The PPD research facility, which opened in Athlone in March, has been awarded manufacturer licences by the Irish Medicines Board (IMB ).
The licences support investigational medicinal products and marketed products, and provide laboratory certifications for quality control of medicinal products.
PPD’s Athlone facility was opened by Taoiseach Brian Cowen on Monday March 1, and will allow PPD to serve its growing client base in Europe and the Middle East. The company plans to create up to 250 positions for PhD level students, laboratory staff, and other clinical development professionals in the coming years.
“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, 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 €14 million 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 analytical testing laboratory conducts testing for clinical programmess and marketed products spanning all phases of drug development and builds upon more than 20 years of PPD laboratory expertise.
The licensing of the new facility in Ireland supports the growth of PPD’s contract research operations in Ireland, which already operates a medical communications safety call centre from Athlone.