Capillary gel electrophoresis (CGE) is a high-resolution, label-free technique for the quality control of mRNA-based therapies. Because the poly(A) tail plays a critical role in mRNA stability and translation efficiency, accurately detecting and quantifying tailless species is essential to ensuring therapeutic efficacy and patient safety. This article explores how to optimize the SCIEX BioPhase™ 8800 system and RNA 9000 Purity & Integrity Kit to achieve the resolution required for today’s advanced mRNA medicines. Key method parameters, including electric field strength, capillary temperature, and sample concentration, are examined to support reliable separation and impurity detection.
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.