TECHNOLOGY TRANSFER RESEARCH & DEVELOPMENT TO

PRODUCTION

Minor Project Report

Submitted to

RAJIV GANDHI PROUDYOGIKI VISHWAVIDYALAYA, BHOPAL

(State Technological University of Madhya Pradesh, India)

In partial fulfillment of the requirement for the award of the degree of

BACHELOR OF PHARMACY

Submitted by
Gyanesh Ajit
B.Pharm VII semester

Enrollment No.: 0150PY151031

Under the Guidance of

Mr. G.K. Pandey
Associate Professor, Dept. of Pharmaceutics

TECHNOCRATS INSTITUTE OF TECHNOLOGY – PHARMACY EDUCATION & RESEARCH

ANAND NAGAR , BHOPAL –21. MADHYA PRADESH

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 TECHNOCRATES INSTITUTE OF TECHNOLOGY PHARMACY
EDUCATION AND RESEARCH, BHOPAL

(Approved by AICTE, New Delhi)

(Affiliated to Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal)

CERTIFICATE

This is to certify that the work embodied in this thesis entitled, TECHNOLOGY TRANSFER
RESEARCH & DEVELOPMENT TO PRODUCTION is prepared by GYANESH AJIT
and submitted to R.G.P.V., Bhopal Under my Guidance in the Technocrats Institute of
Technology Pharmacy Education and Research, Bhopal for the partial fulfillment for the degree
of BACHELOR OF PHARMACY under my supervision.

This work is original has not been previously formed the basis for the award of other degree,
diploma, associate ship, fellowship or any other similar title and the dissertation represent
entirely an independent work on the part of the Candidate.

Principal Mr. G. K. Pandey

T.I.T. P.E.R Asst. Professor,

Bhopal Dept. of Pharmaceutics,

Technocrats Institute of Technology
Pharmacy Education and Research Bhopal

Place: Bhopal
Date:

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 TECHNOCRATS INSTITUTE OF TECHNOLOGY PHARMACY
EDUCATION AND RESEARCH, BHOPAL

(Approved by AICTE, New Delhi)

(Affiliated to Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal)

DECLARATION

The work presented in this thesis entitled “TECHNOLOGY TRANSFER RESEARCH &
DEVELOPMENT TO PRODUCTION” was carried out by me at Technocrats Institute of
Technology Pharmacy Education and Research, Bhopal under the supervision of Mr. G. K.
Pandey, Asst. Prof., Dept. of Pharmaceutics, T.I.T.P.E.R, Bhopal. This work is original & has
not been submitted in part or full for the award of other degree or diploma of any other
university.

Place: Bhopal

Date

Gyanesh Ajit
VII Semester
T.I.T.P.E.R, Anand Nagar
Bhopal

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 ACKNOWLEDGMENT

First, I would like to express my salutation to God for giving me the strength, confidence in
moral boost to successful completion of this project.

Numerous people have been instrumental in enabling me to give a concrete shape to my thesis.
However, I must mention the names of few people who have made catalytic impact on the
development of this project.

First and foremost, I would like to acknowledge the continuous encouragement and help
extended to me by Mr. G.K.Pandey sir , for preparing this project. He has been my soul guide
and philosopher throughout the period of my work. His extensive knowledge of the subject and
the way he imparted the same to me has enabled me to develop the thesis in a cohesive manner
and kindled within me a passion for the subject.

I wish to thank Mr. Amit Jain sir for providing the necessary facilities and constant inspiration
throughout my studies of B. Pharm. I take this opportunity to place on record my indepthness to
Mr .Salaj Khare sir for helping me when I needed.

I am also thankful to my parents who lead me from darkness to light, ignorance to enlighten,
confusion to clarity throughout my life.

I am especially thankful to my friends and classmates for their tremendous corporation

throughout my studies.

Date: ……………… Student’s Name: Gyanesh Ajit

Place: Bhopal Enrollment no: 0150PY151031

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 TABLE OF CONTENTS

S. No. TOPICS PAGE No.

1. Background 6
2. Objective 6
3. Scope and Organization 6-7
4. Abstract 8
5. Introduction 9
6. Guidelines/ Importance of Technology Transfer 9-10
7. Reason for Technology Transfer 10
8. Goals of Technology Transfer 10-11
9. Steps in Technology Transfer Process 11-15
10. Factors Influencing Transfer Process 15-18
11. Success of Technology Transfer 19
12. Technology Transfer Success Criteria 20
13. Utilization of Quality by Design Paradigm 20-21
14. A Common Thread to Technology Transfer 21-22
15. Case Study 22
16. Conclusion 23-24
17. Bibliography 25

BACKGROUND-

According to the revised Japanese Pharmaceutical Affairs Law in July 2003, the manufacturing
approval system has been replaced with the manufacturing and marketing approval system in
April 2005, resulting in a big change in the Japanese pharmaceutical system and regulations.
Under these circumstances, it is highly desired to improve a quality assurance system of drugs at

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all stages through research and development (R&D), manufacturing and marketing in line with
the trends by reviewing the current quality assurance system and its methods including existing
Good Manufacturing Practice (GMP) to comply with the new system and adopting achievements
of technological progress and international harmonization of pharmaceutical regulations.
In recent years, there is a growing awareness that an appropriate transfer of
manufacturing technologies (technology transfer) is important to upgrade drug quality as
designed during R&D to be a final product during manufacture as well as assure stable quality
transferred for many reasons between contract giver and contract acceptor during manufacture.
Also, to assure the drug quality, it is desired to make sure 5 W’s and 1 H, that is what, when and
why information should be transferred to where and by whom and how to transfer, then share
knowledge and information of the technology transfer each other between stake holders related
to drug manufacturing. For that purpose, it is necessary to establish an appropriate guideline for
the technology transfer and upgrade the quality assurance system. This guideline categorizes
information generated in the processes through pharmaceutical R&D and manufacturing as well
as the information flows, discusses information necessary for the technology transfer and
communication route, and proposes ideal technological transfer.

OBJECTIVE-
The objectives of this project are:
1) To elucidate necessary information to transfer technology from R&D to actual manufacturing
by sorting out various information obtained during R&D;
2) To elucidate necessary information to transfer technology of existing products between
various manufacturing places; and
3) To exemplify specific procedures and points of concern for the two types of technology
transfer in the above to contribute to smooth technology transfer.

SCOPE-

The study of this project applies to the technology transfer through R&D and production of drugs
(chemically synthesized drug substances and drug products) and the technology transfer related

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to post-marketing changes in manufacturing places. The both technologies include those of
manufacturing and quality control (manufacturing methods and tests).

ORGANIZATION-
This project consists of the followings:
• Explanation of technology transfer process
• Explanation of procedures and necessary documents for technology transfer
• Examples of technical information to be transferred
• Points of concern for documenting technology transfer

ABSTRACT

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In today’s business setting, interest in the profitable exploitation of a firm’s technological assets,
through technology transfer, has intensified. Factors that have facilitated international technology
transfer include globalisation of business, liberalisation of the economic regimes of many
countries, and the impetus given to the protection of intellectual property after the formation of
the World Trade Organization (WTO). These factors have collectively resulted in commercial
transfer of technology becoming an important element of the international business setting.
Experience over the decades has shown that the technology transfer process can be problematic
and transferees often lack the skills to manage it effectively. While the literature is rich in terms
of the coverage of the areas of concern it is sparse when it comes to possible approaches that can
be taken to remedy these problems. Appropriate technology transfer is both vital and critical to
drug discovery and development for novel medicinal products and is also essential to upgrade
drug quality intended during research and development and to finishing product during
manufacturing as well as to assure constant quality transferred. Successful growth and
commercialization of innovative technologies is always apprehensive with difficulties,
multifaceted endeavour, and a range of development tools exist to uphold this activity, by far the
most popular approach to directly supporting successful innovation is through technology
transfer. To develop appropriate clinical good manufacturing practice facilities, specify and
design specialized process equipment, finalize process details, and correctly determine scale-up
parameters requires the integrated efforts of a highly skilful technology transfer team. Successful
technology transfer requires carefully studying conditions like careful evaluation of ultimate
manufacturing requirements early in research and development and the consequent improvement
of robust developments that endure large-scale operation, the assembly of a detailed technology
transfer document that provides manufacturing with both “know how” and “know why,” and will
serve as the basis for facilities and equipment design as well as operator training and standard
operating procedure generation in successful manufacturing.

INTRODUCTION-

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What is Technology Transfer
Transfer of technology is defined as a “logical procedure that controls the transfer of any process
together with its documentation and professional expertise between developments or between
manufacture sites.”
 Technology transfer is both integral and critical to the drug discovery and development
process for new medical products.
 Technology transfer 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. It is the process by which by an original
innovator of technology makes it technology available to 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.
 Technology transfer is important for such researcher 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.

FACTS OF TECHNOLOGY TRANSFER-

The transfer of technology could happen in following ways-
 Government labs to private sector firms.
 Between private sector firms of same country.
 Between private sector firms of different country.
 From academia to private sector firms.

GUIDELINES/ IMPORTANCE OF TECHNOLOGY TRANSFER-

 To elucidate necessary information to transfer technology from R&D to actual
manufacturing by sorting out various information obtained during R&D.
 Demonstration of necessary information to technology transfer from research and
development to actual manufacturing.

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  To elucidate necessary information to transfer technology of existing products between
various manufacturing places.
 To exemplify specific procedures and points of concern for smooth technology transfer.
For the smooth manufacturing of commercialized products.

REASON FOR TECHNOLOGY TRANSFER-

 Due to lack of manufacturing capacity:- The developer of technology may only have
manufacturing equipment which is suitable for small scale operation, and must
collaborate with another organization to do large scale manufacturing.
 Due to lack of marketing distribution and distribution capability.
 Due to lack of resources to launch product commercially.
 Forming alliances with partners.
 Forming alliances with partners with marketing and distribution capability.
 Exploitation in a different field of application: - Each partner may have only half of the
solution i.e. the developer of the technology might be capable of exploiting the
technology itself in the field of diagnostic applications and may grant exploitation right to
commercial partner for the exploitation of therapeutics application.1

GOALS OF TECHNOLOGY TRANSFER-2

 Is a valuable step in the developmental life cycle leading to successful commercial
manufacturing of drug in drug product development life cycle.
 To take all the gathered knowledge and use it as the basis for the manufacturing control
strategy, the approach to process qualification and on-going continuous improvement.
 The transition of the product/process/analytical method knowledge between development
and manufacturing sites.

1
Patil RP. Technology Transfer in Pharmaceutical Industry: objectives, Issues & Policy
Approaches, Int. J Pharm. Res. Dev. 2010; 2(10):43-48.
2
Patil R. Technology Transfer in Pharmaceutical industry : Objective, Issue, and Policy
Approach International Journal of Pharamceutical Research and Development. 2(10): 43-48
(2010).
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  To ensure variability of process and parameters are controlled and sufficient in the face of
the rigors of a commercial production environment to verify parameters established
during development are still within the determined design space and/or adjusted at scale-
up.

STEPS IN TECHNOLOGY TRANSFER PROCESS-

Technology Transfer is not a single way process. The development of new formulation goes
through many stages. During development of a formulation, it is important to understand
procedure of operations used, critical and noncritical parameters of each operation, production
environment, equipment and excipient availability, which should be taken into account during
the early phases of development of formulation, so that successful scale up can be carried out.
Appropriate care during technology transfer is important to enhance drug quality as developed
by R&D in final formulation as well as to assure quality for predetermined period of time. 3 The
processes are classified into the three categories:

The different steps after the Drug Discovery, Different Phases Before Approval, and
Different Kind of Regulatory Approvals in the Launch of New Medicinal product in the
Regulatory Country

3
Gorman ME. Types of knowledge and their roles in technology transfer. Journal of Technology
Transfer. 2002; 27:219-231.
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  Research phase,
 Development Phase
 Production Phase.
 Research phase (Development of technology by R&D).

1. Quality Design- For drug products the quality design resembles to pharmaceuticals
design to design properties and functions such as-
 Abolition of adverse reactions,
 Enhancement of efficacy,
 Assurance of stability during delivery and
 Data based on various data such as chemical and physical properties, efficacy,
safety and stability obtained from preclinical studies.
For drug substance the quality design is to define starting materials and their reaction paths and
basic specification of the drug.

DEVELOPMENT PHASE-
1. Research for factory production-
For manufacturing drugs with qualities as designed, it is necessary to institute suitable quality
control method and manufacturing method, after identifying unevenness factors to secure
stability in the scale up (validation) that is executed to realize factory production of drug
designed on the basis of result from small scale experiments.

2. Consistency between Quality and Specification-

 When product specification is established on the basis of the quality of the product
determined in the above, it is essential to validate that the specification adequately
stipulates the product quality.4
 Relations between upper and lower limits of manufacturing formula (composition and
manufacturing methods) and upper and lower of control limits of the product specification
4
Patel DS, Nadiad. Technology Transfer an Overview of Pharmaceutical Industry. Int Biopharm
Association Publ. 2009; 2(4):2-8.
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should be fully understood, and the consistency between the product quality and specifications
should be maintained.
 In short, the consistency between quality and specification is to ensure in the products
specification that the quality predetermined in the quality design is assured as the manufacture
quality, and the product satisfies the quality of design.

1. Assurance of Consistency through development and manufacturing-

 For this purpose, the transferring party in charge of development should fully understand
what kind of technical information is required by the transferred party in charge of
manufacturing and should establish an appropriate evaluation method to determine
whether a drug to be manufactured meets the quality of design.
 For stable production of consistent products, it is fundamental to fully refer to
information of similar products of the past maintained by the manufacturer when research
for factory production is implemented.

2. Technology Transfer from R & D to Production-

R&D provides technology transfer dossier; TTD document to product development
laboratory; PDL, which contains all information of formulation and drug product as given
below:
 Master formula card, MFC: It includes product name along with its strength, generic
name, MFC number, page number, effective date, shelf life and market.
 Master packaging card: It gives information about packaging type, material used for
packaging, stability profile of packaging and shelf life of packaging.
 Master formula: It describes formulation order and manufacturing instructions.
Formulation order and Manufacturing Instructions gives idea of process order,
environment conditions required and manufacturing instructions for dosage form
development.
 Specifications and standard test procedure; STPs: It helps to know active ingredients
and excipients profile, in- process parameters and specifications, product release
specification and finished product details.

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PRODUCTION PHASE-
1. Validation & Production-
 Production is implemented after various validation studies verify that it is able to stably
product based on transferred manufacturing formula.
 While the manufacturing facility accepting technology is responsible for validation, the
research and development department transferring technology should take responsibility
for validation such as performance qualification; PQ, cleaning validation, and process
validation; PV unique to subject drugs.

Scale Up for Production-

Scale up involves the transfer of technology during small scale development of the product and
processes. It is essential to consider the production environment and system during development
of process.5 Operators should concentrate on keeping these things in mind that their segment of
the production process running smoothly if technology transfer is implemented thoughtfully.
Effective technology transfer helps to provide process efficiency and maintain product quality.

Feedback from Production and Technology Transfer of Marketed Product-

 To accumulate technical information obtained from repeated production.
 The information of modify various standards.
 The improvement of process and products.
 The changes of specifications and methods.
 The technical information of reviewed and updated at regular intervals.
 Establish of adequate Feedback system.

Exhibit Batches-
After taking scale up batches of the product, manufacturing of exhibit batches takes place. In
case of exhibit, batch sizes are increased along with equipment’s and their processes. This is
done for filling purpose in regulatory agencies. The Purpose behind to run three consecutive
5
Gibson M. Pharmaceutical Preformulation and Formulation: A Practical Guide form Candidate
Drug Selection to Commercial Dosage Form, Interpharm/CRC Press, A division of Taylor and
Francis Books Inc, FL, USA, 2001
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batches are to shows process consistency, reproducibility and to demonstrate that the
manufacturing process is under control throughout all the stages.

FACTORS INFLUENCING TECHNOLOGY TRANSFER-

A. Drivers for Technology Transfer-6
 Good business and manufacturing practices: The Company’s success is primarily the
result of its adoption of good business and manufacturing practices, particularly in the
areas of product identification and formulation technology.
 Potential for competitive pricing: Balance cost to remain competitive by having higher
private sector prices and very low public sector prices.
 Strategic planning: Create an enabling environment for vertical integration, with
prospects for higher capacity utilization and eventual lowering of production costs.
 Promising market scale and accessibility: While it is not easy to define the market size
or type that will make for viable economic production, it is generally the case that, the
larger the country or geographic bloc, the greater the market potential and investment
appeal.
 Adherence to regulatory standards: The pharmaceutical industry is one of the most
heavily regulated, to ensure quality, safety and efficacy of its medicines and the well-
being of patients. The ability to meet international regulatory standards, or at least those
of the major markets, is a precondition for many technology transfer activities.
Regulations and standards apply also in low- and middle-income countries. For example,
governments require product registration and data submissions to demonstrate quality,
safety and efficacy.
 Skilled workforce: Human capital is an essential element of the technology transfer
process. The successful absorption of technology or know-how in the recipient country
and its translation into greater economic development hinges on the availability in the
host country of an educated workforce with, for example, engineering and management
skills.

6
Donald. Transfer of Process from Development to Manufacturing. Drug Information Journal.
1998; 32:19- 26.
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  Innovation- friendly environment with sound Intellectual Property Protection and
Enforcement: To successfully attract imported technology and to build the necessary
preconditions for adapting imported technology, countries need a supportive environment
that includes strong intellectual property protection and enforcement. Effective
enforcement of any intellectual property laws and regulations already in force provides
transparency and certainty for investors, licensees and customers. The level of intellectual
property protection tends to be directly and positively linked to the rate of technology
transfer.
 Proper access to information or increased information exchange: Where adequate
intellectual property systems are in place, attention should be given to supporting access
to information. This has a number of dimensions, from better documentation of available
resources, to the longer-term issue of addressing the complexity of the global knowledge
market. In the absence of effective systems for disseminating market-relevant
information, technology-holders may find it difficult to identify precisely who is
interested in purchasing their technology, while technology-demanders face a similar
challenge in finding entities willing to transfer their technology.
 Opportunities for contingency supply: Multinational pharmaceutical companies are
inclined to transfer technology to local manufacturers with the potential to receive when
they foresee an inability to meet time scales and volume demand from large procurers.
 Access to new machinery, training, know-how and business partnership: This makes
the prospect of technology transfer very desirable to local pharmaceutical manufacturers
since the technology, equipment, etc. could be applied profitably beyond the initial
purpose.7

B. Barriers of Technology Transfer-8

 Lack of awareness knowledge and efficiency: Automation of manufacture processes to
improve efficiency and lower costs.

7
Akhavan A. Technology Transfer to Developing Countries: The Iranian Experience
8
Ortega AJ, Arce NA, Sequeda F, Gribenchenko I. Management of Innovation and Technology
Transfer Process Between University and Industry.
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  Lack of government focus low market share: Local producers face significant
challenges in meeting International Quality Standards and capturing a critical market
share. Greater market share would increase profitability.
 Web access and scientific publication: Restricted access to scientific journals directed
to massive complications for developing nation’s scientists.
 Cost of prequalification: There is profit in meeting International Standards since it
opens up the opportunity for trading across the entire world.
 National security issues and restrictions on exports of particular technology:
International controls designed to protect national security and to prevent the
proliferation of important technologies also restrict the flow of technologies.
 Inadequate funding in important areas and possible treaties: There are areas of
research of importance to the developing world that are being funded inadequately.
 Labour issues: The pharmaceutical sector demands relatively skilled labour. High labour
turnover and absenteeism owing to unattractive conditions of service is negative
contributor.9

C. Approaches to overcome barriers in technology transfer-10

 Commercializing publicly funded technologies: The basic pattern envisioned is to give
institutions receiving public research funds the right to obtain and exploit patents on
inventions developed in the course of research.
 Political stability and good transparent governance: A country’s relative political and
economic stability will influence the rate of inward technology transfer and can be seen
as a pre-condition for any technology transfer. Even when research-based pharmaceutical
company technology transfers are benevolent in nature, they need to be sustainable in
order to achieve their goals. Political leadership is critical to address global and local
health challenges and, more importantly, healthcare system capacity strengthening.

9
Godkin L. Problems and practicalities of technology transfer: a survey of the literature.
International Journal of Technology Management. 1988; 3(5):587-603.
10
Madu CN. Transferring technology to developing countries – Critical factors for success. Long
Range Planning. 1989; 22(4):115-124.
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  Research tool patents and freedom to operate for the public sector: Patents
sometimes make it difficult for public researchers to carry out their research or to make
the products of that research available. It is intensified by the tendency of some publicly
funded research laboratories to avoid use of a patented technology without permission
even in nations where no relevant patent is in force.
 Appropriate Capital Markets: For many governments seeking to expand technological
capacity, attracting direct investment is very important, but there is also a question of
making the most of the spillover benefits of investment. This can reveal a need for
adequate capital markets. Governments can also promote inward investment through tax
breaks and other forms of incentives designed to encourage technology transfer, in
compliance with international trade rules.
 Alignment with Economic Development Priorities: The finite or limited resources
available to governments imply that measures taken to promote technology transfer need
to both be realistic and to fit with overall policy goals. A technology transfer policy
dedicated to the creation of completely new types of economic activity and one which is
as complex and as highly regulated as the pharmaceutical sector can present a much
bigger challenge than building on a sector that already exist.
 Co-operative research agreements: Global support for public sector research might be
encouraged is through cooperative research agreements designed to meet specific goals.
It would seem more feasible to focus efforts on technologies of significant social benefit
to the developing nations.
 Possible treaty on scientific access: There has also been a proposal for an international
treaty on access to knowledge and technology negotiated on the basis of the type of
reciprocity found in normal international trade negotiations. The concept is mean to be
non- zero sums in the sense that, like free trade in goods, free trade in scientific ideas
benefits all and such arrangements could be made bilaterally as well as multilaterally.

SUCCESS OF TECHNOLOGY TRANSFER-

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The different “C” for successful technology transfer is: Communication, Certainty, Challenges,
Capacity and Commitment11
 Communication: The technology transfer chain is often long, in terms of both distance
and time. Effective communication is thus another essential ingredient in the recipe for
successful technology transfer. Efficient and effective two way communication and
corporation between key stakeholders will do much to remove barriers.
 Certainty: A lack of certainty, and the consequential high levels of risk, both real and
perceived, are recognized a major impediments to the successful establishment and
ongoing operation of functional markets. Removing barriers to technology transfer often
translates into increased certainty, and decreased risk, for the key stakeholders such as
developers, suppliers and recipients.
 Challenges: There are many barriers to successful technology transfer. All along the
transfer path, from the supply side of technology to demand side, impediments occur at
very node and, due to restrictions on movement of information and materials, for every
linkage in technology transfer chain.
 Capacity: Enhancing the transfer of technologies that support sustainable development in
largely about creating favourable circumstances for technology transferensuring all
stakeholders have the ability to fulfil their roles and meet their responsibilities,
expeditiously. All key players and stakeholders must have the necessary knowledge and
skills to perform the roles and tasks expected of them.
 Commitment: For a successful technology transfer there may be a good commitment to
overcoming the challenges, providing technology users with the choice they deserve and
desire, increase certainty, reducing risks, enhancing the communication between
technology transfer stakeholders and building and strengthening the enabling
environment and thus the capacity for technology transfer.

TECHNOLOGY TRANSFER SUCCESS CRITERIA12-

11
Patil RP. Technology Transfer in Pharmaceutical Industry: objectives, Issues & Policy
Approaches, Int. J Pharm. Res. Dev. 2010; 2(10):43-48
12
George P. Scale Up and Technology Transfer as a Part of Pharmaceutical Quality System.
Senior Director Pharmaceutical Commercialization Development .ICH Conference Merk. (2011)
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  To success the given technology transfer the data should be match with the flow of
procedure in formulation and production department.
 All the process and control parameter should be stated at given set of procedure.
 To develop the drug the material supplier should be with their Certificate of Analysis.
Health, safety and environmental concerns. Compliance with all registered commitments.
 Technology Transfer must also be completed :
-Safely -The process being transferred runs as expected (yield, purity, cycle time, etc.)
-On time (product launch) -On budget -No “CRISIS” situations.
 For the success of technology transfer the Communication should be :
Open communication between all team members.
Direct communication between the technical members.
Effectively and timely communication with the technical and non technical members.

UTILIZATION OF QUALITY BY DESIGN PARADIGM TO ENSURE TECHNOLOGY

TRANSFER-
Quality by Design (QbD) refers to a holistic approach towards drug development. QbD has
become the answer to assist both industry and FDA to move towards a more scientific, risk
based, holistic and proactive approach to pharmaceutical development. The concept promotes
industry’s understanding of the product and manufacturing process starting with product
development, basically building quality in, not testing it. This systematic approach to product
development and manufacturing has received a great deal from traditional approach, which was
extremely empirical. Implementation of QbD is enabling transformation of the chemistry,
manufacturing, and controls (CMC) review of Abbreviated New Drug Applications (ANDAs)
into a modern, science and risk based pharmaceutical quality assessment.

Quality By Design Works for Technology Transfer like:

 Form a diverse/skilled and collaborative development team.
 Review process flow diagram for key inputs/outputs that could impact quality (QRM).
 Uni/multi variant experiments should have been completed to study relationships and
gain information on potential sources of variability. (Need to know where quality could
be impacted).

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  Make sure you understand your measurement capability (i.e. repeatability, precision).
 Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs) and other
important parameters are identified.
 Design space should be defined and understood consisting of a set of input ranges (CPPs)
that provide high probability that CQAs will meet specification.
 A control strategy needs to be in place to assure focus on critical points.

A COMMON THREAD TO TECHNOLOGY TRANSFER-

The Q10 glossary defines the Pharmaceutical Quality System (PQS) as a “management system to
direct and control a pharmaceutical company with regard to quality.” The guideline introduction
states that “ICH Q10 is not intended to create new expectations beyond current regulatory
requirements.
“The change management system should provide management and documentation of
adjustments made to the process during technology transfer activities.” “Aspects of management
review should be performed to ensure the developed product and process can be manufactured at
commercial scale.”
Management Review of Process and Product Quality
Management review should provide assurance that process performance and product quality are
managed over the life cycle. Depending on the size and complexity of the company, management
review can be a series of reviews at various levels of management and should include a timely
and effective communication and escalation process to raise appropriate quality issues to senior
levels of management for review.

SCOPE OF TECHNOLOGY TRANSFER IN VARIOUS FIELDS-

 Department of Agriculture (USDA)
 Department of Commerce (DOC)
 Department of Defence (DoD)
 Department of Energy (DOE)
 Department of Health and Human Services (HHS)
 Department of Homeland Security (DHS)

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  Department of the Interior (DOI)
 Department of Transportation (DOT)
 Department of Veterans Affairs (VA)
 Environmental Protection Agency (EPA)
 National Aeronautics and Space Administration (NASA)
- All this department has a application of technology transfer such as incase of Department of
Health and Human Services (HHS)

CASE STUDY-
New Live Attenuated Vaccine Against All Four Types Of Dengue Infection (CDC)
Vaccine discoveries at the CDC have formed the basis for a new live attenuated dengue fever
vaccine. Dengue fever and dengue hemorrhagic fever are viral diseases that are among the most
significant viral illnesses transmitted by mosquitoes to humans worldwide. Over 2.5 billion
people, including travelers, are at risk of contracting dengue illness in countries in tropical
regions of the world. The case fatality rate for dengue infections is about 5% in most countries,
with most fatal cases occurring among children and young adults. This new vaccine discovery,
along with new safety assays for it, has been licensed to a small biotechnology company for
manufacture and testing in humans. The license agreement was completed by the CDC Office of
Technology Transfer with a goal of bringing a safe and effective tetravalent dengue vaccine to
save millions of lives and decrease the economic burdens cause by dengue disease.

CONCLUSION-
Technology transfer is an active and essential mission of Research and Development Department
of the Innovative Company. By leveraging our nation’s innovative nature and investing in
science and technology, we strengthen our economy and competitiveness in world markets. In
pharmaceutical industry, technology transfer means action to transfer of information and
technologies necessary to realize quality of design of drugs during manufacturing. The three
primary considerations to be addressed during an effective technology transfer are the plan, the
persons involved, and the process. Technology transfer can be considered successful if a
receiving unit can routinely reproduce the transferred product, process or method against a
predefined set of specifications as agreed with a sending unit and/or a development unit. To

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assure the drug quality, it is desire to make sure that is what, when, and why information should
be transferred to where and by whom and how to transfer, then share knowledge and information
of the technology transfer each other between stake holders related to drug manufacturing
.Sharing industrial new innovative techniques forms the best sharing platform which helps to
avoid the deformities in the novel approaches of the industries.

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 utilise
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. A cooperative effort by team
results in more successful initial and consistency runs leading to an earlier license, earlier launch
and a greater market share. 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. A dedicated technology transfer organization is set
up to facilitate and execute the process. Technology transfer can be considered successful if a
receiving unit can routinely reproduce the transferred product, process or method against a
predefined set of specifications is agreed with a sending unit and/or a development unit.
Licensing is an imperative spectacle of technology transfer that has gained momentum in
pharmaceutical industry by which pharmaceutical firms can contribute to research and
development. Technology transfer is a complex issue and should be deal with using holistic
approach.

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BIBLIOGRAPHY-
References-
1. Mahboudi M, Ananthan BR. Effective factors in technology transfer in the
Pharmaceutical industries of Iran: A Case Study. The IUP Journal of Knowledge
Management. 2010; 8(1, 2):99.
2. Bendis R, Byler E. Creating a National Innovation Framework, Building a Public-Private
Support System to Encourage Innovation. Science progress, 2009.
3. Reamer A, Icerman L, Youtie J. Technology Transfer and Commercialization: Their
Role in Economic Development, 2003, 10-16.

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 4. Feifei YUE, Yigming YUE. Research on Technology Transfer in the Pharmaceutical
Industry, Technology Transfer Journal of Tongji University. Natural Science. 2008, 11-
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5. Steenhuis HJ, De Boer SJ. Differentiating between types of technology transfer: the
technology building. International Journal of Technology Transfer and
Commercialization. 2002; 1(1-2):187-200.
6. Ghafaripour A. Fundamental Concepts for Technology Transfer Process, Industries
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7. Gupta. Technology Transfer in pharmaceutical industry: An overview. Novel Science
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