Ensuring effective assay transfer

Published: 1-Aug-2012

Ensuring that assay data collected in one laboratory is comparable with data collected in another is crucial to the new drug approval process. Liquid handling instruments are the most common cause of assay transfer failure, and errors can come from a variety of sources, such as the liquid handling instruments, operators and environmental conditions in the laboratory. These errors can propagate during assay transfer and significantly affect results.

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The role of liquid handling can be critical in effective assay transfer. Keith Albert, product manager, Artel, provides top tips to ensure data assay transfer can be achieved successfully within and across laboratories.

With the life sciences industry racing down the path towards globalisation and outsourcing, the importance of ensuring that assay data collected in one laboratory is comparable with data collected in another is more important than ever. Data collected from all over the world is used in the new drug approval process and development of clinical diagnostics is more frequently an international, multi-laboratory programme.

Ensuring that assays give the same results on different platforms or in different laboratories is one of the most complex activities performed in laboratories. Whether the assay transfer involves scaling up an assay to a higher throughput platform or moving an assay from a development to a quality control environment, assay transfer failures can result in significant delays in projects and manufacturing, additional costs and incomparable data. In today’s laboratory environment where time-to-market pressures, fierce competition and scarcity of resources are commonplace, steps must be taken to prevent unnecessary problems.

To ensure effective transfer, all elements of an assay must be carefully analysed and understood before the transfer is started. While differences in equipment, reagents, technique and interpretation of methodology are typically the focus of assay transfer preparation, less obvious variables, such as liquid handling instrumentation, are often ignored. However, liquid handling instruments are some of the most common laboratory devices and the most common cause of assay transfer failure.

The accuracy and precision of liquid handling instruments, such as pipettes and automated liquid handlers, cannot be taken for granted. Errors in liquid delivery can often go unnoticed, undocumented or misunderstood, and can come from a variety of sources, such as the liquid handling instruments, operators and environmental conditions in the laboratory. These errors can propagate during assay transfer and significantly affect results.

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