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:10/5/2018)... ... October 04, 2018 , ... ... along with Duke University, announced today at IDWeek™ 2018 the positive results of ... pathogen DNA in plasma, accurately identified causative pathogens in patients with infective endocarditis ...
(Date:10/3/2018)... ... October 03, 2018 , ... Milwaukee Area Technical College (MATC), a public, two-year ... 3-7 p.m. in Room T129 in the T Building, 101 N. 6th St., to ... A ribbon cutting and formal program will be held at 4 p.m. , MATC ...
(Date:10/2/2018)... ... October 02, 2018 , ... Contamination ... the reliability and reproducibility of experimental data. Each lab must consider whether ethanol ... webinar, which is sponsored by Eppendorf , attendees will learn how to ...
(Date:9/28/2018)... (PRWEB) , ... September 28, 2018 , ... ... Services (PMLS) to increase the availability of the GlycoMark test, the only FDA-cleared ... diabetes. With the partnership, PMLS will promote and offer the GlycoMark test to ...
Breaking Biology Technology:
(Date:10/16/2018)... BOSTON (PRWEB) , ... October ... ... a global leader in delivering cloud-based enterprise-class unified communications and collaboration solutions, ... enhanced network stability by directly connecting CallTower data centers to a customers’ ...
(Date:10/11/2018)... (PRWEB) , ... October 09, 2018 , ... Exalto ... and marine industries, announces the appointment of Mike Cosgrove as Business Manager. , Cosgrove ... be responsible for the day to day running of the Derby UK facility. , ...
(Date:10/5/2018)... ... October 05, 2018 , ... The Amino Acid Technologies Division ... price increase across all markets in January 2019. , The global leader ... protein — for the parenteral nutrition, biopharmaceutical, infant/medical food, supplement and nutrition markets. ...
Breaking Biology News(10 mins):