27 Apr. 2010
WILMINGTON, N.C. (April 27, 2010) - PPD, Inc. (Nasdaq: PPDI) today announced its contract research facility in Athlone, Ireland, has been awarded manufacturer licenses by the Irish Medicines Board (IMB). The licenses support investigational medicinal products and marketed products and provide laboratory certifications for quality control of medicinal products.
PPD opened its contract research facility in Athlone, Ireland, last month, in response to growing client demand from clients in Europe, Middle East and Africa for cGMP analytical testing services. The facility includes an 18,000-square-foot cGMP analytical testing laboratory and clinical supplies business.
"Achieving IMB licensing one month after opening our Athlone facility is a result of our scientific expertise, state-of-the-art laboratories and instrumentation, and commitment to excellence and regulatory compliance," said Magdalena Mejillano, Ph.D., vice president of laboratory services at PPD. "From our lab in Athlone, we will provide a full range of small- and large-molecule testing capabilities, including inhaled products, allowing us to meet the changing needs of our clients more efficiently and effectively."
The new facility will offer fully integrated product and analytical development services, including method development; validation; stability, release and quality control testing; and global clinical supplies services, including secondary packing, labeling and storage. The facility will also provide regulatory services, product licensing and marketed product support, including qualified person (QP) services for all drug dosage forms.
The cGMP analytical testing laboratory conducts testing for clinical programs and marketed products spanning all phases of drug development and builds upon more than 20 years of PPD laboratory expertise.