FDA leadership churn and reported political interference eroded internal cohesion, contributing to resignations of senior career officials and a climate of dysfunction impacting scientific review ...
Regionalized early development affects clinical supply, analytical transfer, comparability strategies, and regulatory ...
This week's roundup features coverage from Excipient World and INTERPHEX, including discussions on proactive risk management, the rise of advanced modalities, and the integration of flexible, ...
Reports indicate White House approval to remove Marty Makary, reflecting internal discomfort with political fallout from provocative regulatory shifts and intensifying congressional and ...
Advancing Aseptic Precision: How Modern Filling Lines Elevate Sterility, Flexibility, and Throughput
Isolator-based Grade A/ISO 5 architectures minimize operator interventions, enabling robust contamination control and compliance with EU GMP Annex 1, FDA guidance, PIC/S, and ISO 14644. Lyophilization ...
As a critical raw material for our manufacturing operations, media and buffers sit at the heart of the supply chain. On the ...
In news, the FDA approved AstraZeneca’s Breztri Aeorsphere s the first and only single-inhaler triple maintenance therapy for ...
In this interview, Valerie Bandy, vice president of Pharmacy Solutions, Tecsys, discusses the complex operational realities ...
At INTERPHEX 2026, Mel Radford, Bethany Silva, and Jason Pennington explore data trust, cybersecurity, organizational barriers, and KPI-driven thinking in smart pharma manufacturing adoption. At ...
In part 4 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, gives a preview of the ...
Daniele Ansaldi, technical manager for Automated Inspection Machines at Antares Vision Group North America, outlines some of the challenges of performing visual inspections on prefilled syringes.
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