Element Materials Technology Launches New Pharmaceutical Testing Service

On March 21, Element Materials Technology launched its Rapid Response Pharmaceutical Testing Service in its Manchester laboratory, providing expedited testing for customers around the world. The service will focus on various testing requirements, including active pharmaceutical ingredients (API) and final drug products, extractables and leachables, degradation production, and elemental impurities.

Aerial shot of Manchester UK on a beautiful summer day during pandemic lock-down | Image Credit: © zaeball - stock.adobe.com

"We understand the critical importance of timely and precise testing in the pharmaceutical industry, and our new service is designed to address these needs head-on,” said Iain Gibb, general manager at Element’s Manchester, U.K. laboratory, in a press release from the company.

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Element released a case study of its new testing service, which was done using headspace gas chromatography–mass spectrometry (HS-GC–MS). The company used HS-GC-MS to identify a volatile organic substance, cyclohexanone, a precursor typically used in the production of solvent-based adhesive (1). Additionally, an extraction study of the infusion bag port showed that the amount of cyclohexanone in the component could potentially harm patients.

The move to open a new pharmaceutical testing service comes as the market for pharmaceutical testing services grows. The global market for pharmaceutical testing and outsourcing services was valued $8.3 billion in 2023, according to Grandview Research. The market is expected to grow at an 8.4% compound annual growth rate between 2024–2030, according to the report. This growth can be attributed to increasing focus on pharmaceutical quality, regulation, and prices.

“Increasing R&D investment is one of the critical sustainability strategies adopted by market players,” according to the Grandview Research report. “As, not all companies have an infrastructure for analytical testing. Therefore, outsourcing these operations is a suitable option, which helps to save time and cost.”

Element has already been investing in growing its testing capabilities. The company has doubled the size of its presence in the Americas since 2020 and recently opened a new facility in Cincinnati, Ohio, according to a press release. It has also made nine acquisitions since 2021.

In February 2024, the company announced that it would begin emissions testing services in the Netherlands. The country’s industrial landscape and the Dutch Government’s target to reduce CO2 emissions by 55% by 2030 makes the country ideal for Element’s emissions testing capabilities, according to a company press release.

Reference

(1) Ludlow, M. Characterization of Adhesive Related Leachable Deriving from Medical Infusion Bag. Element Materials Technology 2024. https://www.element.com/nucleus/2024/characterisation-of-adhesive-leachable (accessed 2024-3-21)