Biologics are manufactured from established cell cultures for disease treatment, but the FDA has specific expectations for ...

GERMANTOWN, MD AND CHICAGO, IL / ACCESS Newswire / December 16, 2025 / uBriGene Biosciences, a leading global lentivirus CDMO specializing in Advanced Therapy Medicinal Product (ATMP) GMP development ...

InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its software development and validation practices ...

Hamilton today announced the launch of GlucoSense, a breakthrough in bioprocess analytics that introduces the first reusable, in situ glucose sensor designed to deliver continuous, real-time ...

Digital engineering and modeling and simulation (M&S) are transformative approaches that enable precision, efficiency and ...

The FDA has qualified AI-Based Histologic Measurement of MASH, or AIM-MASH AI Assist — the first AI drug development tool — ...

Subject to TSX Venture Exchange (“ TSXV ”) approval, NurExone has engaged Russo Partners LLC, a New York–based strategic ...

Inaugural Members of the Akadeum CDMO Alliance: ElevateBio (R) and Charles River. Akadeum has collaborated with both CDMOs, establishing strong data sets demonstrating reduced impurities and high ...

The study makes clear that regulators expect human oversight to remain central to pharmaceutical quality assurance. Human operators must participate at key control points and retain authority to ...

Collaboration with Science Tokyo spinout underscores GlycoNex's integrated antibody development and manufacturing capabilities in support of first-in-class immunotherapies NEW TAIPEI CITY, Taiwan, Dec ...

Innovation drives speed in early phase drug development. ICON’s Accelerated Pharmaceutical Solutions integrate advanced ...

SCTbio , a leading European CDMO specializing in GMP manufacturing for cell-based products, and Fortrea , a leading global contract research organization (CRO), today announced a strategic ...