Contract Services

Applied DNA Sciences reaches new milestones in research and manufacturing of Linear DNA

Applied DNA Sciences Inc, among the world’s largest producers of linear DNA, has reached new technical milestones in the growth of its Contract Research (CRO) and Contract Manufacturing (CMO) businesses. In the past 12 months, Applied DNA has shipped over 8,000mg of PCR-produced linear DNA for use in Diagnostic and Therapeutic applications. The Company has completed, or is progressing through, key milestones of a growing number of therapeutics research contracts for companies producing DNA and RNA vaccines and adoptive cell therapies. Key milestones of success for these gene therapies are delivery of DNA effectively into a cell, expressing the gene product from that DNA and eventually demonstrating the desired clinical outcome.
These projects are following the typical preclinical biotherapeutic path of proving efficacy at small scale prior to securing larger production appropriate for clinical trials and deployment.
Most DNA-based therapeutic products, both approved and in development, rely on legacy science of plasmid and viral vector production methods that are time-consuming, carry the risks of bacterial toxins and triggering complications or unintended consequences. Several recent clinical trials have been halted by FDA due to unintended consequences of plasmid-derived DNA. As an alternative, Polymerase Chain Reaction (PCR), is a well-proven technique of DNA amplification first introduced in the 1980’s as an investigative tool in research and diagnostic laboratories. Applied DNA’s patented large-scale PCR production capability is a breakthrough for therapeutic applications as it has already demonstrated that PCR product can be made available very cleanly and at the scale required for population-scale diagnostics.
The most significant Applied DNA milestones recently achieved in this field come from work with multiple companies worldwide to qualify PCR-based linear DNA expression constructs for therapeutic applications. From these collaborative efforts, we have shown that linear DNA is effective in expression of genes in vivo.
These forms are in direct contradistinction to Applied DNA’s DNA tags for supply chains, which are too small to express proteins, have no means of entering cells or tissues, and contain none of the control elements necessary to do so.
This accomplishment is among the first times a linear DNA expression amplicon produced by PCR has demonstrated expression in vivo.
In all cases, companies in our pipeline have been driven to Applied DNA’s market position as an alternative to the current science of plasmid-produced DNA to gain PCR-based linear DNA vectors inherently superior to plasmid and viral vectors in several important aspects:
• Bacteria-free: Absence of bacterial plasmid contaminants or sequences of prokaryotic origin such as genes for antibiotic resistance,
• Speed: Shorter lead times (days) from vector design to large scale production,
• Custom design turnaround time: custom modifications in sequence during the PCR process to enable experimentation comparisons on therapeutic performance, and,
• On-site Production: patented platform for large scale production supports the feasibility of DNA production closer and tailored to the point of care to support the concept of personalized medicine.
“The milestones achieved to-date are a result of a multi-year business plan beginning with the acquisition of Vandalia Research assets three years ago. Now attracting new business at an accelerating rate and showing results that go toe-to-toe with legacy plasmid production is a major milestone for the viability of PCR-produced DNA for use in therapeutics,” said Dr. James Hayward, president and CEO of Applied DNA. “We will continue to work with companies developing therapeutics to expand the processes necessary to grow this business alongside our mainstay tagging business.”