PPD Expands GMP Lab in Athlone, Ireland
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.
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. 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. Read the full text here.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
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July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
