In this podcast, Kayleigh Hearse, Sr Mgr. Technical Projects, Capacity Expansion Pharma Production shares details of Baxter BioPharma Solution’s approximately $100 million expansion of its sterile fill/finish manufacturing facility located in Halle/Westfalen, Germany. Kayleigh explains many of the key attributes of the new building, key learnings and major considerations that took place throughout the planning phase.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.
Gene manufacturing platforms, patient-centric formulations, contract services, packaging innovations, and sterile filling lines are in the spotlight at CPHI Milan 2026.