Supercoiled DNA percentage: A key in-process control of linear DNA template for mRNA drug substance manufacturing

• Main Authors: Xijun Piao (Author), Yujie Tang (Author), Xiuzhi Li (Author), Weicheng Zhang (Author), Wei Yang (Author), Xining Xu (Author), Wenjing Wang (Author), Jiajia Jiang (Author), Jun Xu (Author), Kunkun Hu (Author), Meiling Xu (Author), Mengjie Liu (Author), Mengfei Sun (Author), Lin Jin (Author)
• Format: Book
• Published: Elsevier, 2024-06-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The development of messenger RNA (mRNA) vaccines and therapeutics necessitates the production of high-quality in vitro-transcribed mRNA drug substance with specific critical quality attributes (CQAs), which are closely tied to the uniformity of linear DNA template. The supercoiled plasmid DNA is the...