TRANSFER OF TECHNOLOGY

 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”
 It is a systematic procedure that is followed in order to pass the documented knowledge and experience
gained during development and or commercialization to an appropriate, responsible and authorized party.
 Technology transfer embodies both the transfer of documentation and the demonstrated ability of the
receiving unit (RU) to effectively perform the critical elements of the transferred technology, to the
satisfaction of all parties and any applicable regulatory bodies.
 Transfer of technology requires a documented, planned approach using trained and knowledgeable
personnel working within a quality system, with documentation of data covering all aspects of development,
production and quality control. Usually there is a sending unit (SU), a receiving unit and the unit managing
the process, which may or may not be a separate entity
 Technology transfer is helpful 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. It is the process by which an original innovator of technology makes it technology available to
commercial partner that will exploit the technology.
 In pharmaceutical industry, “Technology transfer” refers to the processes of successful progress from
 Drug discovery
 Clinical trials
 Product development
 Commercialization
 Technology transfer is important for such researcher to materialize on a larger scale for commercialization
especially in the case of developing product.
 Technology transfer includes not only patentable aspects of production but also includes the business
processes such as knowledge and skills.
 In pharmaceutical industry preparation of dosage form needs scale up 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 to 20-100 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.

 The transfer of technology could happen in following ways:

 Government labs to private sector firms
 Between private sector firms of same country
 Between private sector firms of different country
 From academia to private sector firms
Guidelines / importance of Technology transfer

 To elucidate necessary information to transfer technology from R&D to actual manufacturing by sorting out
various information obtained during R&D.
 Demonstration of necessary information to technology transfer from research and development to actual
manufacturing.
  To elucidate necessary information to transfer technology of existing products between various
manufacturing places.
 To exemplify specific procedures and points of concern for smooth technology transfer. For the smooth
manufacturing of commercialized products.
Reasons for technology transfer

 Due to lack of manufacturing capacity

 Due to lack of marketing distribution and distribution capability
 Due to lack of resources to launch product commercially
 Forming alliances with partners
 Forming alliances with partners with marketing and distribution capability.
 Exploitation in a different field of application
Steps in Technology Transfer Process

 During development of a formulation, it is important to understand procedure of operations used, critical and
noncritical 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.
Quality Design: For drug products the quality design resembles to design to design properties and functions such as

 Abolition of adverse reactions,

 Enhancement of efficacy,
 Assurance of stability during delivery and
 Data based on various data such as chemical and physical properties, efficacy, safety and stability obtained
from preclinical studies.
For drug substance the quality design is to define starting materials and their reaction paths and basic specification of
the drug.

Development Phase

 Research for factory production

 For manufacturing drugs with qualities as designed, it is necessary to institute suitable quality control
method and manufacturing method, after identifying unevenness factors to secure stability in the scale up
(validation) that is executed to realize factory production of drug designed on the basis of result from small
scale experiments.
Consistency between Quality and Specification -

 is to ensure in the products specification that the quality predetermined in the quality design is assured as
the manufacture quality, and the product satisfies the quality of design.
Technology Transfer from R&D to Production:
R&D provides technology transfer dossier; TTD document to product development laboratory; PDL, which contains
all information of formulation and drug product as given below:

 Master formula card (MFC)

 Master packaging card
 Master formula
 Specifications and standard test procedure (STPs)
Production Phase
Validation & Production

 Production is implemented after various validation studies verify that it is able to stably product based on
transferred manufacturing formula
 While the manufacturing facility accepting technology is responsible for validation, the research and
development department transferring technology should take responsibility for validation such as
performance qualification; PQ, cleaning validation, and process validation; PV unique to subject drugs.
Scale Up For Production:

 Scale up involves the transfer of technology during small scale development of the product and processes.
  It is essential to consider the production environment and system during development of process. Operators
should concentrate on keeping these things in mind that their segment of the production process running
smoothly if technology transfer is implemented thoughtfully. Effective technology transfer helps to provide
process efficiency and maintain product quality.

Feedback from Production and Technology Transfer of Marketed Product

 To accumulate technical information obtained from repeated production.

 The information of modify various standards.
 The improvement of process and products.
 The changes of specifications and methods.
 The technical information of reviewed and updated at regular intervals.
 Establish of adequate Feedback system.
Exhibit Batches:

 After taking scale up batches of the product, manufacturing of exhibit batches takes place. In case of exhibit,
batch sizes are increased along with equipment's and their processes. This is done for filling purpose in
regulatory agencies. The purpose behind to run three consecutive batches are to shows process
consistency, reproducibility and to demonstrate that the manufacturing process is under control throughout
all the stages.
Factors Influencing Technology Transfer
(A)Drivers for Technology Transfer

 Good business and manufacturing practices

 Potential for competitive pricing
 Strategic planning
 Promising market scale and accessibility
 Adherence to regulatory standards
 Skilled workforce
 Innovation - friendly environment with sound Intellectual Property Protection and Enforcement
 Proper access to information or increased information exchange
 Opportunities for contingency supply
 Access to new machinery, training, know-how and business partnership
(B) Barriers of Technology Transfer

 Lack of awareness knowledge and efficiency

 Lack of government focus low market
 Web access and scientific publication
 Cost of prequalification
 National security issues and restrictions on exports of particular technology
 Inadequate funding in important areas and possible treaties
 Labour issues

(C)Approaches to overcome barriers in technology transfer

 Commercializing publicly funded technologies

 Political stability and good transparent governance
 Research tool patents and freedom to operate for the public sector
 Appropriate Capital Markets
 Alignment with Economic Development Priorities
 Cooperative research agreements
 Possible treaty on scientific access
Success of Technology Transfer

 Communication
 Certainty
 Challenges
 Capacity
 Commitment