It is well documented, that the transfer of processes from one site to another can cause significant bottlenecks in bioprocess development. Technology transfer also represents one of the highest risk areas which can delay execution of bioprocess development projects. This includes both the first technology transfer from the client to the partner, as well as the final technology transfer of the locked process from the partner back to the customer.
A successful technology transfer requires the commitment of time and resources from both you and your partner in many areas. Attention to detail when planning the technology transfer is key.
A successful technology transfer includes plans around the following:
- Sufficient and accurate technical information describing your process
- Planning logistics around material transportation and ordering supplies and any necessary equipment
- Clear understanding of regulatory requirements for exchange of materials between sites
- Sufficient resource allocation
The time and effort spent mapping out all logistics required for your process are well worth the investment. As an example, you should obtain a clear understanding of shipping schedules of equipment required to run your process, along with any required consumables. These should be prospectively identified. Ordering and receipt of the appropriate materials should occur well before a transfer is scheduled.
Take a closer look at historic delivery timelines from the vendor and incorporate those into your overall plan. Discuss who will be sent to train you or CMO staff, and how much time will be allocated for the training.
Cytiva is here to help you in designing, optimizing, and transferring scalable processes from pre-clinical to cGMP commercial manufacturing.