With growing demand for advanced therapies, improved manufacturing processes are needed to provide flexibility and increase ...

The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...

D rug manufacturing has never been easy. But when Samuel Benoni Siegfried and his brother-in-law established the pharmaceutical factory Siegfried & Dürselen back in 1873, the range of drugs available ...

“The idea to process drugs in space isn’t new. Research showing that microgravity can impact crystallization has been done on ...

AI and ML tools are enhancing data management and process control in bio/pharmaceutical manufacturing, with early adoption in process development and emerging use in commercial manufacturing.

HENGDIAN, China, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Hengdian Group’s pharmaceutical arm Apeloa is using Flow Chemistry, a safer and more environmentally-friendly manufacturing approach than traditional ...

Ensuring the safety and quality of pharmaceuticals, such as blood products, vaccines, recombinant proteins, and monoclonal antibodies, is essential. Endotoxins act as a hidden ‘time bomb’ in these ...

President Donald Trump on Thursday said he will put import taxes of 100% on pharmaceutical drugs starting on Oct. 1.