Technology Transfer in Pharmaceutical Industries through Product ...

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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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.



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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).



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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.



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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.



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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]



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Figure 3. Product development flowchart continued from figure 2 [6, 19]



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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]



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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]



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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.



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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].



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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].



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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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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.



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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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