Author Archives: Tomas Kostelec

Eliminating the Analytical Bottleneck in Production and Purification of mRNA

COVID-19 has focused a spotlight on the ability of mRNA technology to accelerate vaccine development and approval (1). That same technology can hasten development and approval of other therapeutic classes, including cancer immunotherapy, protein replacement, and gene therapy. Fulfilling those opportunities imposes significant challenges on process developers and manufacturers to improve existing processes. Scale-up to produce millions of doses (tens of kilograms) compounds those challenges. Furthermore, every step of the journey requires high-performance analytical methods, to ensure patient safety and…