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Substantial increase in capacity and capabilities designed to support growing client needs
Wilmington, N.C. – Pharmaceutical Product Development LLC (PPD) has expanded its stability sample storage capacity and capabilities as part of its ongoing efforts to meet the growing needs of its biopharmaceutical clients. The expansion includes a 75 percent increase in capacity for aliquoting, storage and worldwide distribution of reference standard materials.
The new stability operation, which is located at the company’s good manufacturing practices (GMP) lab in Middleton, Wisconsin, was constructed specifically for pharmaceutical storage for its clients and has the capacity to be equipped with more than 120 new stability chambers. The operation will enable the PPD Laboratories GMP lab to offer a significant expansion of the more than 40 different temperature and humidity set points for routine International Conference on Harmonisation (ICH) stability storage conditions and will increase capacity for customized temperature and humidity, photostability and shipping (freeze/thaw) studies.
“The expansion of our stability chamber capabilities in Middleton is indicative of PPD’s ongoing efforts to meet the ever-increasing laboratory needs of our clients around the world,” said Jon Denissen, Ph.D., vice president, GMP Lab, PPD Laboratories. “The GMP lab is representative of PPD Laboratories’ exceptional scientific expertise, broad therapeutic experience and state-of-the-art facilities. During the 22 years we’ve had lab operations in Middleton, we’ve been able to successfully grow our operations due in part to the strength of the talent in the region and the supportive business environment.”
With the new stability operation, the company has the capability to expand to 150,000 cubic feet of chamber space, effectively doubling storage capacity for stability programs and for samples of commercially released products that are retained for quality control purposes. It also will allow the Middleton operation to create additional analytical lab space.
PPD Laboratories is a leading provider of chemistry, manufacturing and controls (CMC) laboratory services for all phases of drug development. The Middleton GMP lab provides fully integrated solutions for pharmaceutical product development, including analytical testing services, method development and validation, stability testing, quality control and release testing. In addition to small molecule testing, the laboratory is a market leader in the analysis of inhalation and biopharmaceutical/biologic products, as well as extractables and leachables testing. PPD maintains a GMP lab in Athlone, Ireland, to meet the CMC testing needs of the European market.
In addition to the GMP labs in Middleton and Athlone, PPD Laboratories has bioanalytical labs in Middleton and Richmond, Virginia; central labs in Shanghai, China; Brussels, Belgium; Highland Heights, Kentucky; and Singapore; a vaccine sciences lab in Richmond; and biomarker labs in Richmond and Highland Heights.
For a photo of the stability operation, click here.
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 18,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com.