Sterile at Speed: Phase I Development in a Post Annex 1 Environment

Securing sterile drug product capacity for early-phase development has never been more challenging. The revised EU GMP Annex 1 guidelines have raised expectations across contamination control, environmental monitoring, and aseptic process validation at precisely the moment global sterile capacity is under its greatest strain. For early-stage biotech and emerging pharma, the impact is immediate. Timelines […]