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 PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.