GE Healthcare Introduces GMP-Accredited Carbon-14 Labeling Service
GE Healthcare announced the introduction of its GMP accredited custom radio-labeling service for the manufacture of carbon-14 labeled compounds. The new service is designed to meet the increasing needs of pharmaceutical researchers to support their GMP requirements in clinical trials from the earliest stages of drug development, and to provide the reassurance of complete documented traceability and accountability from the outset.
The service is provided from a newly commissioned facility in Cardiff, UK, accredited by the Medicines and Healthcare products Regulatory Agency to manufacture carbon-14 radio-labeled APIs to GMP.
"This step up to GMP accreditation for GE Healthcare's custom labeling service demonstrates our commitment to supporting the Industry's exacting standards for Quality and Safety in clinical trials," said Ger Brophy, General Manager of Discovery Sciences, GE Healthcare. "The investment in the new facility at Cardiff allows us to expand our existing range of ISO9001-compliant services to the pharmaceutical industry. The new service will help our customers satisfy increasing regulatory demands associated with pharmaceutical development as well as meet their own Quality Assurance requirements."
With more than 50 years experience in custom radiolabeling and a dedicated 60-strong team of highly-experienced chemists, GE Healthcare has synthesised over 30,000 unique carbon-14 labelled compounds.
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our Web site at www.gehealthcare.com/usen/index.html.
Source: GE Healthcare