Navigation Links
AMRI Launches Stand-Alone Service; Expanding Solutions for Impurity Analysis and Toxicology Risk Assessment
Date:10/12/2017

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.

About AMRI
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.

Read the full story at http://www.prweb.com/releases/2017/10/prweb14795802.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related biology technology :

1. Rosalind™ Launches the Next Era of Genomics
2. LabRoots Launches Month-long Campaign in Efforts to Push Breast Cancer Research Forward
3. IS&T Launches New Journal of Perceptual Imaging
4. Rosalind™ Launches the Next Era of Genomics
5. Institute of Food Safety and Health (IFSH) Launches Food Processing Center of Excellence in Chicago at Annual Meeting
6. Heritage Biologics launches innovative HBnow virtual care program
7. AcCELLerated Biologics Launches Distribution Partnership with CEP-Topical Gear T:25 Technology
8. BioPharma Institute Launches 5 Top U.S. Pharmaceutical & Clinical Research Industry Regulatory Compliance Courses as Parent Company Celebrates 20th Anniversary
9. The Refinery Launches 2nd Annual “Fueling the Growth” Competition
10. RoosterBio Launches New cGMP Stem Cell Product Portfolio, Maintaining Unwavering Commitment to Driving the Explosive Regenerative Medicine Industry
11. Jenway Launches Genova Bio Spectrophotometer for Life Science Applications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/9/2018)... ... ... Since their establishment in 2012, ambitions have been high at Nicoya Lifesciences. As ... last year, the company is thrilled to announce the release of their new OpenSPR ... private product launch event during the annual Protein Society Symposium in Boston on July ...
(Date:8/7/2018)... (PRWEB) , ... August 06, 2018 , ... PetPace ... a leader in pet genetic testing, today announced the launch of a groundbreaking study ... an extension of another ongoing general study of pregnant dogs sponsored by PetPace and ...
(Date:7/27/2018)... ... July 27, 2018 , ... ... and representatives of the Biotechnology Innovation Organization (BIO) met with U.S. Environmental ... “Proposal for a Toxic Substances Control Act (TSCA) Inventory Representation and Equivalency ...
(Date:7/25/2018)... ... July 25, 2018 , ... We are pleased to announce ... (FCNY) acquisition of several Erchonia low-level lasers, including both Lunula Lasers and FX ... experience. Their students receive comprehensive academic training and directly-supervised clinical experiences that ...
Breaking Biology Technology:
(Date:7/28/2018)... ... , ... Inthirani Arul, an evidence-based healer, today announces research results based on ... disorders. , Biomarkers for immune function, blood, as well as, inflammation, were assessed ... increase in overall immunity as seen by the rise in antibody levels , ...
(Date:7/26/2018)... (PRWEB) , ... July 25, 2018 , ... ... meeting for C-level biopharma executives on September 4, 2018 at The Hilton Boston ... leverage insight from real-life business development experiences and dissect the most relevant deals ...
(Date:7/26/2018)... ... , ... The University City Science Center announced today that ... October 1, 2018. , Mr. Zarrilli brings 35 years of experience from ... management and governance levels. With a proven record in strategy, organizational growth, business ...
Breaking Biology News(10 mins):