Terminologies used in

Technology Transfer
 Acceptance criteria - Measurable terms
under which test results will be considered
acceptable.

 Bracketing - An experimental design to

test only the extremes of, for example,
dosage strength. The design assumes that
the extremes will be representative of all
the samples between the extremes.
 Change control (C/C)

A formal system by which qualified

representatives of appropriate disciplines
review proposed or actual changes that
might affect a validated status. The intent
is to determine the need for action that
would ensure that the system is
maintained in a validated state.
 Corrective action (C/A) - Any action to be
taken when the results of monitoring at a
critical control point indicate a loss of
control. Critical Having the potential to
impact product quality or performance in a
significant way.
 Critical control point (CCP) - A step at
which control can be applied and is
essential to prevent or eliminate a
pharmaceutical quality hazard or reduce it
to an acceptable level.
 Design space - The multidimensional
combination and interaction of input variables
(e.g. material attributes) and process
parameters that have been demonstrated to
provide assurance of quality.
 Drug master file (DMF) - Detailed
information concerning a specific facility,
process or product submitted to the drug
regulatory authority, intended for the
incorporation into the application for
marketing authorization.
 Gap analysis - Identification of critical
elements of a process which are available at
the SU but are missing from the RU.
 Process validation - Documented
evidence which provides a high degree of
assurance that a specific process will
consistently result in a product that meets
its predetermined specifications and
quality characteristics.
 Quality risk management
 Two primary principles of quality risk
management are:
1) The evaluation of the risk to quality should be
based on scientific knowledge and ultimately link
to the protection of the patient.
2) The level of effort, formality and documentation
of the quality risk management process should
be commensurate with the level of risk.
 Quality risk management is a systematic process
for the assessment, control, communication and
review of risks to the quality of the drug
(medicinal) product across the product lifecycle.
 Quality risk management activities are
usually, but not always, undertaken by
interdisciplinary teams. When teams are
formed, they should include experts from the
appropriate areas (e.g., quality unit, business
development, engineering, regulatory affairs,
production operations, sales and marketing,
legal, statistics and clinical) in addition to
individuals who are knowledgeable about the
quality risk management process.

Responsibilities
 Initiating a Quality Risk Management

Process Quality risk management should

include systematic processes designed to
coordinate, facilitate and improve science-
based decision making with respect to
risk.
Possible steps used to initiate and plan a
quality risk management process might
include the following :
 Define the problem and/or risk question,
including pertinent assumptions
identifying the potential for risk;
 Assemble background information and/ or
data on the potential hazard, harm or
human health impact relevant to the risk
assessment;
 Identify a leader and necessary
resources;
 Specify a timeline, deliverables and
appropriate level of decision making for
the risk management process.
 Risk Assessment Risk assessment consists
of the identification of hazards and the
analysis and evaluation of risks associated
with exposure to those hazards.
 Quality risk assessments begin with a
well-defined problem description or risk
question.
 Three fundamental questions are often
helpful:
 What might go wrong?
 What is the likelihood (probability) it will
go wrong?
 What are the consequences (severity)?
  Risk Identification
 It is a systematic use of information to
identify hazards referring to the risk
question or problem description.
 Information can include historical data,
theoretical analysis, informed opinions,
and the concerns of stakeholders.
 Risk identification addresses the “What
might go wrong?” question, including
identifying the possible consequences
  Risk analysis

 Risk analysis is the estimation of the risk

associated with the identified hazards. It
is the qualitative or quantitative process
of linking the likelihood of occurrence and
severity of harms.
  Risk Evaluation
 It compares the identified and analyzed
risk against given risk criteria.
 The output of a risk assessment is either
a quantitative estimate of risk or a
qualitative description of a range of risk.
When risk is expressed quantitatively, a
numerical probability is used.
 Alternatively, risk can be expressed using
qualitative descriptors, such as “high”,
“medium”, or “low”, which should be
defined in as much detail as possible.
  Risk Control
 Risk control includes decision making to
reduce and/or accept risks. The purpose
of risk control is to reduce the risk to an
acceptable level. Risk control might focus
on the following questions:
 Is the risk above an acceptable level?
 What can be done to reduce or eliminate
risks?
 What is the appropriate balance among
benefits, risks and resources?
 Are new risks introduced as a result of the
identified risks being controlled?
  Risk Reduction
 Risk reduction focuses on processes for
mitigation or avoidance of quality risk
when it exceeds a specified (acceptable)
level.
 Risk reduction might include actions taken
to mitigate the severity and probability of
harm. Processes that improve the
detectability of hazards and quality risks
might also be used as part of a risk
control strategy.
  Risk communication
 Risk communication is the sharing of
information about risk and risk
management between the decision
makers and others.
 Parties can communicate at any stage of
the risk management process.
 The output/result of the quality risk
management process should be
appropriately communicated and
documented.
 Risk review A mechanism to review or
monitor events should be implemented.
The output/results of the risk
management process should be reviewed
to take into account new knowledge and
experience.
 The frequency of any review should be
based upon the level of risk.
 Risk review might include reconsideration
of risk acceptance decisions.
  Risk management methodology
 Quality risk management supports a scientific
and practical approach to decision-making. It
provides documented, transparent and
reproducible methods to accomplish steps of
the quality risk management process based
on current knowledge about assessing the
probability, severity and sometimes
detectability of the risk. The pharmaceutical
industry and regulators can access and
manage risk using recognized risk
management tools and/or internal
procedures (e.g., standard operating
procedures). Below is a non-exhaustive list of
some of these tools.
 Basic risk management facilitation
methods (flowcharts, check sheets etc.);
 Failure Mode Effects Analysis (FMEA);
 Failure Mode, Effects and Criticality
Analysis (FMECA);
 Fault Tree Analysis (FTA);
 Hazard Analysis and Critical Control Points
(HACCP);
 Hazard Operability Analysis (HAZOP);
 Preliminary Hazard Analysis (PHA);
 Risk ranking and filtering;
 Supporting statistical tools.
 (Process, Packaging and Cleaning)
 It should be established at the outset
whether the intention is to perform single-
batch manufacture, continuous production or
campaigns, and whether the RU can
accommodate the intended production
capacity.
 Consideration should be given to the level
and depth of detail to be transferred to
support production and any further
development or process optimization at the
RU as intended under the transfer project
plan.

Transfer from R & D to production

 The SU and the RU should jointly develop
a protocol for the transfer of relevant
information related to the manufacturing
process under consideration from the SU
to the RU, as well as the development of
an equivalent process at the RU.
 Process
 The SU should provide a detailed
characterization of the product, including its
qualitative and quantitative composition,
physical description, method of manufacture,
in-process controls and specifications,
packaging components and configurations,
and any special safety and handling
considerations.
 The SU should provide any information on
the history of process development which
may be required to enable the RU to perform
any further development and/or process
optimization intended after successful
transfer.
Such information may include the
following:
 information on clinical development, e.g.
information on the rationale for the
synthesis, route and form selection,
technology selection, equipment, clinical
tests, and product composition;
 information on scale-up activities: process
optimization, statistical optimization of critical
process parameters, pilot report and/or
information on pilot-scale development
activities indicating the number and
disposition of batches manufactured; and
 information or report on full-scale
development activities, indicating the
number and disposition of batches
manufactured, and deviation and change
control reports which led to the current
manufacturing.
 The SU should provide to the RU
information on any health, safety and
environmental issues associated with the
manufacturing processes to be
transferred, and resulting implications,
e.g. need for gowning or protective
clothing.
 The SU should provide to the RU information
on current processing and testing, including
but not limited to:
 a detailed description of facility requirements
and equipment ;
 process technology selection;
 information on starting materials, applicable
MSDs and storage requirements for raw
materials and finished products;
 description of manufacturing steps (narrative
and process maps or flow charts), including
qualification of in-processing hold times and
conditions, order and method of raw material
addition and bulk transfers between
processing steps;
 description of analytical methods;
 in-process controls, including, e.g.
identification of critical performance aspects
for specific dosage forms, identification of
process control points, product quality
attributes and qualification of critical
processing parameter ranges, statistical
process control (SPC) charts;
 validation information, e.g. validation plans
and reports, and annual product reviews;
 stability information; and an authorized set of
SOPs and work instructions for
manufacturing.
 It should follow the same procedural patterns
as those of the production transfer.
 Information on packaging to be
transferred from the SU to the RU include
specifications for a suitable container/closure
system, as well as any relevant additional
information on design, packing, processing or
labeling requirements needed for qualification
of packaging components at the RU.
 For quality control testing of packaging
components, specifications should be
provided for drawings, artwork, and material
(glass, card, fibre board, etc.).

Packaging
 Based on the information provided, the
RU should perform a suitability study for
initial qualification of the packaging
components.
 Packaging is considered suitable if it
provides adequate protection (preventing
degradation of the drug due to
environmental influences), safety
(absence of undesirable substances
released into the product), compatibility
(absence of interaction possibly affecting
drug quality) and performance
(functionality in terms of drug delivery).
 During the manufacturing process, pharmaceutical
products and APIs can be contaminated by other
pharmaceutical products or APIs if processing different
products.
 To minimize the risk of contamination and cross-
contamination, operator exposure and environmental
effects, adequate cleaning procedures are essential.
 The SU should provide information on cleaning procedures
in use at the SU to minimize crosscontamination due to
residues from previous manufacturing steps, operator
exposure and environmental impact, including: solubility
information of active ingredients, excipients and vehicles.

Cleaning
 The principal regulatory bodies entrusted with the
responsibility of ensuring the approval, production
and marketing of quality drugs in India at reasonable
prices are:
 The Central Drug Standards and Control
Organization (CDSCO), located under the aegis of
the Ministry of Health and Family Welfare.
 The CDSCO prescribes standards and measures for
ensuring the safety, efficacy and quality of drugs,
cosmetics, diagnostics and devices in the country.
Regulates the market authorization of new drugs and
clinical trials standards; supervises drug imports and
approves licences to manufacture the above-
mentioned products.

Approved regulatory bodies

and agencies
 The Drugs Controller General of India
(DCGI), With respect to licensing and quality
control issues, market authorization is
regulated by the Central Drug Controller,
Ministry of Health and Family Welfare,
Department of Biotechnology, Ministry of
Science and Technology (DST) and
Department of Environment, Ministry of
Environment and Forests. State drug
controllers have the authority to issue
licences for the manufacture of approved
drugs and monitor quality control, along with
the Central Drug Standards Control
Organization (CDSCO).
 The Food and Drug Administration (FDA
or USFDA)

 is a federal agency of the United States

Department of Health and Human Services,
one of the United States federal executive
departments.
 The FDA is responsible for protecting and
promoting public health through the Control
and supervision of food safety, tobacco
products, dietary supplements, prescription
and over the counter pharmaceutical drugs
(medications), vaccines, biopharmaceuticals,
blood transfusions, medical, electromagnetic
radiation emitting devices (ERED), cosmetics,
animal foods & feed and veterinary products.
 The Therapeutic Goods
Administration (TGA) is part of the
Australian Government Department of
Health, and is responsible for regulating
therapeutic goods including prescription
medicines, vaccines, sunscreens, vitamins
and minerals, medical devices, blood and
blood products. Almost any product for
which therapeutic claims are made must
be entered in the Australian Register of
Therapeutic Goods (ARTG) before it can
be supplied in Australia.
 Medicines and Healthcare products
Regulatory Agency (MHRA) regulates
medicines, medical devices and blood
components for transfusion in the UK.
 TT agencies in India

 APCTT, NRDC, TIFAC, BCIL, TBSE /SIDBI

 It is a United Nations Regional Institution under the
Economic and Social Commission for Asia and the
Pacific (ESCAP) established in 1977 in Bangalore,
India.
 In 1993, the Centre moved to New Delhi, India.
APCTT promotes transfer of technology to and from
small- and medium-scale enterprises (SMEs) in Asia
and the Pacific.
 APCTT implements development projects funded by
international donors aimed at strengthening the
environment for technology transfer among SMEs.
The objective of APCTT is to strengthen the
technology transfer capabilities in the region and to
facilitate import/export of environmentally sound
technologies to/from the member countries.

Asian and Pacific Centre for

Transfer of Technology (APCTT)
 National Research Development Corporation
(NRDC) was established in 1953 by the
Government of India, with the primary
objective to promote, develop and
commercialize the technologies / know-how /
inventions / patents / processes emanating
from various national R&D institutions /
Universities and is presently working under
the administrative control of the Dept. of
Scientific & Industrial Research, Ministry of
Science & Technology.

National Research Development

Corporation (NRDC)
 TIFAC is an autonomous organization set up
in 1988 under the Department of Science &
Technology to look ahead in technology
domain, assess the technology trajectories,
and support innovation by networked actions
in selected areas of national importance
TIFAC embarked upon the major task of
formulating a Technology Vision for the
country in various emerging technology
areas.

Technology information,
Forecasting and
Assessment Council (TIFAC)
 New Delhi was incorporated as public limited
company in 1990 under The Companies Act, 1956.
The consortium is promoted by the Department of
Biotechnology, Government of India and financed by
the All India Financial Institutions and some corporate
sectors BCIL 's major functions include the
development and transfer of technology for the
commercialization of biotechnology products, project
consultancy, biosafety awareness and human
resource development BCIL has been successfully
managing several Flagship schemes and Programes of
the Department of Biotechnology, Government of
India. Most notable include Biotechnology Industry
Partnership Programmed.

Biotech Consortium India Limited

(BCIL) Biotech Consortium India
Limited (BCIL)
 Often collaborative research efforts with outside
institutions are defined in Memoranda of
Understanding (MOU) before other agreements are
executed.
 An MOU typically defines how intellectual property will
be shared and the roles and responsibilities of the
involved parties. If you are planning to enter into a
collaborative relationship with an outside party, it is
important to discuss the possibility of an MOU.
 Office of Technology Commercialization is responsible
for drafting MOUs related to collaborative research.
MOUs typically identify a lead institution for managing
intellectual property and provide details on how
licensing income will be shared.

Memoranda of Understanding
(MOUs)
Granularity of TT Process
(API, excipients, finished
products, packaging
materials)
 The specifications of the starting materials
(APIs and excipients) to be used at the RU
should be consistent with reference
batches (development batches,
biobatches or batches manufactured at
the SU).
 Any properties which are likely to
influence the process or product should be
identified and characterized.

Starting materials
 The SU should provide the drug master
file (DMF) and any relevant additional
information on the API to the RU to be
checked against the specifications of the
API.
 The following information should be
provided:

Active Pharmaceutical
Ingredients (API)
 manufacturer;
 flow chart of synthetic pathway, outlining
the process, including entry points for raw
materials, critical steps, process controls
and intermediates;
 definitive form of the API (including
photomicrographs and other relevant
data) and any polymorphic and solvate
forms;
 solubility profile;
 partition coefficient (including the method
of determination);
 intrinsic dissolution rate (including the
method of determination);
 particle size and distribution (including the
method of determination);
 bulk physical properties, including data on
bulk and tap density, surface area and
porosity as appropriate;
 water content and determination of
hygroscopicity, including water activity
data and special handling requirements;
 microbiological considerations (including
sterility, bacterial endotoxins and
bioburden levels where the API supports
microbiological growth) in accordance
with regional pharmacopoeial
requirements;
 specifications and justification for release
and end-of-life limits;
 summary of stability studies conducted in
conformity with current guidelines,
including conclusions and
recommendations on retest date;
 listing of potential and observed synthetic
impurities, with data to support proposed
specifications and typically observed levels;
 information on degradants, with a listing of
potential and observed degradation products and
data to support proposed specifications and
typically observed levels;
 potency factor, indicating observed purity and
justification for any recommended adjustment to
the input quantity of API for product
manufacturing, providing example calculations;
and
 special considerations with implications for
storage and/or handling, e.g. safety and
environmental factors and sensitivity to heat,
light or moisture.
 The excipients to be used have a potential
impact on the final product. Their
specifications as well as the DMF should,
therefore, be made available by the SU
for transfer to the RU site.
 The following information should be
provided for all types of excipients:

Excipients
 description of functionality, with justification
for inclusion of any antioxidant, preservative
or any excipient above recommended
guidelines;
 manufacturer;
 specifications, i.e. monographs and additional
information that may affect product
processing or quality for compendia
excipients, or a complete listing of
specifications, including analytical methods
and justification for release limits for non-
compendial excipients.
 For excipients used for the first time in a
human drug product or by a new route of
administration, the same level of detail as for
a drug substance should be provided;
 special considerations with implications for
storage and/or handling, including but not
limited to safety and environmental factors
(e.g. as specified in material safety data
sheets) and sensitivity to heat, light or
moisture solubility; and
 regulatory considerations, i.e. compendial
status and appropriate regulatory information
for non-compendial excipients; information
on residual solvents or organic volatile
impurities; and documentation to support
compliance with transmissible animal
spongiform encephalopathy certification
requirements (where applicable).
 Depending on the type of dosage form, the
SU should provide relevant information on
physical properties of excipients to the RU,
including:
 definitive form (for solid and inhaled dosage
forms);
 solubility profile (for solid, inhaled and
transdermal dosage forms);
 partition coefficient, including the method of
determination (for transdermal dosage
forms);

Finished Products
 intrinsic dissolution rate, including the
method of determination (for transdermal
dosage forms);
 particle size and distribution, including the
method of determination (for solid, inhaled
and transdermal dosage forms);
 bulk physical properties, including data on
bulk and tap density, surface area and
porosity as appropriate (for solid and inhaled
dosage forms);
 compaction properties (for solid dosage
forms);
 melting point range (for semi-solid/topical
dosage forms);
 pH range (for parenteral, semi-solid/topical,
liquid and transdermal dosage forms);
 ionic strength (for parenteral dosage forms);
 specific density/gravity (for parenteral, semi-
solid/topical, liquid and transdermal dosage
forms);
 viscosity and/or viscoelasticity (for parenteral,
semi-solid/topical, liquid and transdermal dosage
forms);
 osmolarity (for parenteral dosage forms);
 water content and determination of
hygroscopicity, including water activity data and
special handling requirements (for solid and
inhaled dosage forms); moisture content range
(for parenteral, semi-solid/topical, liquid and
transdermal dosage forms
 microbiological considerations in
accordance with regional pharmacopoeial
requirements (for parenteral, semi-
solid/topical, liquid, inhaled and
transdermal dosage forms); and
 information on adhesives supporting
compliance with peel, sheer and adhesion
design criteria (for transdermal dosage
forms).
 Information on packaging to be transferred
from the SU to the RU include specifications
for a suitable container/closure system, as
well as any relevant additional information on
design, packing, processing or labeling
requirements needed for qualification of
packaging components at the RU. For quality
control testing of packaging components,
specifications should be provided for
drawings, artwork, material.

Packaging
 Documentation

The documents used

in technology transfer
?
 Project definition
 Quality agreement Facility
assessment
 Health & Safety assessment
 Skill set analysis and training
 Analytical me
 Starting material Evaluation
Equipment selection and transfer
transfer
 Process transfer: manufacturing and
packaging
 Cleaning
 The SU should provide information to the RU on the
layout, construction and finish of all buildings and
services (heating, ventilation and air-conditioning
(HVAC), temperature, relative humidity, water, power,
compressed air) impacting the product, process or
method to be transferred.
 The SU should provide information on relevant health,
safety and environmental issues, including:
 inherent risks of the manufacturing processes (e.g.
reactive chemical hazards, exposure limits, fire and
explosion risks).
 health and safety requirements to minimize operator
exposure (e.g. atmospheric containment of
pharmaceutical dust).
Premises and Equipment
Premises
 buildings and services at the RU should be
capable of accommodating the product,
process or method under transfer to the
agreed quality standard and production
volume in compliance with GMP;
 DQ, design qualification;
 IQ, installation qualification;
 OQ, operational qualification;
 API, active pharmaceutical ingredient;
 SOPs, standard operating procedures; RU,
receiving unit.
 quality control laboratories should be
equipped and capable of testing all APIs,
excipients, intermediate and finished
products, packaging components and
cleaning validation samples
 buildings intended for production of a highly
sensitizing nature (e.g. penicillins and
cytotoxic materials) should be dedicated for
this purpose and located in a different facility
from other production units; and
 health, safety and environmental issues,
including waste management, emergency
planning, minimization of operator exposure
and environmental impact, should be
addressed at the RU in compliance with any
regulatory or company-developed rules,
regulations and limits.
 Equipment
 The SU should provide a list of equipment,
makes and models involved in the
manufacture, filling, packing and/or control
of the product, process or method to be
transferred, together with existing
qualification and validation documentation.
Relevant documentation may include:
• drawings;
• manuals;
• maintenance logs;
• calibration logs; and
• SOPs (e.g. equipment set up, operation,
cleaning, maintenance, calibration, storage).
 GMP requirements should be satisfied,
and intended production volumes and
batch sizes (e.g. same, scaled-up or
campaign) should be considered. Factors
to be compared include:
• minimum and maximum capacity;
• material of construction;
• critical operating parameters;
• critical equipment components (e.g.
filters, screens, temperature/pressure
sensors); and
• range of intended use.
 The facility- and building-specific location of
all equipment at the RU should be considered
at the time of drawing up process maps or
flow charts of the manufacturing process to
be transferred, including movement of
personnel and material.
 The impact of manufacturing new products
on products currently manufactured with the
same equipment should be determined.
Where existing producing equipment needs
to be adapted to be capable of reproducing
the process being transferred, a detailed
development project should be included in
the transfer protocol.
 Qualification and validation of facilities,
equipment, systems and procedures are
essential to demonstrate that all critical stages of
the transfer project have been completed
successfully, enabling the RU to reproduce the
product, process or method routinely to the
specifications agreed with the SU.
 Validation performed as part of the transfer
project should be documented in a validation
master plan (VMP).
 The VMP should identify the stages which need to
be validated and define acceptance criteria.

Qualification and Validation

 Quality Control: Transfer of analytical methods should
accommodate all the analytical testing required to
demonstrate compliance of the product to be transferred
with the registered specification.
 Transfer of analytical methods used to test pharmaceutical
products, their ingredients and cleaning (residue) samples,
needs to be in place before process validation studies of
manufacturing operations can be carried out.
 The SU should prepare a protocol defining the steps to be
undertaken for analytical method transfer.
 The analytical methods transfer protocol should describe
the objective; scope; responsibilities of the SU and the RU;
materials, methods and equipment; the experimental
design and acceptance criteria; documentation (including
information to be supplied with the results, and report
forms to be used if any); deviations; references; signed
approval; and details of reference samples (APIs,
intermediates and finished products).
 provide method-specific training for analysts and
other quality control staff;
 provide acceptance criteria and validation protocols
for any RU training exercises;
 assist in analysis of quality control testing results;
 define and justify all methods to be transferred for
testing a given product, ingredient or cleaning
sample;
 define experimental design, sampling methods and
acceptance criteria;
 provide any validation reports for methods under
transfer, and demonstrate their robustness;
 provide data for the equipment used and any
standard reference samples; and
 provide approved SOPs used in testing.

The SU's responsibilities for the

transfer of analytical methods
 review analytical methods provided by the SU,
and formally agree on acceptance criteria before
execution of the transfer protocol;
 ensure that the necessary equipment for quality
control is available and qualified at the RU site.
Equipment should be replicated where possible,
but it is accepted that different models, e.g.
spectrometers and chromatographs, could
already be in place;
 ensure that adequately trained and experienced
personnel is in place for analytical testing;
 provide a documentation system capable of
recording receipt and testing of samples.

The RU's responsibilities

 SU and RU analysts assay two retained samples
from SU;
 SU and RU analysts then assay two sub-potent
samples (available from SU or spiked);
 SU and RU analysts assay samples taken from
RU production;
 RU analyst provides sufficient replicate analyses
to enable a significance test (e.g. student’s t)
against the established method at the SU site;
and
 a similar exercise should be undertaken for
analysis of low levels of APIs.
 All training activities and outcomes should be
documented.
A suggested analytical training
protocol would be
 The analytical methods transfer protocol should cover
the following sections:
 objective;
 scope;
 responsibilities of the SU and the RU;
 materials, methods and equipment;
 the experimental design and acceptance criteria;
 documentation (including information to be supplied
with the results, and report forms to be used if any);
 deviations;
 references;
 signed approval; and
 details of reference samples (APIs, intermediates and
finished products). Successful transfer and validation
of analytical methods should be documented in a
report.

Analytical methods Transfer

Commercialization - practical
aspects and problems (case
studies) Technology transfer
are discussed with certain
practical studies.
 Case Study 1 The blending of drug with excipients is
presented in table 2. [3] Factors considered in the
proposed technology transfer (scale up)
 Geometric Similarity: Ratio of all lengths constant
(constant fill ratio) Dynamic Similarity: Maintenance
of Forces (Froude number)
 Kinematic Similarity: Maintaining a consistent number
or revolutions Table 2, Scale-up in QbD Approach:
Blending Scale Amount (kg) Blender Capacity
Blending Speed (rpm) Blending Time (min) Nrev
Volume Fill Ratio (%) Laboratory 2 8 qt 25 12 300
~50 Pilot 40 7.5 cu.ft 15 20 300 ~50 Commercial 180
30 cu. Ft 10 30 300 ~50 Conclusion of case study 1:
The desired content uniformity was attained by
modifying the above parameters such as blending
speed and blending time.
 (Drug layering on MCC spheres) [3] Equipment
of production having greatest similitude
(geometric) to the intended to commercial scale
process, similar particle trajectories and
dynamics enables maintenance of process
parameters through scale-up with the exception
of air-flow which is linearly scaled (Figure 3,
Table 3). Conclusion of case study 2 Air flow rate
and total spray rate were adjusted to obtain
uniform coating of drug on MCC spheres. Assay
of the formulation was 99.9% in both pilot batch
and commercial batch.

Case Study 2
 • It is a United Nations Regional Institution under the
Economic and Social Commission for Asia and the
Pacific (ESCAP) established in 1977 in Bangalore,
India.
 In 1993, the Centre moved to New Delhi, India.
APCTT promotes transfer of technology to and from
small- and medium-scale enterprises (SMEs) in Asia
and the Pacific. APCTT implements development
projects funded by international donors aimed at
strengthening the environment for technology
transfer among SMEs. The objective of APCTT is to
strengthen the technology transfer capabilities in the
region and to facilitate import/export of
environmentally sound technologies to/from the
member countries.

Asian and Pacific Centre for

Transfer of Technology (APCTT)
 National Research Development Corporation
(NRDC) was established in 1953 by the
Government of India, with the primary
objective to promote, develop and
commercialise the technologies / know-how /
inventions / patents / processes emanating
from various national R&D institutions /
Universities and is presently working under
the administrative control of the Dept. of
Scientific & Industrial Research, Ministry of
Science & Technology.

National Research Development

Corporation (NRDC)
 TIFAC is an autonomous organization set up in
1988 under the Department of Science &
Technology to look ahead in technology domain,
assess the technology trajectories, and support
innovation by networked actions in selected
areas of national importance TIFAC embarked
upon the major task of formulating a Technology
Vision for the country in various emerging
technology areas. Under the leadership of Dr. APJ
Abdul Kalam, Technology Vision 2020 exercise
led to set of 17 documents, including sixteen
technology areas and one on services.
Technology information,
Forecasting and assesmement
Council (TIFAC)
 New Delhi was incorporated as public limited
company in 1990 under The Companies Act, 1956.
The consortium is promoted by the Department of
Biotechnology, Government of India and financed by
the All India Financial Institutions and some corporate
sectors BCIL 's major functions include the
development and transfer of technology for the
commercialisation of biotechnology products, project
consultancy, biosafety awareness and human
resource development BCIL has been successfully
managing several Flagship schemes and Programmes
of the Department of Biotechnology, Government of
India

Biotech Consortium India Limited

(BCIL)
 The Technology Bureau for Small Enterprises
(TBSE) is a platform for MSMEs to tap
opportunities at the global level for the
acquisition of technology or establishing
business collaboration. TBSE is a result of the
cooperative initiative of the United Nations’
Asian and Pacific Centre for Transfer of
Technology (APCTT) and Small Industries
Development Bank of India (SIDBI) in 1995.
TBSE also receives partial funding from the
Office of DC (SSI), Government of India.
Technology Bureau for Small
Enterprises (TBSE)/ Small Industries
Development Bank of India (SIDBI).
 Confidentiality Agreements The aim of a
confidentiality agreement is to protect all
information of party entering negotiations.
Before any concrete negotiations on the
transfer of a technology can really start all
parties involved must be able to evaluate
the technology offered. Both the
technological and the commercial
possibilities of the offer will thereby be
taken into account.
TT related documentation -
confidentiality agreement,
licensing, MoUs, legal issues.