DNA is not only the foundation of life. It’s also the foundation of modern medicine.
At LineaRx, an Applied DNA Sciences, Inc. (NASDAQ: APDN) company, we have a single purpose – to produce therapeutic DNA faster, of higher purity, and with greater scalability than current methods.
Therapeutic DNA is currently manufactured primarily via plasmids (pDNA), a complex biological method that has remained mostly unchanged for almost 40 years.
Our LinearDNA™ platform is a novel, enzymatic DNA manufacturing approach capable of producing high-quality DNA for nucleic acid-based therapies, including mRNA, Cellular and Gene Therapy and DNA Vaccines. We have named the resultant therapeutic DNA ‘LinearDNA’ or ‘linDNA’.
Our enzymatic approach and deep expertise in polymerase chain reaction (PCR) can dramatically accelerate innovation in nucleic acid-based therapies across a product lifecycle, from research and development to the clinic and commercial manufacturing.
The next generation of therapies require a next generation supply of DNA.
Enabling Nucleic-Acid Based Therapies
Our enzymatic LinearDNA platform enables us to make DNA at the Speed, Purity, Flexibility, and Scalability to support the rapid growth of nucleic acid-based therapies:
- Speed: days, not weeks or months
- Purity: 100% of produced DNA is comprised of the target therapeutic DNA sequence
- Flexibility: pDNA or a synthesis DNA template can be used
- Scalability: linDNA is available from the µg to g scale
One Platform Many Biotherapeutic Applications
mRNA Manufacturing
- Ideal template for mRNA production via IVT
- Enzymatic production results in a homogeneous product
- Potential to use less DNA to achieve equivalent mRNA yield
- Ability to produce DNA as long as 20kb
- Reduces manufacturing complexities
Cellular and Gene Therapy
- Ideal form of DNA for use as a component in the manufacturing of many therapies, including:
- Adoptive cell therapies
- Viral vector manufacturing
- CRISPR knock-in sequences
- Eliminates inclusion of unwanted plasmid DNA sequences into therapies
DNA Vaccines
- Provokes a strong humoral and cellular immune response at lower total DNA amounts than plasmid DNA
- Successful animal trials for both prophylactic and therapeutic vaccines
- Compatible with DNA delivery technologies such as lipid nanoparticles (LNPs) and electro-gene transfer
Next Gen Platform
While cutting-edge therapies continue to advance at breakneck speed, the manufacturing of DNA upon which they are reliant has remained largely unchanged in the past 30 years. linDNA, a new form of DNA for biotherapeutic applications, looks to upend current DNA manufacturing by harnessing the power of simple and scalable cell-free enzymatic DNA production. Cutting-edge therapies require cutting-edge DNA.
Speed of Manufacturing
linDNA’s cell-free enzymatic manufacturing platform enables multi-gram DNA production in weeks rather than months. Unlike plasmid-based DNA manufacturing, little optimization is needed to produce new DNA constructs.
Purity
Unlike pDNA, linDNA comprises 100% of the desired DNA sequence. Since linDNA is enzymatically produced, there is no need for a DNA backbone or inclusion of other unwanted DNA sequences.
Flexibility
Enzymatic manufacturing provides unparalleled flexibility in DNA production, with pDNA or a de novo DNA sequence usable as a template. linDNA is also easily chemically modified during manufacturing.
Scalability
linDNA’s enzymatic manufacturing platform is capable of producing DNA quantities necessary to support a nucleic acid-based therapy across its entire product lifecycle. linDNA is currently available from the µg to g scale. With its compact benchtop manufacturing equipment, linDNA production can rapidly scale to meet virtually any demand.