How do you know when you are ready to conduct an analytical method transfer (AMT)? It is a critical GMP activity paired with a number of risks. This article explains how to reduce the frequent risks of such a transfer in pharmaceutical companies.
What is an AMT?
An analytical Method Transfer (AMT) is part of an Analytical Technology Transfer (ATT). ATT includes the entire transfer process (production, packaging, laboratory,…). Per the USP, the transfer of test methods, also referred to as method transfer, is the documented process that qualifies a receiving laboratory to use a test method procedure that is originated in another laboratory (transferring laboratory). The purpose of the method transfer is to ensure that the receiving laboratory has the procedural knowledge and ability to perform the transferred test method procedure as intended.
There are typically 2 parties involved in this process:
The Sending Unit (SU): transferring laboratory, providing the analytical procedure that needs to be transferred
The Receiving Unit (RU): receiving laboratory, the internal or external laboratory need to be qualified for the analytical procedure
Types of analytical method transfer
Depending on where the analytical transfer takes place, there are 2 different types of AMTs:
AMT within the same company: one company with two different sites (e.g. two laboratories (R&D → QC) within one company).
AMT performed between two different companies: When one company (RU) acquires the rights to manufacture a product that is owned by another company (SU), it is necessary to transfer the existing technology (method, software,…) thoroughly and in a GMP correct way, in order to be allowed to manufacture the product.
The different steps during the transfer process
Familiarisation and training is the experience/demonstration of becoming familiar with the lab method, product, reagents, analytical techniques,… (There is a possibility that RU visits SU.)
Product transfer (co- or revalidation) involves performing laboratory tests to verify that a particular instrument, software program or measurement technique/method is working properly. The data is analysed as required by the protocol and determines if the acceptance criteria have been met. If the criteria have not been met, an investigation is performed by the RU.
Verification is an assessment whether a method is suitable under actual conditions of use. A verification must be conducted the first time that a laboratory employs a method for testing a specific sample type. Method verification is specific to the laboratory performing the testing and to the sample type being tested.
Application: after the transfer is completed, the method is suitable for use at the RU.
AMT is a challenge between different departments (QC, R&D, Product support, etc.) and/or companies. An analytical tech transfer is never accomplished by one department. Good cooperation and communication between the different departments is of high importance.
Attention points during an AMT
1. Method interpretation
The “information-transfer” process is one of the most critical steps in an analytical technology transfer. This step is especially important during familiarisation and training. There is a lot of contact and interaction between SU and RU at that moment. In this process it is crucial to give the right kind of instructions/information.
The main rule to minimise risks during the information-transfer process is that details are an added value. The method instructions should be defined as specific as possible. Some examples:
2. Budget - costs
Issues related to costs need to be considered before the transfer starts. Estimating the cost and duration of the project can be overwhelming, especially when it is the first time a company is handling a transfer. The following aspects need to be kept in mind during a first transfer:
Finding experts with a few years of experience in GMP, different test methods and laboratory techniques
Specific back-up laboratory equipment needs to be provided in the lab (RU). When there is an issue with the equipment, a lot of time can be lost. That’s why it is important to purchase back-up equipment/material at the earliest opportunity.
3. Unexpected circumstances
Keep in mind that by some unexpected circumstances the transfer can be promptly interrupt. For example, during a transfer between R&D and QC it is possible the first phases of an AMT (familiarisation, training and product validation) are already completed before the clinical study is finished. In phase 3 of the clinical study, the product is tested on humans compared to a placebo. A specific lot needs to be made for this test, which must also be tested in the laboratory. In that way, the transfer is already started to be able to release the first product batches. The clinical phase is not yet completed before the transfer is completed. In that case, the transfer will be canceled when clinical trials fail.
The communication between the transferring and the receiving site is the key to success in an analytical tech transfer. This is not always easy considering the duration of the tech transfer and the long distances involved. Communicating by email is a good way to get your messages across, but it may not be as persuasive as talking to someone face-to-face. Also video conferences or visiting the laboratory from the transferring site (SU) can help in the communication.
An analytical technology transfer is a relative long process with many steps that entail many risks. Keeping previous attention points in mind will definitely lower the number of risks easily affecting the transfer.
Jolien De Smedt
Consultant @ pi
Waters: Method Lifecycle Management Seminar