An Efficient, End-to-End Process for Plasmid DNA Purification 

Efficient downstream purification is critical for delivering high‑quality plasmid DNA (pDNA) for advanced modalities such as RNA vaccines, gene therapy, and cell therapy. This application note presents a robust, scalable end‑to‑end pDNA purification process using Sartorius technologies from in‑line alkaline lysis and clarification through chromatography, final polishing, and sterile filtration, achieving over 98% supercoiled (sc) pDNA and meeting regulatory expectations for critical quality attributes. 

Key takeaways:

• Discover a data‑driven, end‑to‑end pDNA purification workflow built on Sartorius technologies, including automated lysis, high‑performance clarification, chromatography, and final filtration. 

• Learn how at‑line monitoring with the PATfix^® pDNA Platform delivers real‑time insights into yield, integrity, and purity of sc pDNA, enabling reliable and scalable pDNA production. 

• Understand how precise control and analytics at each process step help ensure compliance with regulatory standards for advanced therapy manufacturing.