04.12.25 -- Cell & Gene Best Of March

The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies. It becomes effective July 23, 2025.

The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?

Over the past few years, the pharma/biotech industry has seen a significant shift from internal to external manufacturing. Examine the driving factors for what to expect in 2025 and beyond.

Explore advanced fluid management for cell culture freezing, cell banking and cell therapy.

The FDA's new FAQ offers crucial insights into best practices, from regulatory meetings to quality control and preclinical studies. Dive in for expert guidance.

Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.