AMRI to Expand Container Closure Integrity Testing Services into EU

The company aims to add the additional analytical services in the European Union throughout 2018.
Feb 22, 2018
By BioPharm International Editors

On Feb. 22, 2018, AMRI, a contract research, development, and manufacturing organization, announced expansion of its container closure integrity testing (CCIT) services into the European Union (EU). The company intends to build out custom laboratory space for CCIT in its Valladolid, Spain, analytical facility. Additional analytical services, including reference standards and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) stability testing, will follow later in 2018.

"Within the last several years, the life sciences industry has pivoted toward quantitative methods for integrity testing of sterile package systems, with regulatory agencies increasingly demanding these more modern technologies," said Mark Stier, head of analytical services at AMRI, in a company press release. "As our client base for this critical service continues to grow in Europe, this expansion is a logical step in our mission to provide comprehensive testing solutions to customers across the globe."

The company expects that the expansion of these services to the EU will complement its existing local capabilities in chromatographic analytical method development and the future build-out of reference standard ICH stability facilities at the site. The expansion strengthens the company's ability to provide services to European customers and to deliver a more comprehensive solution for drug discovery, development, and manufacturing.

The company will be exhibiting at the PDA Parenteral Packaging 2018 conference from Feb. 27-28, 2018 in Rome, Italy.

Source: AMRI

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