To manufacture quality drugs consistently, there is need to transfer necessary technologies and information. This process is referred to as technology transfer. It is a process of taking a certain invention from its birth in a laboratory and transforming it to a commercialized product.
In the pharmaceutical industry, the term technology transfer is used to coin all the processes that are required for successful development from drug discovery to product improvement to clinical trials to total commercialization. It is also understood as the process by which technology developers avail their technology to their commercial partners who in turn exploits it.
The process of technology transfer
Technology transfer is both critical and integral to the drug discovery and improvement process for new medicinal products. The decision to transfer such products between manufacturing sites is normally motivated by economics. The key stages of the process include;
1. Data collection
2. Data review
3. Regulatory impact (more emphasis on change approvals)
4. Analytical validation
5. Pilot or total process batch
6. Stability set down
In a typical research-based pharmaceutical company, the discovery of drugs and their development can be categorized into various stages namely; the research phase and the development phase.
Primarily, the research phase is just comprised of scientific research that will create new services and products that will benefit the public. After the initial research, the process goes to the development phase. At this stage, more research is done to decide whether the product has market potential and does market analysis to decide if there is customer need. Once the research has market potential, the opportunity is protected through filing for intellectual property protection. After licensing, commercialization begins and the service or product is brought to the market. This is the last phase; the production phase. Feedback from marketed products is also considered.
The stages of formulation are;
1. Pre-formulation studies
2. Bench scale- 1/1000th of Y
3. Lab scale – 1/100th of Y
4. Scale up- 1/10th of Y
5. Commercial- Y
Where Y – final commercial scale lot size
Importance of technology transfer
Illuminates important information to transfer technology starting from R&D to manufacturing by sorting out information obtained during R&D.
To elucidate crucial information to transfer technology of products on hand between various manufacturing places
To exemplify points of concern and certain procedures thereby, contributing to smooth technology transfer
Ensuring a successful technology transfer
To make sure that technology transfer in pharmaceuticals takes place successfully, there are certain items that should be challenged. Such include;
1. A safety and health review should be conducted to ensure the capability to handle the products safely.
2. Cleaning validation should be assessed. In addition, batch records and specifications should be well written.
3. Packaging line trials should be performed especially if a product is new to the site. Online transfer against the procedure signed off by the client should be enabled by indicating stability methods.
4. Operators should also be trained and QA agreements put in place. Timelines should also be adhered to and critical issues and events communicated.