News & Updates

The success of a cell therapy extends well beyond development and GMP manufacturing. It also depends on the ability to deliver the product safely, reliably, and under tightly controlled conditions. Unlike traditional pharmaceuticals, cell therapies are highly...

By 2025, the global advanced therapy medicinal products (ATMP) sector, encompassing cell therapies, gene therapies, and genetically modified cell-based medicines, has progressed from early scientific success to clinical and commercial reality. Following a decade of...

In the European Union (EU), the release of medicinal products for commercial supply is a highly regulated activity. Central to this release process is the Qualified Person (QP), a legally defined role under EU pharmaceutical legislation. The QP is responsible for...