PPD Expands GMP Lab Services In Athlone, Ireland
Published: Oct 20, 2016
Enhances inhalation, small molecule and biopharmaceutical/large molecule analytical testing
WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD), has expanded its good manufacturing practices (GMP) laboratory operations in Athlone, Ireland, as part of its ongoing efforts to meet clients’ capacity needs and enhance its range of lab services offerings.
“The expansion of the Athlone GMP lab represents our ongoing investment in the continued growth of our contract research operations in Ireland and around the world to provide our clients with best-in-class laboratory services and state-of-the-art facilities and instrumentation”
The lab, one of the largest of its kind in Europe, has added 400 square meters (4,300 square feet) of new laboratory space for analytical testing of biopharmaceuticals and inhalation devices. The Athlone GMP facility now totals more than 3,800 square meters (41,500 square feet) of analytical testing and support space.
“The expansion of the Athlone GMP lab represents our ongoing investment in the continued growth of our contract research operations in Ireland and around the world to provide our clients with best-in-class laboratory services and state-of-the-art facilities and instrumentation,” said David Johnston, Ph.D., executive vice president of global laboratory services for PPD® Laboratories. “Our ability to deliver global scientific, technical and development expertise with expanded laboratory capacity enables us to meet the growing demand for these services in Europe, the Middle East and Asia-Pacific.”
The Athlone GMP lab provides fully integrated solutions for pharmaceutical product development, including analytical testing services, method development and validation, stability testing, and quality control and release testing. The operation 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.
PPD Laboratories opened its Athlone laboratory in 2010 and, with the completion of this latest expansion, will employ nearly 200 people at the facility, including Ph.D.-level scientists, analytical laboratory staff and other clinical development professionals. PPD Laboratories maintains another GMP lab in Middleton, Wisconsin, that offers all the same services as the Athlone lab. In total, PPD employs more than 1,300 people in its global GMP operations.
“PPD has been a valuable member of Ireland’s business community, and particularly the Athlone region, since opening its world-class facility in 2010,” said Minister Mary Mitchell O’Connor of Ireland’s Department of Jobs, Enterprise & Innovation. “Through this facility and the people it employs here, PPD plays an important role in maintaining the economic vitality of our Midlands region and developing the scientific, analytical, clinical and logistical skills of the professionals who support the biotech and pharmaceutical sectors in the Midlands life sciences cluster.”
“PPD’s expansion of its GMP operations in Athlone is warmly welcomed by IDA Ireland and adds to the continued growth of life sciences in the Midlands,” said Barry Heavey, Ph.D., IDA Ireland’s head of life sciences. “This is another important investment for a regional location, and IDA looks forward to working with PPD to ensure continued success and development.”
The Athlone lab is licensed by the Health Products Regulatory Authority (HPRA) to support both investigational medicinal products and marketed products. It also is certified for quality control of medicinal products, including cell-based assay services for biologics.
In addition to the GMP labs in Athlone and Middleton, PPD Laboratories includes: central labs in Shanghai, China; Brussels, Belgium; Highland Heights, Kentucky; and Singapore; bioanalytical labs in Middleton and Richmond, Virginia; a vaccine sciences lab in Richmond; and biomarker labs in Richmond and Highland Heights.
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 18,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. 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.