White Paper

Demystifying Extractables Testing

By Graeme Proctor, Product Manager (Single Use Technologies), Parker Biosience Filtration and Nick Morley, Principal Scientist, Hall Analytical

HEPTINSTALL

The increased focus by biomanufacturers on smaller patient populations is driving the adoption of technologies and solutions that can improve flexibility and process efficiency while also lowering overall costs. As a result, the application of single-use technology (SUT) is growing rapidly, this technology is being used for a range of applications in drug development. Its benefits include reduced cleaning requirements, decreased plant footprint and capital investment, improved batch turnaround times, increased process flexibility, and a significantly lower risk of product cross-contamination.1 Yet, while SUT offers a number of advantages, there are also factors that must be considered when adopting an SUT strategy, such as the presence of extractables and leachables (E&L).

Various interested parties have developed guidances that discuss extractable analysis of single-use components/systems, each with subtle differences. It is critical that anyone utilizing SUT understands these differences and which testing approaches are most suited to the study goals.

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