PPD said that the facility expands its global scientific expertise, laboratory capacity and supplies network to meet growing client demand in Europe, Middle East and Africa for these services.
PPD is expected to 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.
Additionally, the facility is also expected to provide regulatory services, product licensing and marketed product support, including qualified person (QP) services for all drug dosage forms, with particular emphasis on inhalation and biopharmaceutical products.
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. It joins the company’s scientific and therapeutic experience with facilities and instrumentation to deliver comprehensive, best-in-class laboratory services.
The facility represents PPD’s initial investment toward continued growth of its contract research operations in Ireland, having already expanded its medical communications safety call center operations into Athlone.
PPD said that it has already hired 21 employees in Athlone and plans to create approximately 250 jobs at the laboratory to include Ph.D.-level scientists, analytical laboratory staff and other clinical development professionals. The company is investing up to $19m to develop the facility.
Furthermore, PPD has applied to the Irish Medicines Board (IMB) for manufacturer licenses to support both investigational medicinal products and marketed products and laboratory certifications for quality control of medicinal products. As of March 1, PPD’s license applications have been assessed, and the quality system and premises inspected by the IMB. The progression of PPD’s applications are under active consideration by the IMB.
Magdalena Mejillano, vice president of laboratory services at PPD, said: “Expanding our laboratory operations into Europe enables us to continue to deliver on our strong history of providing quality work and customer service to our growing client base in this region.
“The Irish government, through IDA Ireland, has provided us strong support, and we continue to benefit from Ireland’s highly skilled work force and business-friendly climate. We are pleased to join Athlone’s strong, growing pharmaceutical and biopharmaceutical sectors.”