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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.