Pharmaceutical Product Development (PPD), a global CRO based in Wilmington, N.C., has expanded its good manufacturing practices (GMP) operations in Athlone, Ireland, by adding a new, state-of-the-art laboratory for cell-based assays to its existing portfolio of services at the facility. The new lab provides GMP bioassay testing with dedicated areas to support cell culture activities with multiple assay endpoint expertise.
This expanded capability enhances the company’s ability to deliver global scientific and technical experience with expanded lab capacity to meet growing client demand for these services in Europe, the Middle East, Africa and the Asia-Pacific region. The same services already are available in the U.S. through its Middleton, Wis., GMP lab.
In addition to the new cell lab, the facility continues to provide fully integrated solutions for product development and analytical development, including analytical testing services in method development, validation, stability and release and quality control testing. The facility also provides 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 expansion of our GMP laboratory represents PPD’s ongoing investment toward continued growth of our operations in Ireland in order to offer enhanced service capabilities to our growing client base in this region and throughout the world,” said David Johnston, Ph.D., executive vice president of global laboratory services at PPD. “In addition, Ireland offers a business-friendly climate, highly skilled work force through its close proximity to the Athlone Institute of Technology and strong support from the Irish government, particularly IDA Ireland.”
PPD opened its Athlone laboratory in 2010 and, once the expansion is complete, will employ nearly 150 people at the facility, including Ph.D.-level scientists, analytical lab staff and other clinical development professionals. In total, PPD employs more than 1,000 people in its global GMP operations.
“The Irish life sciences sector has experienced significant growth in recent years, with more than $3 billion of investments committed across a broad scientific and regional spread during the last two years alone,” said Barry Heavey, Ph.D., IDA Ireland’s head of life sciences. “PPD’s expansion of its Athlone operations is an extremely welcome part of the renewed growth in the life sciences cluster in the Midlands, and supports IDA Ireland’s efforts to bring more high-quality, cutting-edge life sciences companies to our country.”
PPD also recently established a link with the National Institute for Bioprocessing Research and Training (NIBRT) and IDA Ireland to create targeted training and retraining for industry-experienced people in the biotech field to help them obtain the skills necessary to be considered for positions at the Athlone facility. The program is open to people at all levels from new science graduates to Ph.D.-level professionals who want to gain the necessary scientific and/or technical experience.
The Health Products Regulatory Authority (HPRA) has performed a full inspection of the new lab and has authorized PPD to perform cell-based assay services in Athlone. PPD already had been licensed by the HPRA to support both investigational medicinal products and marketed products and lab certifications for quality control of medicinal products.
PPD’s Athlone campus also includes a dedicated global clinical supplies facility, which offers packaging, labeling and storage to support clinical trials.
In addition to the GMP labs in Athlone and Middleton, PPD’s global laboratory services include: central labs in Beijing, Brussels, Kentucky and Singapore; bioanalytical labs in Middleton and Richmond, Va.; and vaccines and biologics labs in Richmond and Wayne, Pa.