AMRI to expand container closure integrity testing services into EU

26 February 2018 (Last Updated February 26th, 2018 10:11)

US-based global contract research, development and manufacturing organisation AMRI is expanding its container closure integrity testing (CCIT) services into the European Union (EU).

US-based global contract research, development and manufacturing organisation AMRI is expanding its container closure integrity testing (CCIT) services into the European Union (EU).

The company work in partnership with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life.

As part of the expansion, AMRI intends to build out custom laboratory space for CCIT in its analytical facility in Valladolid, Spain, while additional analytical services, including reference standards and ICH stability testing, will be added later this year.

“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.”

AMRI analytical services head Mark Stier said: “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.

“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.”

In the EU, the expansion of these services will complement the existing local expertise in chromatographic analytical method development, as well as the future build-out of the reference standard and ICH stability facilities at the site.

The expansion will help the company to provide its complete suite of services to customers in the EU, as well as offer a more comprehensive solution for drug discovery, development and manufacturing.

AMRI will also be exhibiting at the PDA Parenteral Packaging 2018 conference from 27 to 28 February in Rome, Italy.