EMA and FDA have revised their COVID-19 vaccine strategies in 2025, focusing on LP.8.1 and evidence-based approvals. This blog explores regulatory changes, manufacturer impacts, and what to expect moving forward.
Isolators and RABS both play critical roles in modern aseptic manufacturing, but their regulatory expectations differ significantly. FDA, EU, and ISO guidelines emphasize risk-based design, validated control measures, and procedural discipline.
