Information of Technology Transfer plan and exhibit

1. Technology transfer plan &
exhibit
Presented by- Akshay Prakash Nehe
Final year B pharmacy, AVCOP Sangamner
Sem -7 Roll no. 52

2. Technology transfer
Technology transfer is very common
in pharmaceutical manufacturing
but is often taken for granted,
which can led to production
problems and increased costs. This
presentation describes various
steps for performing a successful
technology transfer

3. Transfer of technology
TOT- A logical procedure that controls the transfer of
an established process together with its
documentation of professional expertise to site
capable of reproducing the process and its support
functions to a predetermined level of performance
Ref no. 2

4. Flowchart of technology transfer in pharmaceutical
industry
Technology
developer
Technology receiving site
Feasibility studies
Scale-up
Exhibit batches
Stability studies
Process validation batches
Production batches
Ref no. 5

5. Technology transfer plan
• The TT plan is to describe items & contents of technology to be
transferred, and detailed procedures of individual transfer &
transfer schedule establish judgment criteria for the completion of
the transfer.
• The transferring party should prepare the plan before the
implementation of the transfer & reach an agreement on its
contents with the transferred party
• The Report- Both transferring & transferred parties should
document the TT report
• The exhibit- After taking scale-up batches of product,
manufacturing of exhibit batches takes place. In case of exhibit
bathes sizes are increased along with equipment & their processes
• This is done for filing purpose in regulatory agencies
Ref no. 6

6. Tech transfer documentation steps
Tech transfer
chapter/
proposal
Tech transfer
package
Gap
analysis/ Risk
assessment
Tech transfer
plan
• 1st
documentatio
n step
• Purpose- to
provide a
general
framework for
a tech transfer
& details its
scope
• Should include
description of
teams,
stakeholders,
changes
• Tech transfer’s
success
criteria
The tech
transfer
package should
contain as
much
information as
necessary to
ensure that the
receiving unit
can
successfully
complete the
tech transfer
on time and
within budget
Implementing
a risk
assessment
strategy and
mitigating
those risks will
bring a
robustness to
the transfer
process &
ultimately
prepare it for
validation
Detail execution
of every
important steps
& various
activities

7. Need of technology transfer
• The developer should not be financially sound to require
discovered drug to the whole development because it includes
various steps. In such cases, the collaboration of the developer with
a corporation is needed so the invention could reach to the
market.
• If demand rises for the product then with collaboration within
developer & producing units to induce reciprocally benefitted.
- Points with respect to actual technology or process developer.
Importance of Technology Transfer
• It leads to the economic expansion of pharmaceutical industry influencing
the economic performance of the nation
• It leads to collaboration of science and business which may result in the
introduction of a new drug or health tool to the market
• It is critical process which results in transferring the scientific findings of
the research labs to be available to the commercial units
Ref no. 3

8. Technology Transfer Team
QA
personnel’s
Engineering
personnel
Production
personnel
QC
personnel
QA
personnel
Researchers
• Controlling
temp, pressure
of particular
area
• Calibration
status of
machines &
equipment
Key persons
To make a bridge between
research technologist &
manufacturing unit
• Cross verify instructions
provided by QA personnel’s
• Confirm capacity &
capability of manufacturing
unit
• Setting up testing procedures &
testing specifications
• Validating methods with QA
personnel
• Check & update equipment status
• Quality testing of formulation, post
manufacturing
Perform final review
including
• Equipment
qualification
• Testing
procedures
• Conducting
validation
• Stability studies
• Release of
formulation to
commercializati
on
Getting ready general info
regarding formulation within
kind of written format -
Dossier
Ref no. 4

9. Technology Transfer protocol
• The TT protocol should list the intended sequential stages of the transfer.
The protocol should include;
• Objective;
• Scope;
• Key personnel & their responsibilities;
• A parallel comparison of materials methods & equipment;
• The transfer stages with documented evidence that each critical stage has
been satisfactorily accomplished before the next commences;
• Identification of critical control points;
• Experimental design & acceptance criteria for analytical methods
• Info on trial production batches, qualification batches & process
validation;
• Change control for any process deviation encountered;
• Assessment of end product;
• Arrangements for keeping retention samples of active ingredients,
intermediates and finished products & info on ref substances where
applicable.
• Conclusion, including signed-off approval by project manager.
Ref no. 2

10. Planned transfer activities
• Pilot batches
i. To perform functionality characterization of the active ingredient & critical
excipients
ii. Manufacturing of small pilot batches to confirm feasibility of product using
API & excipients that receiving unit should using.
• Stability batch
i. Based on recommendation of technical report, company manufacture
stability batch to issue manufacturing/packaging protocol, batch reports as
well as stability protocol
ii. Evaluate & confirm critical process parameters & implement in-process
testing controls during stability batch
• Scale up
i. Scale up refers to rise within batch size of the product
ii. Product generated at this stage to access qualification & determine whether
a new tooling or packaging configuration is required or not
• Other studies
i. Perform a process validation, cleaning validation/validation, bulk holding
time, and packaging validation studies
• A report generated by this studies is needed for filing to restrictive agencies.
Ref no. 1

11. Examples side-by-side process comparison
Sending unit Receiving unit
• Pre-blend
Screen excipient A & B through a #12
mesh screen using a Sweco screener.
Blend both for 5 minutes in a 10-cubic-
foot V-blender.
• Blending
Screen excipients C & D and API through
a #12 mesh screen using a Sweco
screener. Add Excipients C, D, and pre-
blend between two equal parts of API.
Mix for 10 minutes in a 60-cubic-foot V-
blender with intensifier bar operating
• Compression
Compress tablets on a Korsch XL400
tablet press at 42-50 rpm (88,200-
105)tablets per hour. Tablet core is a 3/8-
inch round, flat, beveled tablet with a
“C” logo embossed on one side and
“250” on the reverse
• Pre-blend
Order of addition, hand versus
automated mixing and screening,
screen size, type and size of
equipment, mixing time
• Blending
For each blending step: order of
addition, ingredient quantities,
screen size, mixing time, mixing
speed.
• Compression
Model and make of tablet press,
compression, speed range,
description of logo on both sides.
Ref no. 1

12. Example of initial risk management
Item Level of change Risk Risk mitigation
Active ingredients Major Will use different
supplier of directly
compressible active
ingredients
granulation
Tested lots from three
suppliers for chemical
& physical properties.
Will conduct pilot
plant studies.
Excipients Minor Will use the same
suppliers
Sources were already
qualified at receiving
site.
Composition/formulat
ion
Minor Change to % of
lubricant used within
SUPAC limits
Will monitor sticking
issues during pilot
plant.
Batch size Minor RS will run a similar
batch size to that of
the sending site
within EWV
Will perform blend-
time studies on pilot
& scale up batches.
Major equipment Moderate Moving from a high
shear blender to a V-
blender
Will perform-/-
batches to confirm
the uniformity of final
blend

13. Item Level of change Risk Risk mitigate
In-process controls Minor Will maintain same
or more stringent in-
process controls
Will confirm in-
process controls in
pilot and scale-up
studies.
Analytical test
methods – Raw
materials and
finished products
None No changes planned
or will use USP
methods
Will verify all the
compendial methods.
Will transfer finished
products.
Finished product
specifications
None No changes planned Will use the same
release specifications
Stability
Primary packaging
components
None
Moderate
No changes planned
Planning to change
the bottle supplier.
Will use the same
type of resin but
from different
supplier
Will use the same
stability
specifications
Will perform
accelerated & long-
term stability studies
on pilot study
batches
Ref no, 1

14. TT agencies in India
• Asian & Pacific center for transfer of technology (APCTT)
• National Research Development corporation (NRDC)
• Technology information, Forecasting and assessment Council
(TIFAC)
• Biotech Consortium India Limited (BCIL)
• Technology Bureau for Small Enterprises(TBSE)
• Small Industries Development Bank of India (SIDBI)
Ref no. 2

15. Success of technology transfer “C”
Communication
Efficient & effective communication
Certainty
Successful TT includes increased
certainty & decreased risks
Challenges
Overcome them to establish well TT
with risk assessments
Capacity
Enhancing that TT that supports the
sustainable development thus
strengthening capacity for TT
Commitment
Good commitment to
overcome challenges
Ref no. 3

16. Barriers of technology transfer
The basic challenges faces by the organization while
transferring the technology can broadly be defined as
• Economic factors
Poor business administration, lack of business agreement,
lack of pre risk management
• Technical factors
The difference in the infrastructure of research lab and
manufacturing unit leads to technical issues
• Miscellaneous factors
Inadequate funding in imp areas like research centers leads to
incompetent results
• Labour issues
In pharma sector highly skilled and experienced persons are
required , lack in their no. may results in low production
Ref no. 4

17. Successful TT example
• Eli Lily has entered in technology transfer agreement with Shasun
chemicals & Drugs for the manufacturing of Anti TB drug CYCLOSERINE
produced by Shasun to meet Eli Lily global demand
Conclusion
• A tech transfer plan is a living document that captures all activities &
changes & risk involved in a technology transfer, A valuable tool that a
project manager or a technical lead maintains from the project inception
up to the completion of all activities
• TT can be considered successful if a receiving unit can routinely reproduce
the transferred product, process or method against a predefined set of
specifications.
• Technology transfer provides an opportunity to reduce cost on drug
discovery & development thus major pharmaceutical companies look for
technology transfer opportunity as it reduces risk, cost , & rate of failure
Ref no. 6

18. Reference
1. Technology transfer, by Anthony grenier, Copyright @CSE publishing
March 2019 Tablet & capsules
2. Study material by Dr. N. Patra BP 702 T. Industrial pharmacy II
3. Technology transfer in pharmaceutical industry; transfer of process from
development to commercialization : IJPSR (2013), vol. 4, issue 5 review article
by Rahul dogra, Rajeev garg & Prakash jadhav
4. TT: An overview process, review article by K. Pandey, H. Joshi.., published
@IJCPR in 2018
5. Technology transfer; case studies from real world, @PDA Israel, by Ofer
Dublinsky in March 2019
6. Technology transfer in pharmaceutical industry by K. Amneet, Sharma o. p
R&D dept in morepen labs @IJCPR in 2013

19. Thank you
Development
Product