Tips for Successful Technology Transfer
In our last blog post, we defined technology transfer and its significance in the pharmaceutical industry. However, how do we implement the technology transfer so the outcome is a successful one? Paying great attention to detail in the factors that contribute to the exchange (from the sending unit to the receiving unit) is required throughout the stages of the transfer. A successful technology transfer is one that is profitable — meaning, the receiving unit is able to effectively and confidently use the technology for business gain.
Importance of the Facility Check-In
Before we give you tips on what to do and not to for a successful technology transfer, let’s zero in on the importance of the facility.
A thorough check-in with the receiving site should take place before any technology transfer takes place. This is the time for the sending unit to assess for any notable differences or similarities in equipment, methodology, and/or variances. From there, management should be able to form an opinion about the ease of adaptation or need for modification to the plan. A lot of the times, transfers fail because both parties fail to see the incompatibility and inflexibility between the receiving and sending units.
Things to Do for Successful Transfer:
- Plan your project– Just like any project, tech transfer requires proper planning and risk management. You want to have all your bases covered and a timeline to accompany it. This will avoid any temptation to rush too quickly into process transfer. Following a plan will also keep tasks prioritized and properly supported.
- Share information -It’s important for all units involved to share complete and inclusive data. This might take the form of raw data, development reports, regulatory submissions, and validation reports. In this situation, it is always better for the receiving site to receive more information than to have to work with insufficient information.
- Full Documentation- Each organization uses different document styles and templates–sometimes even different languages. Especially when it comes to global technological transfer, transferring documents can be a daunting and challenging process. In addition to different styles and languages, sites may use different management systems such as E2, Agile, or SAP just to name a few. Management should ensure the sites go full-length to ensure full documentation gets shared and passed on to the right hands.
- Healthy and Safety Review –Proper health and safety procedures should be conducted to ensure the site’s ability to handle the product safely and cGMP compliance.
- Complete Process Validation – Transfer the process efficiently so that any manufacturing site can adapt it.
- Keeping Records and Testing Batches – It’s important to test batches (just like you would test batches of cookies for the odd burnt batch). Testing confirms quality of the batches and controls for unwanted scenarios. An example of an unwanted scenario would be the lab unknowingly shipping a bad batch to the customer. The lab would have to deal with customer dissatisfaction, recall of the product, and violating regulatory warnings. Another benefit of testing batches is they prevent labs from mistaking a good batch for a bad batch. Once a batch is perceived to be bad, labs throw them away which result in environmental waste and loss of revenue.
Succeeding in technology transfer comes down to two things: having technological transfer network ready and a thorough understanding of the process before transfer. Keeping these two principles in mind along with the tips above will aid you in your journey. Technology transfer takes a lot of time, patience, precision, vigorous research, and a robust team but the outcome is an overarching competitive advantage in the industry.