There’s a common perception that technology transfer is essentially a complex “handoff.” In reality, it’s a highly collaborative process.
Sending and receiving teams must work in lockstep to establish everything from process understanding to material readiness and regulatory documentation — often in a matter of months.
Technology transfer is also subject to the shifting winds of the pharmaceutical industry.
Some trends are positive, such as tools for material management, modern manufacturing equipment, the use of advanced computer software in the industry for statistical analysis, laboratory and in-process results reporting, electronic material dispensing reporting systems and the widespread adoption of quality by design (QbD).
However, other factors may be a hurdle during technology transfer and require mitigation.
Below, the authors discuss some of the strategies that sponsors can employ to overcome these obstacles, emphasising process understanding, proactive supply management and partnership readiness.