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 ...

Reports indicate White House approval to remove Marty Makary, reflecting internal discomfort with political fallout from provocative regulatory shifts and intensifying congressional and ...

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 ...

AI is transforming drug discovery and manufacturing, with agentic systems and digital twins enhancing efficiency and decision-making. Geopolitical uncertainties are driving supply chain ...

In this interview, Valerie Bandy, vice president of Pharmacy Solutions, Tecsys, discusses the complex operational realities ...

Vice President Pharmacy Solutions at Tecsys. With a career marked by this steadfast leadership, she has consistently excelled ...

In part 4 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, gives a preview of the ...

Looking at the wider industry landscape, Sanderson acknowledges the extraordinary level of activity currently reshaping the ...

In this episode of Manufacturing Intelligence, we break down digital twin use in pharma, from risk reduction and scale-up ...