4basebio’s synthetic DNA manufacturing process: Safe, scalable and GMP-ready DNA
From cell and gene therapies to next-generation vaccines and gene editing platforms, the quality, scalability, and reliability of DNA manufacturing directly influence the speed of innovation and the safety of patients. Yet most DNA used in advanced therapeutics today is still produced using legacy fermentation-based processes, these methods were never designed for the precision, flexibility, and regulatory demands of today’s genetic medicines.
This whitepaper provides deep technical insight into 4basebio’s synthetic DNA manufacturing process and how it differs from incumbent plasmid DNA production. We examine the underlying enzymatic DNA synthesis technology, critical quality attributes, scalability considerations, and regulatory considerations of moving from plasmid DNA to synthetic DNA produced in a GMP environment.