Industry subject matter experts spoke about the challenges of turning complex molecules into medicines patients can reliably ...

The pharmaceutical supply chain is a complex system with high stakes. USP provides insights on how it is helping industry ...

Jaenisch, Muraru, and Pandey discuss how regulators will audit pharma against its own AI policies and ways QA and regulatory ...

Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them ...

USP’s Sheehan and Liu talk at AAPS PharmSci 360 abou getting novel excipients past the monograph hurdle through early engagement with FDA.

CDMOs announced expansions, exhibitors showcased automated equipment, and supply chain strategy discussions were a focus at ...

Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.

Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and ...

In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for ...

Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.

Structural modifications can improve peptide stability, solubility, and absorption to enable effective oral delivery. Peptide therapeutics, once a niche segment of the drug market, have taken center ...

Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.