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International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
232
Technology Transfer in Pharmaceutical Industries through
Product Development and Scale-Up Process Approaches:
Challenges and Opportunities for Developing Countries Biruk Abate
Faculty of Chemical and Food Engineering, Bahir Dar Institute of Technology, Bahir Dar University, Bahir Dar, P.O.Box 26,
Ethiopia
Article-This review article discloses the issue of
pharmaceutical technology transfer in developing countries
that has generated and debated for many years. Given
technology centrality to development, and technology
acquisition necessity by developing countries for further
development and benefit, it is desirable to generate, transfer
and diffuse the best available pharmaceutical technology in
these countries through product development and scale-up
techniques. Unfortunately, most of the world’s advanced
technology is generated privately by transnational
corporations, whose principal research and development
activity is located in developed countries, creates an
asymmetry between technology possession and technological
need location. There is a gap between the technology
developed and owned by firms in developed countries and
that can be obtained and utilized by developing countries. The
main objective of this review article is to disclose the working
procedure of product development and scale-up techniques
and keystone professions for technology transfer process in
pharmaceutical industries in developing countries through
taking an invention from its inception in a laboratory to a
commercialized drug product and to highlight how technology
is transferred, importance of technology transfer, reasons for
technology transfer, factors influencing technology transfer :
drivers and barriers, steps involved in technology transfer and
to identify policy approaches that might overcome those
barriers.
Keywords: Developing countries, pharmaceutical, product
development, scale-up, technology transfer
I. INTRODUCTION
Transfer of advanced technology is essential for
economic development as it is one means by which low-
and middle-income countries can accelerate the acquisition
of knowledge, experience and equipment related to
advanced, innovative industrial products and processes. It
has been credited with the potential to help improve health,
increase the reliability of supply and decrease reliance on
imports, raise the competence of the local workforce, and
reverse the “brain drain” from low and middle income
countries, by increasing local “high-tech” employment
opportunities [7].
Transfer of technology is the practice of transferring
scientific findings from one organization to another for
further development, so that new products and health
services can become available to the public [3].
Technology transfer is the intersection between business,
science, engineering, law and government and is both
integral and critical to the drug discovery and development
process for new medicinal product [17]. Here chemical
engineers produce bulk pharmaceutical compounds used in
safety assessment and clinical trials. They can handle
synthetic organic processes using complex organic
chemistry and advanced separation technology to recover
products. They can monitor and evaluate new
pharmaceutical processing technologies together working
in process research and developmental areas and their work
provides the foundation for the ultimate pharmaceuticals
manufacturing process.
I-A. Importance of technology transfer
The process is important to elucidate necessary
information for technology transfer from research &
development to product development laboratory and for
development of existing products to the production for
commercialization [14]. In the pharmaceutical industry
technology transfer refers processes that are necessary for
successful progress from drug discovery to product
development, to clinical trials to full scale
commercialization or it is the process by which a developer
of technology makes its technology available to
commercial` partner that will exploit technology[6,8]. In
pharmaceutical industry preparation of dosage form needs
scale up in/at several stages, such as small scale laboratory
development from 0.5-2 kg batch can be scaled up to 5-10
kg and then to20-100 kg on a pilot scale. Production scale
can typically range from 200 kg to greater than 1000 kg.
Technology transfer involves manufacturing drug product
with increasing batch sizes on larger equipment or using
continuous processing on pilot scale equipment.
International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
233
Generally scale up involves the transfer of technology
and the transfer of knowledge that has been accumulated
during the small scale development of product and
processes [12, 18, 19]. It is important to realize that good
communication is critical for formulation and process
transfer to be successful. It is essential for a researcher or
developer of technology to make available this technology
to another person’s to exploit for the progress of
development of technology and for exploitation of a
technology in different fields of applications and to make is
use with another organization that may have better
manufacturing capability, marketing capability and
commercial capability. In the pharmaceutical industry,
technology transfer by collaborating with other
departments and other organizations to commercialize a
pharmaceutical product is a common process [13, 16]. Over
and above the beneficial impact on economic and social
development normally credited to technology transfer, in
the field of pharmaceuticals, transferring technology can
help improve the health of recipient countries’ populations
by increasing access to innovative medicines and vaccines
[7, 13, 17].
IB- Reasons 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 resources to launch product commercially:
The original inventor of technology may only have the
resources to conduct early-stage research such as animal
studies and toxicology study, but doesn’t have the
resources to take technology through its clinical and
regulatory phases.
Due to lack of marketing and distribution capability: The
developer of technology may have fully developed the
technology and even have obtained regulatory approvals
and product registrations, but it may not have the marketing
and distribution channels.
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 [10, 13].
I-C. Technology transfer steps
It’s much more than simply handing over technology -
The transfer of R&D pharmaceuticals is more than a
question of “bricks and mortar” or providing a “tool box”.
It occurs through many channels, all of which result in
improving the economic capabilities of the recipient. What
is transferred may be a physical object or pure knowledge.
Following one definition, one can identify the following
elements:
“Techno-ware”: for the pharmaceutical industry this would
include the transfer of physical objects such as equipment
for use in research laboratories or production equipment for
manufacture of pharmaceuticals ingredients, or formulation
or packaging of final products.
“Human-ware”: skills and human aspects of technology
management and learning, such as a training course for
researchers or general practitioners across the world.
Technology transfer can also create positive spillover
effects into associated industries and into the supporting
public sector research infrastructure.
“Info-ware”: all techniques related to knowledge,
information and technology, in the form of a technology
license.
“Orga-ware”: organizational and procedural knowledge
needed to operate a given technology relating to a chemical
or biological compound. This tells us that technology
transfer is not a single way process. Whether a tablet, a
transdermal patch, a topical ointment, or an inject able, the
transformation of a pharmaceutical prototype into a
successful product requires the cooperation of many
individuals. The classic view of a flow from basic to
applied technology is a great over simplification-
sometimes, e.g. problems or insights arising at the
production level give rise to new ideas that contribute to
fundamental basic advance. At least in some sectors, close
links between the basic researchers and manufacturing
experts, and even marketing personnel contribute to
competitiveness and advancement [3, 11, 18]. Development
of new formulation goes through many stages as shown in
figure1. During development of a formulation, it is
important to understand procedure of operations used,
critical and non-critical 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 research & development in final
formulation as well as to assure quality for predetermined
period of time. The various steps involved in technology
transfer are given below (Figure1).
International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
234
It illustrates the technology transfer success criteria that
is sending and receiving unit of technology transfer is not a
“one way street”. The sending unit and receiving unit must
be equally involved in the process to ensure success [1, 8].
Figure 1. Schematic representation of technology transfer process [9,
15]
II. PHARMACEUTICAL TECHNOLOGY TRANSFER
II-A. Development of technology by research &
development during research phase
Design of procedure and selection of excipients by
research & development
Selection of materials and design of procedures is
developed by research & development on the basis of
innovator product characteristics. For this different tests
and compatibility studies are done.
Identification of specification and quality by research &
development
Generally it should be considered by research &
development that quality of product should meet the
specifications of an innovator product. For this different
stability studies are carried out for innovator product and
for product which is to be manufactured.
II-B. Technology transfer from research & development to
production during development phase
Research & development provides technology transfer
dossier document to product development laboratory,
which contains all information of formulation and drug
product as given below:
Master formula card
It includes product name along with its strength, generic
name, master formula card 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
It helps to know active ingredients and excipients
profile, in process parameters and specifications, product
release specification and finished product details.
II-C. Optimization and Production (Production Phase)
Validation studies
Production is implemented after validation studies that
can verify that process is able to stabilize the product based
on transferred manufacturing formula. While the
manufacturing department accepting technology is
responsible for validation, the research and development
department transferring technology should take
responsibility for validation such as performance
qualification, cleaning validation, and process validation
which are unique to subject drugs.
Scale up for production
Scale up involves the transfer of technology during the
small scale development of the product and processes. It is
essential to consider the production environment and
system during development of process. Different
operations: dispensing, sifting, blending, compaction/dry
granulation/wet granulation, compression, coating are used
in the formulation of solid dosage form. From blending to
film coating, each process is easy for pharmaceutical
professionals to be absorbed in the particular part of the
manufacturing process for which they are directly
responsible.
International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
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Operators concentrate on keeping their segment of the
production process running smoothly. But the whole
manufacturing line can be improved, even before
production begins, if technology transfer is implemented
thoughtfully. Effective technology transfer helps to provide
process efficiency and control and maintain product quality
[16, 18]. To avoid scale up problems, it is important for
chemists – with expert advice from chemical engineers -to
choose the correct conditions to scale [20]. For example
scale up of agitation can be based on a number of factors
but it is recommended to use constant power per unit
volume or mass [21]. This mixing energy dissipation is
given by:
Ei = NpN3d5/V, where
d = impeller diameter (m)
Np = power number
N = rotational speed (sec-1
)
V = volume (m3)
Specifications and standard test procedure
It helps to know active ingredients and excipients
profile, in process parameters and specifications, product
release specification and finished product details.
II-D. Technology transfer documentation
Technology transfer documentation is generally
interpreted as document indicating contents of technology
transfer for transferring and transferred parties. Each step
from research & development to production should be
documented, task assignments and responsibilities should
be clarified and acceptance criteria for completion of
technology transfer concerning individual technology to be
transferred. It is duty of quality assurance department to
check and approve the documentation for all processes of
technology transfer.
Development report
The ultimate goal for successful technology transfer is to
have documented evidences. The research & development
report is a file of technical development, and the research
and development department is in charge of its
documentation. This report is an important file to indicate
rationale for the quality design of drug substances and drug
specifications and test methods. The development reports
before the approval inspection. Although the development
report is not prerequisite for the application for approval, it
can be used at the preapproval an inspection as valid
document for quality design of new drug. In addition, this
report can be used as raw data in case of post-marketing
technology transfer.
The development report contains data of pharmaceutical
development of new drug substances and drug products at
stages from early development phase to final application of
approval, information of raw materials and components,
rational for dosage form & formula designs and design of
manufacturing methods, change in histories of important
processes and control parameters, stability profile,
specifications and test methods of drug substances,
intermediates, drug products, raw materials, and
components, which also includes validity of specification
range of important tests such as contents impurities and
dissolution, rational for selection of test methods, reagents
and, columns, and traceability of raw data of those
information.
Technology transfer plan
The technology transfer plan is to describe items and
contents of technology to be transferred and detailed
procedures of individual transfer and transfer schedule, and
to establish judgment criteria for the completion of the
transfer. The transferring party should prepare the plan
before the implementation of the transfer and reach an
agreement on its contents with the transferred party.
Report
Report completion of technology transfer is to be made
once data are taken accordingly to the technology plan and
are evaluated to confirm that the predetermined judgment
criteria are met. Both transferring and transferred parties
can document the technology transfer report however; they
should reach an agreement on its contents [3].
Exhibit
After taking scale up batches of the product,
manufacturing of exhibit batches take place. In case of
exhibit, batch sizes are increased along with equipments
and their processes involved. They are done for filing
purposes in different regulatory agencies [5].
II-E. Stages in the development of a new medicine and why
technology transfer
Continuous knowledge transfer and industry’s paradigm
shift:
Industry’s paradigm shift includes continuous transfer of
knowledge and technology, improved “lifecycle”
management, good business practice, speed to market,
globalization and advances the state-of-theart.
International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
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Continuous knowledge
Transfer- and Regulatory Stakeholder Opportunities
Regulatory stakeholder opportunities which should contain
highly interpretable regulations and guidelines, intermittent
transfer of knowledge, reactive inspection and review
practices as mentioned below.
Technology transfer- How and When
- Knowledge Transfer Process
- Technology Transfer Success Criteria
Figure 2. Product development flowchart, source: Handbook of pharmaceutical [6, 19]
International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
237
Figure 3. Product development flowchart continued from figure 2 [6, 19]
International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
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Figure 4. Continuous knowledge transfer and industry’s Figure 5. Continuous knowledge transfer and regulatory
stakeholder opportunities [8] paradigm shift [8]
Figure 6. Knowledge transfer process-how and when [8]
International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
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Figure 7. Knowledge Based Technology Transfer Process [10]
Figure 8. Effective technology transfer is critical to success in pharmaceutical industry [8]
International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
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Table II-A
Stages in the Development of a New Medicine and technology transfer [8]
Discovery
4-10 years
Exploratory Development
3+ years
Regulatory Development
3+ years
Commercialization
3+ years
Research target:
-Biological Evaluation
-Integrated Research
-Candidate Drug
-Formulation
-Patents
Formulation Development
&Process Development
Phase I-Clinical trials
Phase II-Clinical trials
Phase III-Clinical trials
* Build /Select API
Manufacturing
Manufacturing
Registration
* Built/Select
Manufacturing
Facilities
Launch
* Sales
Optimization using statistical methods for scale up:
When dosing solutions of reagents in the laboratory,
chemists usually add to the surface of the agitated liquid
and this works fine on small scale. If this is done on the
plant, however, poor mixing may occur in large reactors.
The key is to add the reagents into a region of high
turbulence, such as close to the tip of the agitator, using a
dip pipe, or to add reagents via a recirculation loop.
In many companies process optimization using one
parameter at a time variations is carrying out whereas the
trend elsewhere is to use the Design of Experiments (DoE)
approach, recognizing that variables are rarely independent
of each other for example rate of addition and temperature.
For these detailed parameter studies it is important to study
variables which affect scale up, such as dosing time and
mixing, and parameters in the work-up and product
isolation as well as in the reactions. Only by looking at the
effect of all these interacting parameters can a truly
optimized process, which works well on scale and is
efficient and robust, be developed [20].
For pharmaceutical processes, regulatory authorities are
keen to see the DoE approach used in new submissions,
since it shows that “quality has been is designed into the
process” and gives assurance that the process robust, and
that the manufacturer knows the design space in which to
operate and where the edge of failure lies. Such data is of
course important and extremely useful for a plant manager
operating any pharmaceutical or chemical process and
process understanding always leads to better process
control and usually to more successful scale-up![20].
II-G. Technology transfer team
The technology transfer team members and their
responsibilities are tabulated in Table II-B [2].
II-H. Factors influencing technology transfer
Drivers for technology transfer:
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.
Strong economy and environment: For technology transfer
to be successful there needs to be supportive business and
scientific environment in the recipient country, and that
environment should include skilled workers, economic and
political stability, supportive regulatory environment,
market size and potential and a well developed national
infrastructure of natural resources and transport.
Transparent and efficient regulation:
Pharmaceuticals are necessarily a high regulated
industry and the regulatory function must be efficient and
transparent for technology transfer to be economically
viable.
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.
International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
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Access to new machinery, training, knowhow 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.
Figure 9. The Drug Discovery and Development Process and Technology Transfer [22].
International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
242
Table II-B
Constitution of technology transfer team and their responsibilities
Technology Transfer Team Member Responsibilities
Process Technologist - Central focus for transfer activities.
- Collates documentation from donor site
- Performs initial assessment of transferred project for feasibility,
compatibility with site capabilities and establishes resource requirements.
Quality Assurance Representative - Reviews documentation to determine compliance with marketing
authorization.
- Reviews analytical methods with quality control to determine capability,
equipment training requirements.
- Initiates conversion of donor site documentation into local systems or
format.
- Initiates or confirms regulatory requirements, e.g., change to
manufacturing license, variations to market authorization if process
changes needed, etc.
Production Representative - Reviews process instructions (with process technologist) to confirm
capacity and capability.
- Considers any safety implications, e.g., solvents, toxic, sanitizing
materials.
- Considers impact on local standard operating procedures.
- Considers training requirements of supervisors or operators.
Engineering Representative - Reviews (with production representative) equipment requirement.
- Initiates required engineering modifications, change or part purchase.
- Reviews preventative maintenance and calibration impact, e.g., use of
more aggressive ingredients, more temperature sensitive process, and
modifies accordingly.
Quality Control Representative - Reviews analytical requirement.
- Availability with instruments.
- Responsible for analytical method transfer for drug substance and drug
product.
The Chemical Engineer’s Challenge in Pharmaceuticals
industries
As a profession, Chemical Engineers must now ensure
that they are involved with pharmaceutical product
development in the laboratory, so that they can use their
skills to ensure that the most efficient process is used to
manufacture pharmaceutical products. If they work
together with the other professionals in the industry they
have the opportunity to bring about the level of change that
came about within the oil and gas industry during the 1950s
and 1960s.
Since the health mankind and the industry’s impact on
the natural environment of the world will be to a great
extent dependent of their efforts to improve efficiency, it is
believed that the Chemical Engineers working within the
pharmaceutical industry are duty bound to set about
changing their own mind set and helping to change that of
others. If this opportunity is missed, it is unlikely that the
profession will have another opportunity to have such an
impact on the industry and the initiative will pass to a
different group of professionals.
It is unlikely than any other group will have the required
skill to reap all of the benefits to mankind that chemical
engineers can and we will all be the poorer for their failure.
Challenges or Barriers of Technology Transfer
Lack of efficiency Automation of production processes
to improve efficiency and lower costs. 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.
Cost of prequalification: There is benefit in meeting
International Standards since it opens up the opportunity
for trading across the entire world. Labour issues: The
pharmaceutical sector demands relatively skilled labour.
High labour turnover and absenteeism owing to
unattractive conditions of service is negative contributor [2,
9, 16].
International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
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The possible solutions or policy approaches to overcome
barriers in technology transfer and 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. 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. Web
access and scientific publication: Limited access to
scientific journals led to enormous problems for developing
nations scientists. 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.
Co-operative research agreements: Global support for
public sector research might be encouraged is through co-
operative 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 sum 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 [4,16].
Technology transfer isn’t done right
Process Validation may be unsuccessful. Delayed
regulatory approval and or product launch. Flawed
processing may result– high rate of batch rejections, costly
schedule revisions and excessive labour requirements.
Analytical methods cannot support production. Product
does not perform as intended.
Issues in the Technology Transfer Process
Pharmaceutical and biotech industry is becoming
increasingly competitive many players are boosting their
in-licensing activities, consolidating manufacturing
networks and outsourcing production to less costly third-
party manufacturers.
All these strategic initiatives require effective
technology transfer–smoothly moving technical knowledge
processes and analytical requirements between the different
parties involved. The issues to be focused are: Lack of
repeatable and scalable business processes– Many
organizations manage transfers as isolated, non strategic
events involving little more than a procedural exchange of
process documents between sending and receiving parties.
But without repeatable and scalable processes companies
are forced to reinvent the wheel each time technology
changes hands. This leads to variety of inefficiencies such
as suboptimal allocation of resources, higher development
costs, and quality and compliance issues.
Lack of experience working with Contract
Manufacturing Organizations–The key building blocks of
this approach include: rigorous selection process of
contract manufacturing partner, clear and well
documentation objectives and expectations, leading-edge
process guide-lines and project management tools and
high-performance, dedicated cross functional technology
transfer teams.
III. CONCLUSION
For many in the developing world, “technology transfer”
is seen simply in terms of developing local manufacturing
capacity. Manufacturing medicines is a complex, time-
consuming, capital intensive, highly regulated process
requiring an efficient supply chain and supporting
infrastructure of highly qualified staff, and reliable and
continuous supplies of water, gas and electricity.
According to some studies acknowledged challenges of
these types it is possible to say that a critical level of
industrial and socioeconomic development and human and
technical resources must be reached before any indigenous
industry can survive[7]. Transfer of technology in the
pharmaceutical industries is the way or action of
transferring information and technologies which are
necessary for realization of quality with designing of drugs
during manufacturing. A plan must be devised to organize
the personnel and the process steps and once prepared it
must be communicated to the involved parties in research,
at the corporate level and at the production site. Therefore,
the plan, persons involved, and the process should be
focused as primary considerations during an effective
technology transfer. The technology transfer does not mean
one-time actions taken by the transferring party toward the
transferred party, but means continuous information
exchange between both the parties to maintain the product
manufacturing [7].
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Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
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To 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
[5,7]. Appropriate transfer of technology is important to
upgrade the quality of design to be the quality of product,
and ensure stable and high quality of the product.
Technology transfer can be reflected successful if a
receiving unit can routinely reproduce the transferred
product, process or method against a predefined set of
specifications agreed with a sending unit and/or a
development unit. In general, progressive pharmaceutical
companies should give more attention to streamlining and
optimizing their technology transfer process to ensure the
rapid and successful introduction of new medicinal
products to market. A devoted technology transfer
organization should set up to facilitate and execute the
process. To achieve this end, it’s recommended that
company should adopt a rigorous process to select its
contract manufacturing partners to prevent issues in the
future collaboration process. Provide strong support for
scientific education and for basic research in areas that are
important to the nation. It is important to remove barriers to
the free flow of science and technology. Heading global
technological integration is far better for a world than
political restrictions on the transfer of technology.
IV. RESEARCH HIGHLIGHTS
Scale-up of pharmaceutical processes, particularly those
involving batch or semi-batch manufacture is well-known
to be a problematic area of chemistry and chemical
engineering, and can be costly when it goes wrong. By
correctly choosing and designing the synthetic route to a
fine drug substance, as well as controlling the reaction and
work up/product isolation parameters, many of the
difficulties in scale up can be avoided. The more complex a
process is in terms of chemistry and unit operations, the
more there is to go wrong. Therefore this review study
highlights what chemists and engineers can do in advance,
both in the laboratory and kilo laboratory, to prevent or at
least minimize scale up issues in pharmaceutical industries.
Therefore, pharmaceutical technology transfer can help
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. Pharmaceutical technology transfer
has important in extended benefits of R&D to the society
especially in developing countries in preparation of dosage
form needs scale up at several stages.
Developing countries are experiencing unprecedented
levels of economic growth and development, transfer and
use of pharmaceutical technologies which are promising
ways towards for production of high quality and low priced
drug product even though it costs high investment during
lab scale, scaling up and the beginning of the batch size
manufacturing processes. Technology transfer is the useful
process and needed for successful progress from drug
discovery to product development to clinical trials to full
scale commercialization. So the present research will
provide a milestone for the further research of
pharmaceutical technology transfer which actively
manipulated by the continual upside down efforts of
chemists and chemical engineers in their pilot plants as
well as in the pharmaceuticals processing units both in
primary or Active Pharmaceutical Ingredients synthesis
(APIs) and secondary processing stages.
V. LIMITATIONS
There may be a variation in this review results due to
type of technology selection and justification, the planning
stage, negotiation and technology transfer implementation
can influence the interpretation results of pharmaceuticals
technology transfer. In addition to these missing of scale-up
and product development techniques may enhance
pharmaceuticals technology transfer problems due to miss
assigning of professionals instead of focusing on chemists
and chemical engineers skill and knowledge input in
process development and scale up operations.It is unlikely
than any other group will have the required skill to reap all
of the benefits to mankind that chemical engineers can and
we will all be the poorer for their failure.
VI. RECOMMENDATIONS
During the development of a formulation, it is necessary
to understand the procedure of operations used ,critical and
non-critical parameters of each operation, production
environment, equipment and excipients availability should
be taken into account during the early phases of
development of formulation so that successful scale up can
be easily carried out.
Technology transfer cannot succeed on onetime action
by the transferring party toward the transferred party, but it
needs continuous information exchange between the both
parties to maintain the product manufacturing and to
achieve a successful and effective technology transfer
through organized plan, skilled persons involved and the
process.
International Journal of Emerging Technology and Advanced Engineering
Website: www.ijetae.com (ISSN 2250-2459, ISO 9001:2008 Certified Journal, Volume 6, Issue 7, July 2016)
245
Regarding to funding and policy aspects as far as my
knowledge is concerned it has to be facilitated or arranged
viz government private/ has to work jointly for any funding
issue of the scenario.
Author’s Contribution
The reviewed work is carried out by Biruk Abate (the
author). This research article was collected, organized and
reviewed from previous research articles and
pharmaceutical technology transfer guide books.
Acknowledgement
The author is very grateful to Dr. Merkuz Abera,
associate professor at Bahir Dar University College of
Agriculture and Environmental Science and Mr. Admassu
Fanta, Lecturer and Researcher at Bahir Dar Institute of
Technology Faculty of Chemical and Food Engineering,
Bahir Dar University for their giving me moral and
directing my attention to research and development in
addition to lecturing and advising activities in our
University.
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