Dogra et al., IJPSR, 2013; Vol. 4(5): 1692-1708.

ISSN: 0975-8232

IJPSR (2013), Vol. 4, Issue 5 (Review Article)

Received on 12 January, 2013; received in revised form, 28 February, 2013; accepted, 29 April, 2013

TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY: TRANSFER OF PROCESS

FROM DEVELOPMENT TO COMMERCIALIZATION
Rahul Dogra*1, Rajeev Garg 1 and Prabhash Jatav 2
Department of Pharmaceutics, Amar Shaheed Baba Ajit Singh Jujhar Singh Memorial College of Pharmacy 1,
Punjab, India
Ranbaxy Laboratories Limited 2, Himachal Pradesh, India
Keywords: ABSTRACT: Appropriate technology transfer is both integral and
Technology transfer, Drug Discovery, critical to drug discovery and development for new medicinal products
Development, Scale-up, Technology and is also important to upgrade drug quality designed during research
Transfer Document, Commercialization
and Pharmaceutical Industry and development and to final product during manufacturing as well as to
assure stable quality transferred. Successful development and
Correspondence to Author: commercialization of innovative technologies is always fraught with
difficulties, multifaceted endeavour, and a variety of development tools
Rahul Dogra exist to promote this activity, by far the most popular approach to
Department of Pharmaceutics, Amar directly promoting successful innovation is through technology transfer.
Shaheed Baba Ajit Singh Jujhar Singh To successfully and simultaneously develop appropriate clinical good
Memorial College of Pharmacy, Punjab, manufacturing practice facilities, specify and design specialized process
India equipment, finalize process details, and correctly determine scale-up
parameters requires the integrated efforts of a highly skilled technology
E-mail: [email protected]
transfer team. Successful technology transfer requires carefully studying
QUICK RESPONSE CODE numerous situations like careful evaluation of ultimate manufacturing
IJPSR:
ICV (2011)- 5.07
requirements early in research and development and the consequent
development of robust processes that withstand large-scale operation,
Article can be the assembly of a detailed technology transfer document that provides
accessed online on: manufacturing with both “know how” and “know why,” and will serve
www.ijpsr.com as the basis for facilities and equipment design as well as operator
training and standard operating procedure generation and the
management of a closely integrated and cooperative technology transfer
team with membership from development, manufacturing, engineering,
quality, validation, and management to ensure that the new process is
carefully and thoroughly taught to all involved, that fine details as well
as broad objectives are clearly in focus until the new process is through
consistency lots and in successful manufacturing.
SCIENCE, TECHNOLOGY, PRODUCT, Apparently there are professional definitions for this
INNOVATION AND COMMERCIALIZATION: word, but all have common aspects. There are
Science is knowledge regarding certain principles of different aspects for technology.
nature. Technology is defined differently.
Sociologists, economists, management scientists and Cultural Aspect: It contains goals, values, morals,
other faculties have their own definitions of beliefs, awareness and creativity.
technology.

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Organisational Aspect: It includes industrial, systems and collectives or it is the ability to take new
economical, professional and technical activities, ideas and translate them into commercial outcomes
users, customers and commercial unions. by new processes, products or services 2.
Technical Aspect: Knowledge, skills, techniques, Commercialization is the process of transforming
tools, machineries, sources, and production are new technologies into commercially successful
considered as technology. products. The commercialization process includes
such efforts as market assessment, product design,
Therefore Technology is the application of manufacturing engineering, management of
engineering to science, the use of our understanding intellectual property rights, marketing strategy
of nature to develop a technical method for achieving development, raising capital, and worker training.
a practical purpose 1. Typically, commercialization is a costly, lengthy
process with a highly uncertain outcome. The costs
Product is the application of technology in a
of commercialization can run from between 10 and
particular physical form designed to carry out a
100 times the costs of development and
specific set of functions. Innovation in the context
demonstration of a new technology. Moreover,
of technology companies, can be defined as “a
success is rare, less than five percent of new
complex process that takes place at the level of
technologies are successfully commercialized 3. Even
specific products, businesses and sectors, as well as
when successful, technology commercialization does
at the level of our national and international
not happen quickly. Commercialization of radically
community’s” (Smits 2002: 865) that generate
new technologies can take well over a decade as
technical artefacts, processes and sociotechnical
shown in figure 1.

FIG. 1: ILLUSTRATES THAT TECHNOLOGY TRANSFER FLOW IS NON LINEAR, INVOLVES DIFFERENT
STAGES AND DOES NOT HAPPEN QUICKLY, TAKES MORE TIME OVER A DECADE

LITERATURE OF TECHNOLOGY TRANS In a similar vein economists such as Arrow (1969)

FER: Based on a review of literature, technology and Dosi (1988) have analysed technology transfer
transfer is not a new business phenomenon or not a on the basis of the properties of generic knowledge,
new thing. During the colonial era, technology focusing particularly on variables that relate to
transfer by colonial powers to production entities in product design.
their colonies was mainly in the primary sector such
as mining, plantation and agriculture (Ramanathan The term technology transfer can be defined as the
1989). process of movement of technology from one entity
to another (Souder et al. 1990; Ramanathan 1994).
Those transfers were aimed at the development of
methods and techniques in order to obtain the The transfer may be said to be successful if the
maximum output in export industries such as mining receiving entity, the transferee, can effectively utilize
and plantation agriculture and the development of the technology transferred and eventually assimilate
infrastructure for such industries. it (Ramanathan, 1994).

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In a very restrictive sense, where technology is in the classic description of the process to
considered as information, technology transfer is commercialization, market adoption and uptake
sometimes defined as the application of information (Bozeman 2000).
into use (Gibson & Rogers 1994).
Sociologists such as Rogers, Shoemaker (1971) and
The transfer may be said to be successful if the Rogers (2003) have defined technology transfer in
receiving entity, the transferee, can effectively utilize the context of diffusion of innovations. This has led
the technology transferred and eventually assimilate to confusion where many researchers and even
it (Ramanathan, 1994). practitioners, refer to the terms technology transfer
and technology diffusion interchangeably. The
The considerable literature on technology transfer literature on technology diffusion, in general,
that has emerged over the years agrees that defining suggests that the term refers to the spreading, often
technology transfer is difficult due to the complexity passively within a specific technological population,
of the technology transfer process (Robinson 1988; of technological knowledge related to a specific
Spivey et al. 1997). innovation of interest to that population. Technology
transfer, on the other hand, is a proactive process to
Mittleman and Pasha (1997) have attempted a
disseminate or acquire knowledge, experience and
broader definition where they state that technology
related artefacts (Hameri 1996).
transfer is the movement of knowledge, skill,
organisation, values and capital from the point of Furthermore, it is intentional and goal-oriented but
generation to the site of adaptation and application. not a free process (Autio and Laamanen 1995).
Transfer also presupposes agreement and therefore
The definitions depend on how the user defines
involves agreement, unlike diffusion (Ramanathan
technology and in what context (Chen 1996;
1991; Hameri 1996) 3-4.
Bozeman 2000). The movement may involve
physical assets, know-how, and technical knowledge Based on the above literature discussion,
(Bozeman, 2000). Technology transfer has also been Commercial Technology Transfer may be defined as
used to refer to movements of technology from the a mutually agreed upon, intentional, goal oriented
laboratory to industry, developed to developing and proactive process by which technology flows
countries, or from one application to another domain from an entity that owns the technology (the
(Philips 2002). transferor) to an entity seeking the technology (the
transferee). The transfer may be said to be successful
Technology transfer in some situations may be
if the transferee can successfully utilize the
confined to relocating and exchanging of personnel
technology for business gains and eventually
(Osman-Gani 1999) or the movement of a specific
assimilate it.
set of capabilities (Lundquist 2003) 4.
In general, Technology Transfer is the practice of
It may be useful to examine the distinction between
transferring scientific findings from one organization
technology transfer and technology diffusion. The
to another for further development so that new
terms technology transfer and technology diffusion
products such as medicines, educational tools and
appear in the business and technology literature and
health services so that they can become available to
are used interchangeably at times. There is some
the public and by which basic science research and
difference between the two terms between the
fundamental discoveries are developed into practical
European context and the North American and this
and commercially relevant applications and products.
literature review will respect which term is used in
the original article discussed in the annotation. The In Pharmaceutical Industry, technology transfer
sociological literature, which draws a more direct refers to the processes that are needed for successful
link to Rogers' work ([1962] 2003; 1976) refers to progress from drug discovery to product
the diffusion of innovation. Innovation diffusion development to clinical trials to full scale
broadly describes the process whereby a product or commercialization as shown in figure 2 or it is the
service and the knowledge of its use and application process by which a developer of technology makes
moves from a source, such as a research and its technology available to commercial partner that
development domain to a point of reception leading will exploit the technology 8.

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FIG. 2: ILLUSTRATES THE FLOW OF STAGES INVOLVES AFTER RECEIVING THE TECHNOLOGY FROM R&D
TO PDL TILL COMMERCIALIZATION OF THAT TECHNOLOGY IN A PHARMACEUTICAL INDUSTRY

CLASSIFICATION OF TECHNOLOGY Material transfer refers to the transfer of a new

TRANSFER: The work of Hayami, Ruttan (1971) material or product while Design transfer
and Mansfield (1975) provide some of the earliest corresponds to the transfer of designs and blueprints
insights on the modes of technology transfer which that can facilitate the manufacturing of the material
are of relevance even today. or product by the transferee 11.
Mansfield (1975) classified technology transfer into Capacity transfer involves the transfer of know
vertical and horizontal technology transfer. why and know-how to adapt, and modify the
material or product to suit various requirements.
Vertical transfer refers to transfer of technology While Hayami and Ruttan focused on Agricultural
from basic research to applied research to technology transfer, Mansfield emphasised
development and then to production respectively. Manufacturing technology.
Horizontal transfer refers to the movement and use DRUG DISCOVERY, DEVELOPMENT
of technology used in one place, organisation, or PROCESS AND TECHNOLOGY TRANSFER:
context to another place, organisation, or context. Technology transfer is a process to transfer
information and technologies necessary to
Souder (1987) refers to the former as internal
manufacture quality drug product consistently or
technology transfer and the latter as external
technology transfer is the process of taking an
technology transfer. Souder further elaborates upon
invention from its inception in a laboratory to a
vertical technology transfer as a managerial process
commercialized product. The successful technology
of passing a technology from one phase of its life
transfer from R&D, the transferring site, to the
cycle to another. This elaboration is valuable because
commercial production site, the receiving site, is a
it serves to reinforce the fact that it may be possible
critical process in the development and launch of a
to horizontally transfer technology at any stage of the
new medicinal product. It can be extremely costly for
technology life cycle. Hayami, Ruttan (1971) and
a company if things go wrong during the transfer
Mansfield (1975) refer to Material transfer, Design
process, resulting in delays to launching a new
transfer, and Capacity transfer 5.
product on the market and lost sales.

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Also, it can take increased resource, time and cost to efficacy and safety obtained from various studies in
make corrective actions following an unsuccessful preclinical phases and data concerning efficacy,
transfer. safety and stability of drug products obtained from
clinical studies.
Progressive pharmaceutical companies are therefore
placing more attention to streamlining and Phase I clinical studies involve small scale studies in
optimising their technology transfer process to patients and these are often provided for in the form
ensure the rapid and successful introduction of a new of a simple non-optimized formulation, quite
medicinal product to market. Generally the cost of different from the intended commercial formulation,
product development raises dramatically during the because time for development and availability of
pilot scale-up and initial production batch efforts. In drug are limiting factors at this stage. There is a high
other words, the critical path for success is dependent probability that the project will be terminated during
on completion of the technology transfer to the Phase I due to toxicity findings or clinical findings
production site at an affordable cost 6. (safety, efficacy and pharmacokinetics/bioa-
vailability). If unwanted or unexpected effects are
The process of technology development and observed, the programme will most likely be stopped
commercialization takes place over three broad and the project goes back to the research group to try
phases- The development of new science, the and find another lead compound. Alternatively, if the
conversion of science to technology and the outcome is positive, the Candidate Drug; CD may be
conversion of technology to products. The drug progressed to full development as shown in figure 3.
quality is designed based on basic data concerning

FIG. 3: ILLUSTRATE THAT FOR A RESEARCH BASED PHARMACEUTICAL COMPANY, DRUG DISCOVERY
AND DEVELOPMENT CAN BE BROKEN INTO DISTINCT STAGES. FIGURE ILLUSTRATES THE LATTER STAGE
OF THE „RESEARCH‟ OR „DRUG DISCOVERY‟ PHASE AND THE „DEVELOPMENT‟ STAGES LEADING TO NEW
PRODUCT LAUNCH

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Full development involves the completion of longer- If clinical batches of Drug Product are being
term safety and clinical studies (Phase II and Phase manufactured under replicated conditions during the
III) in larger groups of patients (hundreds to latter stages of development, e.g., Phase III, even if
thousands) suffering from the disease. During full still at the R&D site, the regulatory authorities will
development, the synthetic route for the Drug expect that some process validation will have been
Substance; DS is optimized and the manufacturing undertaken. Once the commercial manufacturing
process scaled up and fixed. Larger scale batches of process has been transferred from R&D to
drug substance will be required to support larger Production, the process must be validated to meet
safety and clinical studies and also to support the regulatory requirements if an MAA or NDA is
pharmaceutical development work to optimize the progressed as shown in figure 4.
formulation and Drug Product; DP manufacturing
process. If sufficient Drug Substance is available and Once the Phase III clinical trials are completed
the Phase III supplies are very large, it may be successfully and the Drug Substance; DS, Drug
preferable to scale-up the manufacturing process to Product; DP and analytical methods have been
production scale and transfer the process to the transferred to the intended production sites, a
commercial production site to make the Phase III regulatory submission can be made. Pending
supplies from there 7. approval of the submission and a successful Pre-
Approval Inspection (required if the product is
One potential downside of transferring early to intended for the United States), the new product can
production is that all the development work has to be be launched on the market.
completed earlier in the development programme to
fix the formulation and manufacturing process and After above discussion it can be concluded that
this puts the pharmaceutical development on the technology transfer; TT is the transfer of the
critical path. It is possible to make further changes manufacturing process for a new pharmaceutical
after transferring the process to production, but these Drug Substance; DS and Drug Product; DP
are more difficult and involve documented change respectively from the transferring site (in this case
control. Starting the technology transfer prior to the R&D) to the receiving site or designated commercial
start of Phase III is also a risky approach because Manufacturing site. This includes all the associated
statistics show that there is still a relatively high knowledge, information and skills to be able to
attrition rate during Phase II due to both efficacy and manufacture the DS and DP at the receiving site.
clinical safety failures. However, one positive benefit Information will include that related to the Drug
of this approach is that it is usually easier for the Substance, the formulation, the pack or device used
company to demonstrate that Drug Product used in the manufacturing process and the associated critical
the pivotal Phase III clinical trials is equivalent to the quality parameters. TT also involves the
intended commercial product, assuming that any development and successful transfer of the analytical
changes during Phase III are minimal. and microbiological test methods and specifications
for the DS and DP that will become the final Quality
This should pave the way for a more straightforward Control; QC procedures used at the commercial
Pre Approval Inspection; PAI when it comes to Production site.
regulatory review of the Product Licence Application
(referred to as the Marketing Authorisation STEPS IN TECHNOLOGY TRANSFER
Application; MAA in Europe and the New Drug PROCESS: Technology Transfer is not a single way
Application; NDA in the USA and Japan). Most process. The development of new formulation goes
regulatory authorities, including the US Food and through many stages. During development of a
Drug Administration; FDA, the Medicines and formulation, it is important to understand procedure
Healthcare products Regulatory Agency; MHRA in of operations used, critical and noncritical
the UK and the European Agency for the Evaluation parameters of each operation, production
of Medicinal Products; EMEA, require three phases environment, equipment and excipient availability,
of clinical trials and sufficient data to show that the which should be taken into account during the early
new Drug Product can be licensed as safe, effective phases of development of formulation, so that
and of acceptable quality. successful scale up can be carried out.

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Appropriate care during technology transfer is for predetermined period of time 9. The processes are
important to enhance drug quality as developed by classified into the three categories:
R&D in final formulation as well as to assure quality

FIG. 4: ILLUSTRATES 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

Research phase, development phase and For drug substance the quality design is to determine
production phase. starting materials and their reaction paths and basic
specification of the drug.
1) Research phase (Development of technology
by R&D): 2) Development Phase:
a. Quality Design For drug products the quality a. Research for factory production: To
design corresponds to pharmaceuticals design to manufacture drugs with qualities as designed, it
design properties and functions such as- is required to establish appropriate quality
control method and manufacturing method, after
 Elimination of adverse reactions, detecting variability factors to secure stable
quality in the scale up (validation) that is
 Improvement of efficacy, performed to realize factory production of drug
 Assurance of stability during distribution and designed on the basis of result from small scale
experiments.
 Data based on various data such as chemical and
physical properties, efficacy, safety and stability b. Consistency between Quality and
obtained from preclinical studies. Specification:

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 When product specification is established on packaging, stability profile of packaging and

the basis of the quality of the product shelf life of packaging.
determined in the above, it is required to verify
that the specification adequately specifies the  Master formula: It describes formulation
product quality 12. order and manufacturing instructions.
Formulation order and Manufacturing
 Relations between upper and lower limits of Instructions gives idea of process order,
manufacturing formula (composition and environment conditions required and
manufacturing methods) and upper and lower manufacturing instructions for dosage form
of control limits of the product specification development.
should be fully understood, and the consistency
between the product quality and specifications  Specifications and standard test procedure;
should be maintained. STPs: It helps to know active ingredients and
excipients profile, in- process parameters and
 In short, the consistency between quality and specifications, product release specification
specification is to ensure in the products and finished product details.
specification that the quality predetermined in
the quality design is assured as the manufacture 3) Production Phase:
quality, and the product satisfies the quality of a. Validation & Production:
design.
 Production is implemented after various
c. Assurance of consistency through validation studies verify that it is able to stably
development and manufacturing: product based on transferred manufacturing
 For this purpose, the transferring party in formula.
charge of development should fully understand
 While the manufacturing facility accepting
what kind of technical information is required
technology is responsible for validation, the
by the transferred party in charge of
research and development department
manufacturing and should establish an
transferring technology should take
appropriate evaluation method to determine
responsibility for validation such as
whether a drug to be manufactured meets the
performance qualification; PQ, cleaning
quality of design.
validation, and process validation; PV unique
 For stable production of consistent products, it to subject drugs.
is fundamental to fully refer to information of SCALE UP FOR PRODUCTION: Scale up
similar products of the past maintained by the involves the transfer of technology during small
manufacturer when research for factory scale development of the product and processes. It is
production is implemented. essential to consider the production environment and
d. Technology Transfer from R&D to system during development of process10. Operators
Production: R&D provides technology transfer should concentrate on keeping these things in mind
dossier; TTD document to product development that their segment of the production process running
laboratory; PDL, which contains all information smoothly if technology transfer is implemented
of formulation and drug product as given below: thoughtfully. Effective technology transfer helps to
provide process efficiency and maintain product
 Master formula card; MFC: It includes quality.
product name along with its strength, generic
name, MFC number, page number, effective FEEDBACK FROM PRODUCTION AND
date, shelf life and market. TECHNOLOGY TRANSFER OF MARKETED
PRODUCT:
 Master packaging card: It gives information
about packaging type, material used for  To accumulate technical information obtained
from repeated production.

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 The information of modify various standards.  Forming alliances with partners with
marketing and distribution capability: The
 The improvement of process and products. developer of the technology may have fully
developed the technology and even have obtained
 The changes of specifications and methods. regulatory approvals and product registrations for
 The technical information of reviewed and the product to be sold but it lacks the marketing
updated at regular intervals. and distribution channels to give it a marking
capability and must collaborate with another
 Establish of adequate Feedback system. organization that does have that capability.

EXHIBIT BATCHES: After taking scale up  Lack of resources to launch product

batches of the product, manufacturing of exhibit commercially: The original inventor of
batches takes place. In case of exhibit, batch sizes are technology may only have the resources to
increased along with equipments and their processes. conduct early-stage research such as animal
This is done for filling purpose in regulatory studies and toxicology study, but doesn’t have
agencies. The Purpose behind to run three the resources to take technology through its
consecutive batches are to shows process clinical and regulatory phases.
consistency, reproducibility and to demonstrate that
the manufacturing process is under control  Exploitation in a different field of application:
throughout all the stages. The developer of the technology might be
capable of exploiting the technology itself in the
REASONS FOR TECHNOLOGY TRANSFER: field of diagnostic applications and may grant
There may be many reasons why a developer of the exploitation right to commercial partner for the
technology might consider making its technology exploitation of therapeutics applications. By
available to another person to exploit, instead of transferring the technology for the use in another
exploiting the technology itself. Some of this are13-14: field of application to another person, the
developer of the technology creates another
 Forming alliances with partners that can income stream from the exploitation that takes
progress the development to take it to market: place on that place in that other field.
The developer of the technology might have the
resources to take the technology to particular In the exploitation of pharmaceutical products
state of development, such as up to animal technology transfer by collaborating with this way to
studies and toxicology studies, but does not have bring a pharmaceutical product to market is common
the resources to take the technology through its feature of the industry.
regulatory phases and must collaborate with
another organization to take it through these IMPORTANCE OF TECHNOLOGY TRANS
phases and into the market. FER 20: The importance of technology transfer from
a development perspective is nothing new. More than
 Forming alliances with partners with three decades back, Mansfield (1975) pointed out
manufacturing capability: The developer of the that, “One of the fundamental processes that
technology may have taken the technology to a influence the economic performance of nations and
state of development so that it is near market firms is technology transfer. Economists have long
ready but does not have the clean room recognized that the transfer of technology is at the
manufacturing capability or resources to heart of the process of economic growth, and that the
manufacture the product and must partner with progress of both developed and developing countries
another organization that does have the depends on the extent and efficiency of such transfer
15
capability. The developer of technology may . In recent years economists have also come to
only have manufacturing equipment which is realize or rediscover the important effects of
suitable for small scale operation, and must international technology transfer on the size and
collaborate with another organization to do large patterns of world trade.” Technology transfer is an
scale manufacturing. area of interest not just to business, economists, and
technologists but also to other disciplines such as

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anthropology and sociology (Zhao and Reisman, This process is important for elucidation of necessary
1992). While anthropologists emphasize the impact information for technology Transfer from R&D to
of TT on changes in patterns of culture and society, Process Development Laboratory and for
sociologists are more concerned with its role as a development of existing products to the production
vehicle to develop the capacity of individuals and for commercialization.
societies to cope with modernisation and related
changes accompany it. It is helpful to develop dosage form in various ways
like it provides efficiency in process, help to
For economists, as argued by Mansfield (1975), the maintain quality of product, helps to achieve
focus is on economic growth and achievement of standardized process which in turn facilitates timely
economic goals. However, from the perspective of and cost effective production. If the technology
business and technologists the main focus of TT is to transfer is implemented thoughtfully then production
improve the competitive advantage of firms through process run smoothly, minimize the risks during
the enhancement of customer value (Ramanathan, production runs and a robust manufacturing process
2001). It is envisaged that, through the improvement for routine commercial manufacturing is achieved.
of competitive advantage, a firm and its partners
collaborating in the TT will gain financial and other FACTS ABOUT TECHNOLOGY TRANSFER
17
strategic benefits. :

Mayer and Blaas (2002) point out that, in recent  The technology transfer means actions to transfer
decades, small and medium enterprises; SMEs have information and technologies necessary to realize
begun to utilize technology transfer as a strategic quality of design of drugs during manufacturing.
means of meeting challenges posed by the
globalisation of business. Due to their small size and  Appropriate technology transfer is important to
skill resource constraints, they cannot carry out upgrade the quality of design to be the quality of
internal R&D to generate their own technologies but product, and ensure stable and high quality of the
still need a flow of new technology to be able to product.
compete. This need has created a new niche market  It should be noted that drugs may influence
for technology transfer (Morrissey & Almonacid human lives and health, and their raw materials,
2005). compositions and manufacturing methods are
The importance of technology transfer, from an changed during their long term manufacturing
economic and competitiveness perspective, has also and marketing.
stimulated university industry technology transfer.  To assure the drug quality, it is desired to make
This is evident from the emergence of technology sure 5 W’s and 1 H, that is what, when and why
transfer offices in most research industries and information should be transferred to where and
universities (Siegel et al. 2004). Ramanathan (2000) by whom and how to transfer, then share
shows that in today’s international business setting, knowledge and information of the drug product
depending on the attributes of the technology, its between transferring and transferred parties .
intended use, and the motivations of the transferee
and transferor, a wide range of TT modalities are  The technology transfer does not mean one time
available 16. actions taken by the transferring party toward the
transferred party, but means continuous
In pharmaceutical industry, Technology Transfer is
information exchange between the both parties to
the practice of transferring scientific findings from
maintain the product manufacturing 22.
one organization to another for further development
so that new products such as medicines, educational  Technology transfer can be considered successful
tools and health services can become available to the if a receiving unit can routinely reproduce the
public. It is the intersection between business and transferred product, process or method against a
science and it is both integral and critical to the drug predefined set of specifications as agreed with a
discovery and development process for new sending unit or a development unit.
medicinal product.

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TECHNOLOGY TRANSFER DOCUMEN-  Raw materials and components.

TATION 18-19: Technology transfer documentation
is generally interpreted as documents indicating  Synthetic route.
contents of technology transfer for transferring and
transferred parties. The raw data of the documents  Rational for dosage form & formula designs and
should be prepared and compiled accordingly and design of manufacturing methods.
should be always readily available and traceable.  Rational and change histories of important
For successful technology transfer, task assignment processes and control parameters.
and responsibilities should be clarified and
 Quality Profiles of manufacturing batches,
acceptance criteria for the completion of technology
including stability data.
transfer concerning individual technology to be
transferred. Quality assurance department should  Specifications and test methods of drug
established confirmation process for all kinds of substances, intermediates, drug products, raw
technology transfer documentation and should check materials, and components, and their rationale;
and approve the documentation. validity of specification range of important tests
such as contents impurities and dissolution,
A successful technology transfer document contains
rational for selection of test methods, reagents
both “know how” and “know why.” With antecedent
and, columns, and traceability of raw data of
and peripheral information, members of the
those information.
technology transfer team have more to work with,
can better evaluate options and can distinguish the Product specification file:
critical from the incidental. This document is to
provide all relevant information so that the transfer  Information necessary for the start and
goes easily and smoothly, future changes can be continuation of product manufacturing and
made in full understanding of why the process and necessary for quality assurance of the product;
product is in its current configuration, and the Development Report.
reasons for the selection of particular unit operations,
equipment, and conditions, can be clearly  Information necessary for assurance of operation
understood. safety.

Organization for Technology Transfer: One of the  Information necessary for environmental impact
most significant elements for successful technology assessment.
transfer is a closed communication between
transferring and transferred parties. Therefore,  Information of costs.
organization for technology transfer should be
 Other specific information of the product.
established and composed of both party members,
scope of responsibilities of each party should be Technology Transfer Plan:
clarified and feedback of information should be
ensured. It is desirable that this organization  Describe items and contents of technology to be
complies with GMP 21. transferred.
Research and Development Report: The research  Describe detailed procedures of individual
and development report; development report is a file transfer and transfer schedule.
of technical development and the research and
development department is in-charge of its  Establish judgment criteria for the completion of
documentation 23. It contains: the transfer.

 Historical data of pharmaceutical development of  The transferring party should prepare the plan
new drug substances and drug products at stages before the implementation of the transfer, and
from early development phase to final application reach an agreement on its contents with the
of approval. transferred party 24.

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Technology Transfer Report: organizes and directs work on his/her aspect of the
project, and supplies information to the team that is
 Report the data after technology transfer expected to impact other areas as shown in figure 5.
according to the technology plan. When the management decides to transfer a given
process from development to manufacturing, the
 Evaluation the data and the predetermined development project team should meet and establish
judgment criteria. the technology transfer team. The team is then
 Both transferring and transferred parties can trained on the technology transfer process, so that
document the technology transfer report; each member is thoroughly familiar with both the
however, they should reach an agreement on its business methodology to be used and the technical
contents. aspects of the process being transferred. The team
members must then be trained on the use of the
TECHNOLOGY TRANSFER TEAM 25: Science process tools, to help organize and assemble
technology and products are very rarely created in a numerical data, assign action items, determine the
vacuum, depending solely on internal expertise. The current level of readiness, and identify areas of
technology transfer team is a cross-functional team weakness or omission. At this point it is possible to
representing all departments, suppliers, and define and follow a reasonable course of action 26.
customers involved in the transfer. Each Successful technology commercialization depends on
representative provides information on his/her access to a skilled workforce in management,
functional area’s needs, works on action items, production, sales, distribution, and support.

FIG. 5: ILLUSTRATES THE RESPONSIBILITIES OF THE MEMBERS OF DIFFERENT DEPARTMENTS IN A

PHARMACEUTICAL COMPANY

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MISSION OF TECHNOLOGY TRANSFER  Construction of technology roadmaps in priority

TEAM: areas to define future trends to avoid the pitfalls
of buying out-dated, inappropriate technology
 The mission of technology transfer team is to and ensure non-obsolescence of technology.
develop and implement a methodology that
ensures the effective and efficient transfer of  Preparation of a detailed technology transfer
robust and well documented candidate agreement.
production processes from development to
manufacturing 27.  Preparation of a detailed technology transfer
implementation plan based on the decisions
 The ultimate goal for successful technology reached during negotiations.
transfer is to have documented evidence that the
manufacturing processes for drug substances and  Preparation of a scheme to assess the impact of a
drug product, respectively, are robust and technology transfer project from market,
effective in producing the drug substances and financial, technological and organizational
drug product complying with the registered perspectives.
specifications and good manufacturing practice
requirements. IMPLEMENTATION OF TECHNOLOGY
TRANSFER 31:
 Filing of the drug product in different regulatory
markets or countries for approval through an  Avoids the technology transfer only by handing
effective technology transfer. over the technology transfer documentation 29.

TRAINING BETWEEN DEVELOPMENT AND  Both parties should cooperate to implement

MANUFACTURING: Effective training of all technology education training and validation at
involved in the new process, from production facilities where the transferred technology is
operators to regulatory personnel involved in actually used.
preparing the license submission, is essential to VERIFICATION OF RESULT OF
project success. Training is required in both the TECHNOLOGY TRANSFER: After the
understanding of the technology transfer process and completion of technology transfer and before the
in the technical transfer. Training in the technology start of manufacturing of the product, the transferring
transfer process provides a structure for subsequent party should verify with appropriate methods such as
training in the process technology. Generally, product testing and audit that the product
training is initiated during validation activities manufactured after the technology transfer meets the
installation qualification; IQ, operational predetermined quality and should maintain records of
qualification; OQ, performance qualification; PQ and the results 30.
completed during production scale qualification;
PSQ. Following standard cGMP requirements, all FACTORS INFLUENCING TECHNOLOGY
training is documented, and involves identified TRANSFER:
members of all relevant departments 28.
(A) Drivers for Technology Transfer 31-32:
Under this technology transfer capacity-building
“training of trainers programme” participants will be  Good business and manufacturing practices:
imparted skills in the following areas: The Company’s success is primarily the result of
its adoption of good business and manufacturing
 Preparation of a business case, based on market practices, particularly in the areas of product
assessments, realistic forecast demands of the identification and formulation technology.
final product, and reasonably accurate operating
costs, to show how the proposed TT project can  Potential for competitive pricing: Balance cost
enhance competitiveness, profitability, and to remain competitive by having higher private
growth 32. sector prices and very low public sector prices.

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 Strategic planning: Create an enabling attention should be given to supporting access to

environment for vertical integration, with information. This has a number of dimensions,
prospects for higher capacity utilization and from better documentation of available resources,
eventual lowering of production costs. to the longer-term issue of addressing the
complexity of the global knowledge market. In
 Promising market scale and accessibility: the absence of effective systems for
While it is not easy to define the market size or disseminating market-relevant information,
type that will make for viable economic technology-holders may find it difficult to
production, it is generally the case that, the larger identify precisely who is interested in purchasing
the country or geographic bloc, the greater the their technology, while technology-demanders
market potential and investment appeal. face a similar challenge in finding entities willing
to transfer their technology.
 Adherence to regulatory standards: The
pharmaceutical industry is one of the most  Opportunities for contingency supply:
heavily regulated, to ensure quality, safety and Multinational pharmaceutical companies are
efficacy of its medicines and the well-being of inclined to transfer technology to local
patients. The ability to meet international manufacturers with the potential to receive when
regulatory standards, or at least those of the they foresee an inability to meet time scales and
major markets, is a precondition for many volume demand from large procurers.
technology transfer activities. Regulations and
standards apply also in low- and middle-income  Access to new machinery, training, know-how
countries. For example, governments require and business partnership: This makes the
product registration and data submissions to prospect of technology transfer very desirable to
demonstrate quality, safety and efficacy. local pharmaceutical manufacturers since the
technology, equipment, etc. could be applied
 Skilled workforce: Human capital is an essential profitably beyond the initial purpose.
element of the technology transfer process. The
successful absorption of technology or know- (B) Barriers of Technology Transfer 33-34:
how in the recipient country and its translation  Lack of awareness knowledge and efficiency:
into greater economic development hinges on the Automation of production processes to improve
availability in the host country of an educated efficiency and lower costs.
workforce with, for example, engineering and
management skills.  Lack of government focus low market share:
Local producers face significant challenges in
 Innovation- friendly environment with sound meeting International Quality Standards and
Intellectual Property Protection and capturing a critical market share. Greater market
Enforcement: To successfully attract imported share would increase profitability
technology and to build the necessary
preconditions for adapting imported technology,  Web access and scientific publication: Limited
countries need a supportive environment that access to scientific journals led to enormous
includes strong intellectual property protection problems for developing nations scientists.
and enforcement. Effective enforcement of any
 Cost of prequalification: There is benefit in
intellectual property laws and regulations already
meeting International Standards since it opens up
in force provides transparency and certainty for
the opportunity for trading across the entire
investors, licensees and customers. The level of
world.
intellectual property protection tends to be
directly and positively linked to the rate of  National security issues and restrictions on
technology transfer. exports of particular technology: International
controls designed to protect national security and
 Proper access to information or increased
to prevent the proliferation of important
information exchange: Where adequate
technologies also restrict the flow of
intellectual property systems are in place,
technologies.

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 Inadequate funding in important areas and  Alignment with Economic Development

possible treaties: There are areas of research of Priorities: The finite or limited resources
importance to the developing world that are available to governments imply that measures
being funded inadequately. taken to promote technology transfer need to
both be realistic and to fit with overall policy
 Labour issues: The pharmaceutical sector goals. A technology transfer policy dedicated to
demands relatively skilled labour. High labour the creation of completely new types of
turnover and absenteeism owing to unattractive economic activity and one which is as complex
conditions of service is negative contributor. and as highly regulated as the pharmaceutical
sector can present a much bigger challenge than
(C) Approaches to overcome barriers in
building on a sector that already exist.
technology transfer 35:
 Commercializing publicly funded  Co-operative research agreements: Global
technologies: The basic pattern envisioned is to support for public sector research might be
give institutions receiving public research funds encouraged is through co-operative research
the right to obtain and exploit patents on agreements designed to meet specific goals. It
inventions developed in the course of research. would seem more feasible to focus efforts on
technologies of significant social benefit to the
 Political stability and good transparent developing nations.
governance: A country’s relative political and
economic stability will influence the rate of  Possible treaty on scientific access: There has
inward technology transfer and can be seen as a also been a proposal for an international treaty on
pre-condition for any technology transfer. Even access to knowledge and technology negotiated
when research-based pharmaceutical company on the basis of the type of reciprocity found in
technology transfers are philanthropic in nature, normal international trade negotiations. The
they need to be sustainable in order to achieve concept is mean to be non- zero sums in the sense
their goals. Political leadership is critical to that, like free trade in goods, free trade in
address global and local health challenges and, scientific ideas benefits all and such
more importantly, healthcare system capacity arrangements could be made bilaterally as well as
strengthening. multilaterally.
 Research tool patents and freedom to operate SUCCESS OF TECHNOLOGY TRANSFER: The
for the public sector: Patents sometimes make it different “C” for successful technology transfer is:
difficult for public researchers to carry out their Communication, Certainty, Challenges, Capacity
research or to make the products of that research and Commitment 36.
available. It is intensified by the tendency of  Communication: The technology transfer chain
some publicly funded research laboratories to is often long, in terms of both distance and time.
avoid use of a patented technology without Effective communication is thus another essential
permission even in nations where no relevant ingredient in the recipe for successful technology
patent is in force. transfer. Efficient and effective two way
communication and corporation between key
 Appropriate Capital Markets: For many stakeholders will do much to remove barriers.
governments seeking to expand technological
capacity, attracting direct investment is very  Certainty: A lack of certainty, and the
important, but there is also a question of making consequential high levels of risk, both real and
the most of the spill over benefits of investment. perceived, are recognized a major impediments
This can reveal a need for adequate capital to the successful establishment and ongoing
markets. Governments can also promote inward operation of functional markets. Removing
investment through tax breaks and other forms of barriers to technology transfer often translates
incentives designed to encourage technology into increased certainty, and decreased risk, for
transfer, in compliance with international trade the key stakeholders such as developers,
rules. suppliers and recipients.

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 Challenges: There are many barriers to Licensing is an important phenomenon of technology

successful technology transfer. All along the transfer that has gained momentum in pharmaceutical
transfer path, from the supply side of technology industry by which pharmaceutical companies can
to demand side, impediments occur at very node contribute to research and development. Technology
and, due to restrictions on movement of transfer is a complex issue and should be deal with
information and materials, for every linkage in using holistic approach.
technology transfer chain.
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How to cite this article:

Dogra R, Garg R and Jatav P: Technology Transfer in Pharmaceutical Industry: Transfer of process from Development to
Commercialization. Int J Pharm Sci Res 2013; 4(5); 1692-1708.

International Journal of Pharmaceutical Sciences and Research 1708