Applied DNA Completes GMP Facility for LineaDNA IVT Templates

Applied DNA Sciences, Inc. has announced the completion of its Good Manufacturing Practices (GMP) facility at its Stony Brook headquarters. This marks a new commercialization phase for its subsidiary, LineaRx. The facility is ready to receive orders for LineaDNA IVT templates, utilized in mRNA clinical trial material production. While the facility is undergoing final testing, full operational status is expected by the end of January.

The company is negotiating a GMP supply agreement with an mRNA therapeutic developer and reaffirms its strategic restructuring timeline aimed at sustainable growth and cost optimization. The GMP facility is projected to have an annual IVT template manufacturing capacity of 10 grams and revenue potential between $10 million and $30 million.

Applied DNA continues its strategic focus on the enzymatic manufacture of synthetic DNA and RNA polymerase for mRNA therapeutics production. The LineaDNA platform offers advantages of simplicity, purity, and scalability. The company is in a crucial business phase, launching its GMP facility as part of a comprehensive strategy.