Applied DNA Sciences, Inc, a leader in PCR-based DNA technologies, announced that it has established a new high bar for the production of DNA with the manufacture and shipment of a multi-gram quantity of linearDNA in under six weeks. The quantity was produced by the Company’s LinearDNA platform under a large recurring purchase order with a global manufacturer of in vitro diagnostics that was announced in the first quarter of fiscal 2023 and is the largest single shipment of linearDNA to date. The Company expects to ship a final multi-gram quantity in the third fiscal quarter of 2023 to fulfill the purchase order earlier than contractually stipulated.
We believe that this production milestone underscores our LinearDNA platform’s capacity for the rapid, enzymatic production of DNA at very large scale that stands in stark contrast to the scalability bottlenecks and challenges associated with conventional plasmid DNA to support both high value biotherapeutic and lower price-point diagnostic applications,” stated Dr. James A. Hayward, president and CEO of Applied DNA Sciences.
Also Read: AbbVie Advances Upadacitinib (RINVOQ) to Phase 3 Clinical Trials in Systemic Lupus Erythematosus
“Building on our platform’s inherent advantages of speed and scale, we are concurrently pursuing platform optimizations and a timeline to cGMP (current Good Manufacturing Practices) that we believe will enhance linearDNA’s standing as an alternative source of DNA. The future of our LinearDNA platform will have it supplying the needs of the entire DNA demand curve, from GLP-grade (Good Laboratory Practices) product for in vitro diagnostics and biotherapeutic research and development to cGMP-grade, therapeutic DNA as a direct replacement for plasmid DNA-reliant nucleic acid-based therapies.”
The Company’s LinearDNA platform is focused on empowering the next generation of nucleic acid-based therapies. The platform uses a cell-free, enzymatic approach that confers the advantages of simplicity, purity, speed, flexibility, and scalability in a fractional footprint relative to conventional plasmid DNA (fermentation)-based manufacturing processes. The resultant DNA, known as linearDNA™, is currently produced at GLP-grade in volumes from micrograms to grams to support customers’ needs. The Company is pursuing a timeline for cGMP linearDNA production that will enable it to support customers from research and development and drug discovery through large-scale manufacturing for clinical trials and commercial use.
SOURCE: Businesswire