- LineaRx, a subsidiary of Applied DNA Sciences (APDN, Financial), completes transition to U.S.-based supply chain.
- Over 75% of LineaRx's manufacturing components are now sourced domestically.
- Strategic move responds to the 2024 BIOSECURE Act and customer demand for reshoring biopharmaceutical manufacturing.
Applied DNA Sciences, Inc. (APDN) announced that LineaRx, its subsidiary, has successfully transitioned its supply chain to rely solely on U.S.-based suppliers for critical input materials used in its LineaDNA™ and LineaIVT™ platforms. This strategic decision aligns with the 2024 BIOSECURE Act and marks a significant step towards reshoring biopharmaceutical manufacturing operations in the United States.
As the largest producer of PCR-based cell-free DNA in the U.S., LineaRx now sources over 75% of its manufacturing cost components domestically, including DNA template materials and manufacturing enzymes. This move is expected to enhance supply chain resilience and reduce potential risks associated with international sourcing.
LineaRx's proprietary PCR-based platform enables rapid production of high-fidelity, cell-free DNA at scales ranging from milligram to multi-gram, catering to the development needs of genetic medicines, including mRNA/DNA products and cell/gene therapies. With the recent launch of GMP manufacturing services, LineaRx is well-positioned to meet the increasing demand for domestically produced genetic medicine components.
Despite the strategic benefits, the company highlights that 25% of its manufacturing components still depend on international sources. The overall market impact and financial results of this supply chain transition are yet to be observed as the reshoring trend continues to unfold within the biopharmaceutical sector.