Consists of three harmonised processes
Lonza has launched a microbial-based platform for the production of high-quality plasmid DNA vaccines and therapeutics.
The new pDNA production platform consists of three harmonised processes: fermentation, primary recovery, and purification, which reduces development time required for customised pDNA products compared with existing systems.
‘This innovative development platform offers the versatility of multiple host organisms in conjunction with the flexibility of optional on-site strain development services,’ said Edwin Davies, head of Lonza’s Microbial Research and Development Services.
The pDNA production begins with a fed batch, high cell density fermentation process compatible with multiple E. coli host organisms. This is followed by a novel primary recovery process performed under low shear conditions, which reduces process time and improves overall product quality and yield. Finally, Lonza has adopted a two-column purification platform based on the differential power of hydrophobic interaction chromatography.
For the production of insertion sequences-free (IS-free) pDNA, Lonza offers the pDNA platform with Clean Genome E. coli, which was bioengineered by Scarab Genomics from E. coli K-12 by deleting more than 15% of the K-12 genome to allow for increased product stability and host strain reliability.