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 or it is the process by which a developer of technology makes its technology available to commercial partner that will exploit the technology.
The importances of technology transfer are:
* 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 applicable to the technology transfer through R&D and production of drug (chemically synthesized drug substances and drug products) and the technology transfer related to post-marketing changes in manufacturing places.
Various stages of formulation development were as follows
- Preformulation studies.
- Bench scale – (1/1000th of X)
- Lab scale – (1/100th of X)
- Scale up- (1/10th of X or 0.1M whichever is maximum)
- Commercial (X)
Where X is the final commercial scale batch size.
Typical process development work flow in pharmaceutical industry.
1. Research phase.
a. Quality Design.
2. Development phase.
a. Research for Factory Production.
b.Consistency between Quality and Specification.
c.Assurance of consistency through development and manufacturing.
d.Technology Transfer from R&D to Production.
3. Production phase.
a.Validation & Production.
b.Feedback from Production and Technology Transfer of Marketed Products.