CHECK LIST FOR TECHNOLOGY TRANSFER
• Production master formula.
• Manufacturing and Dispensing instructions.
• Analytical methods.
• Cleaning instructions and previous cleaning validation.
• Active specifications and source.
• Primary packaging material specifications and source.
• Packaging instructions.
• Process deviations file, Analytical deviations file.

20. EXAMPLE FOR TECHNOLOGY TRANSFER
• Amphotericin B (Polyene Macrolide Antibiotic)
• In existence for over 3 decades as one of the most potent anti-fungal agents .
• Had limited applications mainly due to severe nephrotoxicity, cardiotoxicity to
central nervous system.
FUNGISOME, India's first Liposomal Amphotericin B
• Uses liposome as a carrier for Amphotericin B
• Highly effective and less toxic as it can carry drug at the specific site and is
required in much lower concentration
20

21. TECHNOLOGY DEVELOPMENT
• Prof. B.K. Bachhawat, Department of Biochemistry, Delhi University
developed a cost effective substitute of Ambisome - a US product
• Indian Government's Department of Biotechnology supported the
research
• After pre-clinical work, clinical evaluation carried out in association with
Seth GS Medical College and KEM Hospital Mumbai ,as well as other
reputed hospitals from Mumbai.
• After completion of clinical trials, DBT involved for effecting technology
transfer
21

22. TECHNOLOGY TRANFER
First technology transfer
• Ace Diagnostics and Biotech Ltd. Could not do well due to commercial
reasons
Second technology transfer
• Lifecare Innovations in 1999
• License fee Rs. 25 lakhs and royalty of 3% for 10 years
Further improved the formulation to overcome the doses related toxicities
Support for improvements obtained from DSIR's Program Aimed at
Technological Self Reliance (PATSER) scheme
22

23. TECHNOLOGY COMMERCIALIZATION
Product (Liposomal Amphotericin B) marketed as "FUNGISOME“
Available in various doses thereby reducing wastage and cost ( i.e. less than
1/10th the cost of the imported drugs).
Converts into several small unicellular liposomes, resulting in significantly
increased therapeutic index.
Useful for treatment of Systemic Mycosis, Kala Azar and severe burn injuries
Successfully commercialized
23

24. INTELLECTUAL PROPERTY PROTECTION
The protection prevents third parties using the protected IP in an
unauthorized manner and in case of any unauthorized use provides legal
remedies to prevent the same and claim damages.
ADVANTAGES:
Enhance the market value of your business
Turn ideas into profit-making assets
Market your business products and services
Access or raise finance for your business
Enhance export opportunities for your business
24

25. DISADVANTAGES:
• Increased Intellectual property measures of protection will lead to an
increase in the price of the patented drugs.
• Making them completely inaccessible to people who need them.
25

26. CONCULSION
Transfer technology creates the bridge between R&D and production
as it helps to creating more efficient and safe medications.
Technology Transfer provides an opportunity to reduce cost on drug
discovery and development thus major pharmaceutical companies look
for technology transfer opportunity as it reduces risk, cost and rate of
failure.
 The lack of intellectual property rights protection can affect the nature
of licensing contracts as well as the mode of technology transfer.
26

27. REFERENCES
Denis Business development technology transfer. Technology transfer method. Aug
17 2013.
Kaur Technology Transfer in Pharmaceutical Industry. International Journal of
Current Pharmaceutical Industry,2013; vol 5
International journal of advances in pharmaceutics-
http://ssjournals.com/index.php/ijap
Sharmila vishwasrao . Intellectual property rights and the mode of technology
transfer. Journal of development economics .1994 pg: 381-402
 Intellectual property rights and law 27

28. 28