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Linearized DNA CMC to GMP

Linearized plasmid DNA manufacturing services designed to support the production of mRNA vaccines and therapeutics from preclinical development through commercial GMP supply.

Proprietary Technology to Guarantee Poly(A) Purity

Linearized DNA manufacturing workflow Clinical development timeline and comparison of ProPlus Process with Process 1.0 for linearized DNA manufacturing. IIT IND Phase I Phase II Phase III BLA/NDA Commercial ProPlus™ Process Process 1.0 Manufactured through E.coli fermentation: •  Plasmid will be digested directly with in process control •  Reduced purification steps (in comparison to Process 1.0) to improve recovery rate •  An increase in yield (2~3 times higher than Process 1.0) •  As fast as 2 weeks from strain construction to linearized DNA conditional release Manufactured through E.coli fermentation: •  Separate manufacturing and QC release for plasmid and linearized DNA •  Suitable for long-term storage due to the stable structure of plasmid •  As fast as 3 weeks from strain construction to linearized DNA conditional release PowerS™ PolyAssure Our proprietary strain and backbone has been optimized to ensure poly(A) integrity IntegraBone Poly(A) tail plays an important role in maintaining stability and expression of mRNA in a typical biological process. The poly(A) tail in mRNA is directly transcribed from linearized DNA. Therefore, poly(A) control in plasmid is essential. ProBio’s proprietary PowerS™–PolyAssure strain and IntegraBone are able to guarantee poly(A) purity.
Enhancing Long Poly(A) Plasmid Stability with ProBio's Proprietary PowerS™ Strain and Backbone
White paper on challenges and solutions in polyA control for mRNA
Flyer on cell-free technology for linearized DNA manufacturing
Flyer on optimized solutions for linearized DNA manufacturing
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