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 […]

Webinar – Formulation & Delivery of Spray Dried Biologics Series

Session Overview: Join our panel of experts for a series of talks about the formulation and delivery of spray-dried biologics across oral solids, nasal, pulmonary and injectable (high concentration and encapsulated biologics) dosage forms. With four different 30-minute sessions, discover the benefits and applications of spray drying in the development and manufacture of biologics. What […]