PerkinElmer, Inc., a global leader focused on improving the health and safety of people and the environment, today announced that it has opened a second specialized Good Manufacturing Practice* (GMP) services facility. The Company has added this capability in response to expanded demand for custom radiosynthesis of potential drug compounds for ADME (Absorption, Distribution, Metabolism and Excretion) research studies.
PerkinElmer's GMP Radiosynthesis Services provide advanced expertise for the manufacture and synthesis of radiolabeled compounds to help pharmaceutical, biotechnology and contract research organizations (CROs) accelerate drug development. The addition of a second facility demonstrates the Company’s continuing commitment to providing the highest quality products and services to research communities. PerkinElmer inaugurated its first GMP compliant facility in late 2008 in Boston, and has now doubled its capacity for GMP based services, due to increased client uptake throughout 2009.
Richard M. Eglen, Ph.D., president, Bio-discovery, PerkinElmer, Inc., said, "PerkinElmer is pleased to announce this expansion of our GMP facilities to better serve our clients, through advanced services designed to improve and enhance studies of potential drug compounds. Radiolabeling of new drug candidates for ADME is a major tool that assists drug discovery researchers to better understand the distribution of the compound as it moves through the body."
He added, "With the cost of drug development remaining high, and the costs of potential failures further down the research pipeline growing, PerkinElmer is responding to increased pharma demand for stronger early indicators of potential success or failure to make better decisions regarding project advancement."
PerkinElmer's GMP Radiosynthesis Services support team leverages more than five decades of radioactive materials expertise as well as exacting regulatory and documentation compliance, along with a vast compound catalog for screening experimentation. PerkinElmer is a premier manufacturer of custom GMP radiolabeled compounds. Compounds are routinely 98-plus percent pure, and are provided with the goal of achieving 100 percent on-time delivery.
PerkinElmer's GMP Custom Radiosynthesis Services include:
- GMP synthesis for Phase I studies
- Non-GMP synthesis for preclinical animal studies
- Radiochemical stability testing
- Special packaging using NRC-approved PerkinElmer materials
- Analytical services
- Worldwide shipping
* GMP consistent with ICH Q7, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August, 2001, Section 19, API's for Use in Clinical Trials.