Applied DNA Completes Buildout Of GMP Facility For LineaDNA IVT Templates
- Signals Start of New Commercialization Phase for LineaRx Subsidiary
- Company Negotiating GMP Supply Agreement
- Company Reaffirms Strategic Restructuring Timeline
Applied DNA Sciences, Inc. (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, today announced the completion of the buildout of its new Good Manufacturing Practices (GMP) manufacturing facility (the “facility”) within its Stony Brook, New York, headquarters and readiness to accept orders for the manufacture of LineaDNAIVT templates that clients can utilize for the production of mRNA clinical trial materials. The facility is undergoing final testing and is expected to be fully operational by the end of the current month. The Company also announced that it is actively negotiating a supply agreement for GMP IVT template with a mRNA therapeutic developer.
Separately, the Company reaffirmed its intention to complete the implementation of its previously announced strategic restructuring plan by the end of the current quarter. The restructuring is intended to drive sustainable growth from LineaRx, Inc., its biotherapeutic subsidiary, optimize Applied DNA’s cost structure, and extend the parent company’s cash runway.
GMP Facility Overview:
- Based on updated modeling, an initial projected annual IVT template manufacturing capacity of approximately ten (10) grams with 100% cell-free workflow;
- 10mg to gram-scale production in 6-14 weeks with multiple purification options;
- Dedicated warehouse, process development, analytical testing, and quality control areas;
- The capacity to deliver chemically modified LineaDNA IVT templates paired with the Company’s proprietary RNA polymerase to mitigate double-stranded DNA (dsRNA) contaminants in commercial-scale mRNA production; and,
- A projected revenue capacity ranging from $10M to $30M, depending on product mix (sales of IVT template or the paired-IVT template and LineaRNA polymerase for mRNA production [1].
“Once operational, our GMP facility stands ready to support the development of next-generation genetic medicines with a cell-free, enzymatic approach to IVT template production that confers the advantages of simplicity, purity, speed, flexibility, and scalability in a fractional footprint relative to conventional plasmid-DNA (fermentation)-based IVT template manufacturing processes. We believe we are in an unmatched position to help bring the advantages of synthetic DNA to our clients to develop innovative therapies,” stated Dr. James A. Hayward, chairman and CEO of Applied DNA.
Added Clay Shorrock, president of LineaRx, Inc., “We believe the upcoming operational launch of our GMP facility is a pivotal junction for the Company, representing the final piece of a multi-year business strategy to commercialize our LineaDNA and Linea IVT platforms and return us to a growth trajectory. With a strong GMP sales funnel for IVT templates and in active negotiations on our first supply agreement, we look forward to engaging with our therapeutic developer and CDMO customers to support their cell-free DNA needs.”
About the Linea DNA and Linea IVT Platforms
The Linea DNA platform is an entirely cell-free DNA production platform founded on Applied DNA’s long-standing expertise in the large-scale enzymatic production of DNA. Capable of producing DNA in quantities ranging from milligrams to grams, the Linea DNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the Linea DNA platform is free of the adventitious DNA sequences found in other sources of DNA, is rapidly scalable, and provides for simple chemical modification of DNA constructs. The Linea IVT platform combines DNA IVT templates manufacturing via the Linea DNA platform with a proprietary LineaRNAP to enable mRNA and sa-mRNA manufacturers to produce what Applied DNA believes to be better mRNA faster, with advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of double-stranded DNA (dsRNA) contamination; and 3) simplified mRNA production workflows.
[1] Based on internal Company data and modeling.
Source: Applied DNA Sciences