Company to extend its impurity assessments and control expertise to customers beyond offering as an accompanying service to support drug development programs across its Discovery & Development services, or API and Drug Product businesses
AMRI, a global contract research, development and manufacturing organization that partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life, will now be offering its impurity solutions as a stand-alone service. Several trends in analytical testing are being attributed to new regulatory requirements for all new drug products, including the finalization of ICH M7 earlier this year and the upcoming required compliance of USP 232 and USP 233 by January 1, 2018. ICH M7 provides a practical framework applicable to the identification, categorization, qualification, and control of these mutagenic impurities to limit potential carcinogenic risk and USP 232 and USP 233 provides direction related to Elemental Impurities-Limits and Procedures, aligning requirements mostly with the ICH Q3D.
“Offering our impurity solutions as a stand-alone service – beyond providing them as an accompanying service to AMRI’s Discovery & Development services, or API and Drug Product programs – will enable us to extend our comprehensive expertise, purpose-built technologies and resources to our customers for impurity assessments and control,” said John Iannone, director, extractables/leachables and impurities, AMRI. “We are committed to excellence and to being a true partner to the industry. It is our responsibility as a CRO/CDMO to combine our extensive knowledge with our high-end resources to ensure the safety and efficacy of our customers’ products and improve drug development efforts.”
With industry-leading analytical services, AMRI leverages its state-of-the-art resources and years of process knowledge to help customers manage and control impurities from a variety of sources. AMRI offers a systematic and scientifically sound service to help customers determine and quantify the impact of potential genotoxic impurities (PGI) and elemental impurities on the safety of a drug through toxicological risk assessments to mitigate downstream product risk. This ensures control of the right target analytes with accurate identification and appropriate specification setting.
AMRI applies high resolution mass spectrometry (HRMS) with liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) technology, as well as gas chromatography mass spectrometry (GC-MS); Orbitrap Q-Exactive LC-MS, providing both HRMS and high-resolution, accurate-mass (HRAM); and inductively coupled plasma mass spectrometry (ICP-MS), which enable coverage of a broad scope of impurities ranging from volatile to non-volatile organic compounds as well as elemental impurities. In addition, AMRI’s impurity experts have extensive organic synthesis and toxicology experience to identify, qualify and control impurities in a highly effective manner for certain challenging situations, such as impurity root-cause investigation during manufacture process or stability studies.
AMRI, a global contract research, development and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical and Solid State Services, API Manufacturing and Drug Product. For more information about AMRI, visit http://www.amriglobal.com.