An Overview On Technology Transfer of Pharmaceutical Industry
An Overview On Technology Transfer of Pharmaceutical Industry
An Overview On Technology Transfer of Pharmaceutical Industry
net/publication/338987459
CITATIONS READS
3 7,059
7 authors, including:
Muthukumar Subramanaian
KMCH College of Pharmacy
22 PUBLICATIONS 10 CITATIONS
SEE PROFILE
Some of the authors of this publication are also working on these related projects:
STUDIES ON ORODISPERSIBLE FORMULATIONS FOR THE MANAGEMENT OF HYPERTENSION DURING PREGNANCY View project
All content following this page was uploaded by Muthukumar Subramanaian on 02 February 2020.
Received on 11 May 2019; received in revised form, 18 August 2019; accepted, 02 September 2019; published 01 February 2020
what it means it must be able to be transferred 1.3 Methods for Technology Transfer: Licensing
from one person to another. is the most common method of technology transfer.
There are two strategies for licensing one is
Third, it must have purpose-orientation, so licensing in and licensing out. In licensing - in
that it can be utilized for useful purposes in strategy, small companies and lack facilities to do
industry, farming, and commercial fields 6. basic research and these facilities want to buy other
research. In case of licensing - out strategy, the
There are two sorts of technology transfer
company right is given to another party 1.
processes 7:
1.4 Facets of Technology Transfer: The
Vertical
technology transfer could happen any of these
Horizontal
following ways:
Vertical technology transfer refers to the transfer of
Government labs to the private sector
data from basic study to development and
production respectively. Horizontal technology Between the private sector firms of the same
transfer refers to the movement and application of country
technology is to be used in one place or context to a From academia to private sector firms
different place. Commercial technology transfer is Academia, government, and industry
mutually agreed, and goal destined. The collaborations 1.
achievement of any specific technology transfer
1.4.1 Government Labs to Private Sector: This
depends upon method understanding or the
type of technology transfer is advantageous as the
flexibility to predict exactly the long term
government labs can get good financial support and
performance of a process 1.
funds from the govt. for their research work, and
Designing drug product Developing drug the technology developed by them reaches the
product Technology transfer private sector.
manufacturing site
1.4.2 Between the Private Sector Firms of the
1.1 Goals of Technology Transfer: It is to transfer Same Country: This type of technology transfer
product and process knowledge between and generally occurs due to lack of appropriate
manufacturing and within or between financial resources or inadequate knowledge of
manufacturing sites to achieve product realization. regulatory requirements thus, the private sector that
This knowledge forms the basis for the develops the technology is paid by another sector
manufacturing process, control strategy process that absorbs the technology
validation approach and ongoing continual
1.4.3 From Academia to Private Sector:
improvement 9.
Academic sectors that are actively involved in
1.2 Objective of Technology Transfer: research develop the technology and make it
available to private firms. By collaboration of
To explain the processing information to private firms with the institutions, money can be
transfer technology from R&D to production saved.
site by listing out information gathered during
R&D. 1.4.4 Between Academy, Private and
Government Sectors: In this type of technology
To explain the processing information to transfer government provides necessary funds to
transfer technology of already existing drug the academic institutions in developing technology
product between various places. that can be transferred to the industry.
needs scale up at several stages, such as pilot-scale Lack of Marketing Distribution and
from 0.5 - 2 kg batch can be scaled up to 5/10 kgs Distribution Capability: The developer of
then to 20/100 kg. Production scale typically ranges the technology could have absolutely
from 200 kg to 1000 kg. It involves manufacturing developed technology and even have obtained
of drug product with increasing their batch sizes regulative approvals and product registration,
with the help of larger equipment. Generally scale- but it may not have the marketing and
up involves transfer of technology and transfer of distribution channels and should collaborate
knowledge that has been accumulated during small within another organization that has the
scale development of product and process. Usually capability.
research has been carried out on a small scale
before it produced for large scale commercial 1.8 Factors that Affect the Process if Technology
batch. Technology transfer is important for Transfer in the Pharmaceutical Industry:
research activities to materialize on a large scale for Investment in R&D.
commercialization especially in case of developing
a drug product 13. Establishing the link between production and
research.
1.6 Flow Chart of Technology Transfer in the
Data development within the field of
Pharmaceutical Industry:
technology transfer methods.
Technology developer Organizational, equipmental and informational
infrastructures.
Technology receiving site
Awareness of basic and necessary factor need
for technology transfer.
Feasibility study
Consideration of existing and old technologies
16
.
Scale-up
2. Steps Involved in Technology Transfer:
Exhibit batches Transformation of Pharmaceutical prototype into a
successful product needs the cooperation of many
people. During development of a formulation, it is
Stability study
vital to understand procedure of operations used,
critical and non-critical parameters of every
Process validation batches operation, production environment,
instrumentation, and excipient convenience, that
Production batches ought to be taken into consideration throughout the
first phases of development of formulation, so that
1.7 Reason for Technology Transfer 15: successful scale-up can be carried out 17.
Lack of Manufacturing Capacity: the
developer of the technology could solely have Various Steps Concerned in Technology
to produce instrumentation that appropriates Transfer as Follows: 16, 17, 18
for lab and small scale operations and should 2.1 Research Phase (Development of Technology
partner with another organization to try to do by R&D):
massive scale manufacturing.
a) Design and Choice of Excipients by R&D:
Lack of Resources to Launch Product choice of materials and design of procedures
Commercially: The original inventor of are carried out by R&D on the premise of
technology may only have resources to innovator product characteristics. For this
conduct early stages research and phase - I completely different tests and compatibility,
and II clinical trials. studies are performed.
b) Identification of Specifications and Quality this stability, studies are carried out for
by R&D: Quality of product ought to meet innovator product and for product that is to be
the specifications of an innovator product. For manufactured.
2.2 Technology Transfer from R & D to 2.3 Optimization and Production (Production
Production (Development Phase): Phase):
R&D provides technology transfer dossier (TTD) a) Validation Studies: Validation studies verify
document to a product development laboratory that that the method will stabilize the product
contains all data of formulation and drug product as based on transferred manufacturing formula
given below: and production is enforced once validation
studies. The manufacturing department is
a) Master Formula Card (MFC): It includes accepting technology and liable for validation.
product name along with its strength, The research and development department
transferring technology ought to take
b) The generic name, MFC number, page
responsibility for validation like performance
number, effective date, shelf life, and market.
qualification, cleaning and method validation.
c) Master Packaging Card: It provides data
b) Scale Up for Production: Scale up involves
regarding packaging sort, the material used
the transfer of technology throughout small
for packaging, stability profile of packaging
scale development of the product and
and shelf life of packaging.
processes. It’s essential to contemplate the
d) Master Formula: It describes formulation production surroundings and system
order and manufacturing instructions. throughout the development of the method.
Formulation order and Manufacturing Operators ought to target keeping in mind that
Instructions offer the plan of process order, the production process can run smoothly if
surroundings conditions needed and technology transfer is enforced thoughtfully.
manufacturing instructions for the Effective technology transfer helps to provide
development of dosage form. process efficiency and maintain product
quality.
e) Specifications and Standard Test
Procedures (STPs): These help to know 3. Technology Transfer Team: As the team
active ingredients and excipients profile, in- concept is always the best approach to achieve
process parameters and specifications, product successful technology transfer projects. The core
release specifications and finished product technology transfer team must be commissioned
details. immediately following the decisions of the
executive management to pursue the drug candidate business 19. The technology transfer team consists
to commercialization. A typical technology transfer of the following members, and their responsibilities
core team will likely be comprised of individual’s are given below: 20
representatives of the different segments of the
TABLE 1: TECHNOLOGY TRANSFER TEAM MEMBERS AND THEIR RESPONSIBILITIES
TECHNOLOGY transfer RESPONSIBILITIES
team members
Process Technologist a) Central focus for transfer activities.
b) Collates documentation from the donor site
c) Performs initial assessment of the transferred project for Feasibleness, Compatibility
with site capabilities and Establishes resource needs.
QA Representative d) Reviews documentation to work out compliance with marketing authorization (MA)
e) Reviews analytical strategies with QC to work out capability, instrumentation
training requirements.
f) Initiates conversion of donor site documentation into local systems or format.
g) Initiates or confirms regulatory needs, e.g., an amendment to manufacturing license;
variations to MA if method changes needed, etc.
Production Representative h) Reviews process instructions (with process technologist) to verify capacity and
capability.
i) Considers any safety implications, e.g., solvents; toxic; sanitizing materials.
j) Considers the impact on local standard operating procedures (SOPs).
k) Considers the training requirements of supervisors or operators.
Engineering Representative l) Reviews (with production representative) instrumentation requirement.
m) Initiates required engineering modifications, change or part purchase.
n) Reviews preventative maintenance and calibration impact, e.g., use of a lot of
aggressive ingredients; more temperature-sensitive method, and modifies
consequently.
QC Representative o) Reviews analytical requirement.
p) Availability with instruments.
q) Responsible for analytical technique transfer for drug substance and drug product.
Rational for selection of test methods, of data and technologies necessary to realize
reagents and columns Verification of results. quality of design of drugs throughout
manufacturing. The technology transfer does not
b) Technology Transfer Plan: The technology mean one-time actions taken by the transferring
transfer plan describes the things and contents of party toward the transferred party however, suggest
technology to be transferred and elaborate that continuous information exchange between both
procedures of individual transfer and transfer the parties to maintain the product manufacturing.
schedule, and to determine judgment criteria for the Technology transfer is a complex issue and should
completion of the transfer. The transferring party be deal with using holistic approach.
ought to prepare the plan before the
implementation of the transfer and reach an ACKNOWLEDGEMENT: I acknowledge the
agreement on its contents with the transferred support of KMCH College of Pharmacy, Tamil
party. Nadu DR. MGR. Medical University.
14. Kaur A, Sharma OP and Dhari J: Technology transfer in 20. Anuj A and Bhuvnesh KS: A review on the importance of
pharmaceutical industry. International Journal of Current technology transfer in pharmaceutical industry. An
Pharmaceutical Research 2013; 5(1): 17-18. International Journal of Pharmaceutical Research 2016;
15. Biswajit D and Rao N: Transfer of technology for 1(4): 141-42.
successful integration into the global economy. a case 21. Biruk A and Biruk Abate: Technology transfer in
study of the pharmaceutical industry in India. UNCTAD pharmaceutical industries through product development
2002. and scale-up approaches: challenges and opportunities for
16. Singh A and Aggarwal G: Technology transfer in the developing countries. International Journal of Emerging
pharmaceutical industry: a discussion. IJPBS 2009; 1-3. Technology and Advanced Engin 2016; 6(7): 232-43.
17. http://www.amuasi-paper-edited.pdf. 22. Autio E and Laamanen T: Measurement and evaluation of
18. Sagar P, Akshay K, Pankaj P, Mayur G and Shivram J: technology transfer: review of technology transfer
Review article on technology transfer. International mechanisms and indicators. International Journal of
Journal of pure and applied Bioscience 2014; 2(3): 145-53. Technology Management 1995; 10(7/8): 643-64.
19. Souder WE, Nashar AS and Padmanathan V: A guide to 23. Technology Atlas Team: Components of technology for
the best technology transfer practices. Journal of resources transformation. Technological Forecasting and
Technology Transfer 1990; 15: 1-2. Social Change 1987; 32: 19-35.
This article can be downloaded to Android OS based mobile. Scan QR Code using Code/Bar Scanner from your mobile. (Scanners are available on Google
Playstore)