The document presents a seminar on technology transfer (TT) in the pharmaceutical industry, highlighting its significance in moving from drug discovery to commercialization. It outlines the definitions, importance, and various components of TT, including the phases involved and documentation required for successful implementation. Key factors such as government collaboration, market viability, and policies that govern TT practices are also discussed to emphasize its critical role in maintaining drug quality and reducing development costs.

1. LOGO Seminar on
“Technology Transfer
portfolio in Pharmaceutical
Industry”
‘‘Technology is best when it brings people together’’
Presentation By:
Mr. Akshay S. Jirage
Formulation Development

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Contents
Documentation Involved in TT
Anatomy component of TT
What is Technology transfer (TT)
Facets involved in TT
Importance of Technology transfer
Policy and factor of TT
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Goals and steps involved in TT
References
In pharma industry Technology Transfer abbreviated as ‘TT’

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What is Technology Transfer
❖In the pharmaceutical industry, “Technology Transfer” refers
to the processes that are needed for successful progress from
drug discovery to product development to clinical trials to full-
scale commercialization.
• Vertical Technology transfer (from R&D to full scale commercialization)
• Horizontal Technology transfer (From one commercial site to another commercial site)
❖ It enable to upgrade drug quality planned during research
development and to final product during manufacturing as well
as to guarantee that stable quality is transferred.
❖ According to WHO, Transfer of technology is defined as “a
logical procedure that controls the transfer of any process
together with its documentation and professional expertise
between development and manufacture or between manufacture
sites”.
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Diagrammatic presentation
Production/commercial scale
Pilot scale
Scale up batch
Small scale laboratory
development
Batch size 200-1000kg*
Batch size 20-100kg
Batch size 5-10kg
Batch Size 05-2 kg
* Batch size may vary in commercial scale depend on availed capacity of equipment,
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Cycle Diagram represents ‘TT’
Feasibility
study
Production
R&D
lab
Stability
studies
Validation
batches
Technology
transfer
Scheme of product
commercialization
Scale Up
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Importance of Technology Transfer
As ‘TT’ has numerous importance in pharma sector for which
elaborate purpose are as follows:
❖ To elucidate necessary information to transfer technology
from R&D to actual manufacturing
❖ It provides an opportunity to reduce cost on drug discovery
and development
❖ For smooth manufacturing of commercialized product.
❖ Maintain quality of product and to achieve standardized
process.
❖ Documented evidence of the manufacturing process for drug
substance and drug products
❖ It provides an opportunity to reduce cost on drug discovery
and development
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Facets for ‘TT’
❖ Premises involved in TT:
• Government lab to private sector firm
• Between private sector firm of same country
• Between private sector firm of different country
• From academia to private sector firm
• Academia, government and industry collaboration
❖ facets for TT:
• Lack of manufacturing capacity
• Lack of resources to launch product commercially
• Lack of marketing and distribution capability
• Exploitation in a different field of application
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Policies involved in ‘TT’
❖ Policies:
• Experience in the business sector. It has to
demonstrate a reputable experience
• Cultural compatibility:It should belong to the same
geographic region
• Confidentiality: It should be guaranteed by signing a
secret agreement.
• Relations: with other institutions subcontracted in turn.
Application of the same rules as in the main contract.
• Financial solvency. Accreditation by a company
specialized in this kind of audits.
• The compliance with the regulatory requirements is
assured.
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Factors involved in ‘TT’
Development
priorities
Factors
Technology Transfer
Viable market
Political stability
Economy
Regulations
Skilled workers
EnforcementIPR
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Goals involved in ‘TT’
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Goals:
❖To take all the gathered knowledge and use it as the basis for
the manufacturing control strategy, the approach to process
qualification and on-going continuous improvement.
❖
❖The transition of the product/process/analytical method
knowledge between development and manufacturing sites.
❖To ensure variability of process and parameters are controlled
and sufficient in the face of the rigors of a commercial production
environment.
❖To verify parameters established during development are still
within the determined design space and adjusted at scale-up.

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Factors Affecting on ‘TT’
Development
priorities
Factors
Technology Transfer
Viable market
Political stability
Economy
Regulations
Skilled workers
Development
prioritiesIPR
There are list of factors affects technology transfer. From
which potential are as below.
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Steps involved in ‘TT’
Development
Phase
Production
Phase
Research
Phase
▪Selection of
Excipients
▪Process Design
▪Pre-formulation
▪Improvement of
Efficacy
▪Product stability
It involves transfer
of product from
R&D to product
development
laboratory (PDL)
▪In this phase
Technology
Transfer Dossier
(TTD) handed over
to PDL
It involves
▪Validation
studies
▪Scale up
Parameters
•Flexibility
•Cost
•Dependability
•Innovation and
product quality
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Anatomy component of ‘TT’
Technology
Transfer
B
E
C
D
A
‘Techno-ware’
▪Equipment
▪Physical objects
‘Human-ware’
▪Skilled personnel
▪Trainers
‘Info-ware’
▪Knowledge
▪Information
technology
Market
mechanism
▪Foreign direct
investment (FDI)
‘Orga-ware’
▪Knowledge of
organizational procedure
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Documentation involved in ‘TT’
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It involves data from initial development phase to successful
commercialization with critical aspects of manufacturing.
❖Research and development reports:
▪Detailed developmental outcomes from trails
▪Dosage form and formula design
▪Rationale for design of manufacturing methods
▪Rational and change histories of important processes and control
parameters
▪Quality profiles of manufacturing batches (including stability
data)
▪Specifications and test methods of drug substances,
❖Product Specification File (PSF):
▪Quality assurance of the product
▪Assurance of operation safety
Cont..

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Documentation involved in ‘TT’
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▪Environmental impact assessment
▪Information of costs
▪Other specific information of the product
❖Technology Transfer Plan:
▪Procedure of TT
▪Transfer Schedule
▪Establishment and judgment criterion
❖Technology Transfer Report (TTR):
▪Action points
▪Evaluation of technology plan
❖Approval by Quality Assurance Department
▪Confirm the process of technology transfer
Cont..

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Documentation involved in ‘TT’
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❖Technology Transfer Dossier (TTD):
Site designee shall receive TTD from R&D it include following parameters
of dossier:
▪Molecule information
▪Proposes Markets
▪Master Formula Card
▪Master Packaging Card
▪Critical process parameters
▪Shipping requirements
▪Standard test procedures for Raw materials/packing
materials/in-process/Finished product specifications.
▪Finished Product Specifications
▪Special Sampling requirements if any
▪Stability testing requirement
▪Product Development Report.

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Conclusion
 Action to transfer
of information and
technologies for
product realization.
 Bridge between
‘Donor side’ (R&D
or knowledge
center) and
‘Receptor side’
(drug mfg. site).
Technology
Transfer
‘3P” evaluated
in ‘TT’ are:
Plan
Process
Personnel
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References
1. Technology transfer in Pharmaceutical Industry: A review by Bharat
Bhusan et al. / Int. J. Pharm. Med. Res. 2014; 2(3): 94-99
2. Pharmaceutical technology transfer: an overview Alam and Ahmad,
IJPSR, 2013; Vol. 4(7): 2441-2449
3. Technology transfer in pharmaceutical industry- A Review Popat B.
Mohite and Sachin V. Sangle / International Journal of Advances in
Pharmaceutics 2017; 06(01): 01-07.
4. Rahul D Et.al. Technology transfer in pharmaceutical industry transfer
of process from development to commercialization. Int J pharm sci
res. 2013;4(5):1695
5. 2. Guidance for industry pharmaceutical quality system ICH Q10. FDA,
CDER, CBER. 2009;:08
6. Manish SM, Bharat P, Yakub S, Technology Transfer in Pharmaceutical
Industry; Facts and Steps Involved, American Journal of Pharmatech
Research, 2012; 2(4):78.
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19. LOGO