Technical Transfer in Drug Development

Technical transfer is becoming more common, as more and more tasks in the pharmaceutical and biopharmaceutical industries are outsourced or transferred between sites within an organization. It takes time, and therefore money, to undertake a technical transfer, and it is important to complete the transfer on time and within budget. Technical transfers must be carried out in a manner that does not compromise any future NDA, ANDA or SNDA filings. Technical transfer in the context of pharmaceutical product development can include the manufacture of the API, or finished product, analytical methods, final release testing, etc. Even if only the API or product manufacture is to be transferred, this will involve in-process control tests. Some in-process tests use pre-calibrated equipment and do not require a formal transfer protocol, e.g. sieve analysis, tap density. However, other methods such as impurities, residual solvents, dissolution testing and assay will require a formal transfer protocol.

Formal technical transfers do not happen overnight. Sufficient time should be allotted within the project to allow for the proper completion of the transfer. Since little can be done if insufficient data were collected during the transfer, it is imperative to have well-written, comprehensive transfer protocols. Besides the transfer protocols, transfer reports should also be written. If the transfer is in conjunction with a move to validated commercial manufacture, then reports will be required at the pre-approval inspection, or a plan to show when they would be produced.

FinnBrit Consulting has the practical experience and in-depth knowledge to assist with technical transfer projects.

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