.png?width=109&height=108&name=Pharma%20(2).png)
.png?width=111&height=108&name=Medical%20Devices%20(2).png)
.png?width=84&height=107&name=IVD%20(2).png)
.png)
Share
Analytical method transfers (AMTs) are a critical step in the drug-development timeline. AMTs often occur due to sequential activities, such as methods transferred from discovery to pre-clinical, to clinical manufacturing, and finally to commercial manufacturing.
They also arise from parallel activities, including multiple testing sites involving formulation and process development, stability, and release testing. Consequently, method transfers are a natural part of project progression.
However, when planning the development timeline, the transfer of analytical methods is often taken for granted. If a method doesn’t perform as expected, it can consume precious days of investigative work to identify the problem and even more time to correct it.
To mitigate these issues, it’s crucial to understand and address common pitfalls in AMTs.
Key Parties in Analytical Method Transfers
Each technology transfer between two laboratories involves two main parties:
- Transferring Laboratory (TL):
The source or laboratory of origin for the analytical procedure. - Receiving Laboratory (RL):
The recipient of the analytical procedure.
At Quercus Labo, our experience in AMT processes has helped us identify several potential pitfalls:
Common Analytical Method Transfer Pitfalls and How to Avoid Them
Conclusion: Ensure Smoother AMTs and More Reliable Outcomes
Successfully navigating the transfer of analytical methods is essential for maintaining the momentum of drug development projects. By identifying and addressing common pitfalls, laboratories can ensure smoother transitions and more reliable outcomes.
