Industry stakeholders support the agency’s effort to engage manufacturers earlier in facility development, but uncertainty remains on how the program will be implemented.
The expanded agreement adds a second U.S. manufacturing site and larger batch production capabilities to support later-stage clinical trials of Ratio’s radiotherapeutic.
Contract development and manufacturing organizations (CDMOs) are more critical than ever to the biopharmaceutical industry, providing essential outsourcing services to customers...
Audit readiness in pharmaceutical manufacturing isn’t just about documentation—it’s built into the physical condition of your facility every day. This webinar reveals how proactive...
As global and domestic pressures mount, Japanese drugmakers are looking to improve development timelines, manufacturing execution, and operational efficiency.
Big Pharma and contract development and manufacturing organizations are making large capital expenditures to build infrastructure supporting the wildly popular medications.
Industrializing the manufacturing of these complex therapies is critical to ensure scalability and commercial viability, says the Alliance for Regenerative Medicine.
The proposal also includes $9 million and 19 new full-time positions for the U.S. Food and Drug Administration to accelerate advanced pharmaceutical manufacturing.
To counter the Chinese government’s investment, the U.S. must make a coordinated effort to grow biomanufacturing base, argues a bipartisan commission created by Congress.
The pharma giant has added to its inventory of orforglipron in anticipation of a favorable regulatory decision by the U.S. Food and Drug Administration.
Raleigh-Cary and Durham-Chapel Hill secured the first and third spots, respectively, as the nation’s most competitive markets for the production of therapeutic biologics.
Faced with the increasing complexity of peptide programs, Japan’s drugmakers are turning to outsourcing in preclinical and early stages, contends Neuland Laboratories.
The framework for the development and approval of individualized therapies for genetic conditions has significant chemistry, manufacturing, and controls hurdles.
AI is helping life sciences manufacturers improve uptime, PM effectiveness, calibration planning, and reliability analysis. See where practical AI adds value in GMP asset management...
Software platforms can seamlessly integrate with emerging technologies to unlock efficiencies, strengthen sustainability and enable proactive prevention of disruptions.
Built-in ability to meet data integrity standards should be a central focus when selecting control systems and manufacturing execution systems for pharma manufacturing
Cell therapies in the U.S. operate within an evolving FDA regulatory playbook that is grounded in the long-standing drug GMP framework — 21 CFR Parts 210 and 211 —...
The pilot, which launched in April, has evaluated 46 facilities using one-day inspectional assessments as the agency looks to make its resources more targeted and efficient.
The agency cited the CDMO’s significant violations of current Good Manufacturing Practice regulations for finished pharmaceuticals at Simtra’s Halle/Westfalen facility.
