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A proper technology transfer (TT) is both essential and important to drug discovery and development for new medicinal products. It is also required 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 Technology transfer (TT) is defined as “The transfer of the manufacturing process for a new pharmaceutical Drug Substance (DS) and Drug Product (DP), respectively, from the transferring site (in this case R&D) to the receiving site or designated commercial manufacturing site.” 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.
Importance of Technology Transfer in Pharmaceutical Industry
– To elucidate necessary information to transfer technology from R&D to actual manufacturing by sorting out various information obtained during R&D
– To elucidate necessary information to transfer technology of existing products between various manufacturing places
– To exemplify specific procedures and points of concern for the two types of technology transfer in the above to contribute to smooth technology transfer. This is applies to the technology transfer through R&D and production of drug substances or drug products and the technology transfer related to post marketing changes in manufacturing places.
Reasons for technology transfer
– Lack of manufacturing capacity: The developer of technology may only have manufacturing equipment which is suitable for small scale operation, and must collaborate with another organization to do large scale manufacturing
– Lack of resources to launch product commercially: The original inventor of technology may only have the resources to conduct early-stage research such as animal studies and toxicology study, but doesn’t have the resources to take technology through its clinical and regulatory phases.
– Lack of marketing and distribution capability: The developer of technology may have fully developed the technology and even have obtained regulatory approvals and product registrations, but it may not have the marketing and distribution channels.
– Exploitation in a different field of application: Each partner may have only half of the solution i.e. the developer of the technology might be capable of exploiting the technology itself in the field of diagnostic applications and may grant exploitation right to commercial partner for the exploitation of therapeutics application.
Facets of technology transfer
a. Govt. labs to private sectors
b. Between Private sectors of same country
c. From Academics to private sectors
d. Between Academy, Private and Govt. sectors
Steps in technology transfer
During development of a formulation, it is important to understand procedure of operations used, critical and non-critical 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. Appropriate care during technology transfer is important to enhance drug quality as developed by R & D in final formulation as well as to assure quality for predetermined period of time. The various steps involved in technology transfer are given below:
A. Development of technology by R & D [Research Phase]
B. Technology transfer from R&D to production [Development Phase]
C. Optimization and Production [Production Phase]
D. Technology Transfer Documentation
