WILMINGTON, N.C.--Pharmaceutical Product Development, LLC (PPD) 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 laboratory 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 expertise with expanded laboratory capacity to meet growing client demand for these services in Europe, the Middle East and Africa, and the Asia-Pacific region. By adding these services to its Athlone operation, PPD is able to provide clients in these locations with the same services already available in the U.S. through its Middleton, Wisconsin, GMP lab.
In addition to the new cell laboratory, 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."
The GMP laboratory conducts testing for clinical programs and marketed programs spanning all phases of drug development, and supports PPD's 30 years of global laboratory expertise. It is part of the company's exceptional scientific expertise, broad therapeutic experience, and state-of-the-art facilities and instrumentation that deliver best-in-class laboratory services for its clients.
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 laboratory staff and other clinical development professionals. In total, PPD employs more than 1,000 people in its global GMP operations.
"This is great news for Athlone and the Midlands," said Minister for Jobs, Enterprise and Innovation Richard Bruton TD. "Since bringing its state-of-the-art operations to Ireland five years ago, PPD has made a major contribution to the Athlone area. The company's ongoing expansion has brought a great boost to the area in the form of high-level jobs and I look forward to working closely with PPD as it continues to grow in Athlone. Bringing high-end jobs to the region is a key part of the Government's Action Plan for Jobs, and world-leading companies like PPD have a major part to play in this."
This development is supported by the Department of Jobs, Enterprise and Innovation through IDA Ireland.
"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 laboratory 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, China; Brussels, Belgium; Highland Heights, Kentucky; and Singapore; bioanalytical labs in Middleton and Richmond, Virginia; and vaccines and biologics labs in Richmond and Wayne, Pennsylvania.
About PPD
PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 13,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.
PPD Forward-Looking Statement
Except for historical information, all of the statements, expectations and assumptions, including statements, expectations and assumptions about the expansion of its GMP laboratory in Athlone, Ireland, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based and could cause actual results to differ materially from the forward-looking statements. Other important factors that could cause future results to differ materially include the following: the ability to attract, integrate, retain and train key personnel; competition in the outsourcing industry; rapid technological advances that make our services or capabilities less competitive; compliance with drug development regulations; changes in the regulation of the drug development process; PPD's ability to win new business; overall global economic conditions; economic conditions, research and development spending, and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; consolidation in the pharmaceutical and biotechnology industries; loss, delay or modification of large contracts; higher-than-expected cancellation rates; the rate of conversion of backlog into revenue; risks associated with and dependence on strategic relationships; actual operating performance; risks associated with acquisitions and investments; and the ability to control SG&A spending. PPD assumes no obligation and expressly disclaims any duty to update these forward-looking statements in the future, except as required by applicable law. These forward-looking statements should not be relied upon as representing PPD's estimates or views as of any date subsequent to the date hereof.
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