Applied DNA's LineaRx Subsidiary Stands Ready to Support the Reshoring of Drug Development and Manufacturing with U.S.-Produced Synthetic DNA
Applied DNA Sciences' (NASDAQ:APDN) subsidiary LineaRx has completed its transition to a U.S.-based supply chain for critical input materials used in its LineaDNA™ and LineaIVT™ platforms. This strategic move, responding to the 2024 BIOSECURE Act and customer demand, positions the company to support the reshoring of biopharmaceutical manufacturing operations in the United States.
As the largest PCR-based cell-free DNA producer in the U.S., LineaRx now sources over 75% of its manufacturing cost components domestically, including DNA template materials and manufacturing enzymes. The company's proprietary PCR-based platform enables rapid production of high-fidelity, cell-free DNA in quantities from milligram to multi-gram scale for genetic medicines development.
La controllata di Applied DNA Sciences (NASDAQ:APDN), LineaRx, ha completato la transizione verso una catena di approvvigionamento statunitense per i materiali critici utilizzati nelle sue piattaforme LineaDNA™ e LineaIVT™. Questa mossa strategica, in risposta al BIOSECURE Act del 2024 e alle richieste dei clienti, posiziona l'azienda a supporto del reshoring delle operazioni di produzione biofarmaceutica negli Stati Uniti.
Come il più grande produttore statunitense di DNA libero da cellule basato su PCR, LineaRx ora si approvvigiona per oltre il 75% dei costi di produzione da componenti nazionali, inclusi materiali per template di DNA ed enzimi per la produzione. La piattaforma proprietaria basata su PCR consente una rapida produzione di DNA libero da cellule ad alta fedeltà, in quantità che vanno dal milligrammo a più grammi, per lo sviluppo di terapie genetiche.
La subsidiaria de Applied DNA Sciences (NASDAQ:APDN), LineaRx, ha completado su transición a una cadena de suministro basada en EE.UU. para los materiales críticos usados en sus plataformas LineaDNA™ y LineaIVT™. Este movimiento estratégico, en respuesta a la Ley BIOSECURE 2024 y a la demanda de los clientes, posiciona a la compañía para apoyar la relocalización de las operaciones de fabricación biofarmacéutica en Estados Unidos.
Como el mayor productor estadounidense de ADN libre de células basado en PCR, LineaRx ahora obtiene más del 75% de sus costos de fabricación de componentes nacionales, incluyendo materiales para plantillas de ADN y enzimas de fabricación. La plataforma patentada basada en PCR permite la rápida producción de ADN libre de células de alta fidelidad en cantidades que van desde miligramos hasta varios gramos para el desarrollo de medicamentos genéticos.
Applied DNA Sciences(NASDAQ:APDN)의 자회사 LineaRx는 LineaDNA™ 및 LineaIVT™ 플랫폼에 사용되는 핵심 원자재의 미국 기반 공급망 전환을 완료했습니다. 2024년 BIOSECURE 법안과 고객 요구에 대응한 이 전략적 조치는 미국 내 생명공학 제약 제조업의 리쇼어링을 지원하는 위치를 확보합니다.
미국 최대의 PCR 기반 무세포 DNA 생산업체인 LineaRx는 현재 제조 비용의 75% 이상을 DNA 템플릿 재료 및 제조 효소를 포함한 국내 부품에서 조달하고 있습니다. 회사의 독자적인 PCR 기반 플랫폼은 유전 의약품 개발을 위해 밀리그램에서 다중 그램 규모까지 고충실도의 무세포 DNA를 신속하게 생산할 수 있습니다.
La filiale de Applied DNA Sciences (NASDAQ:APDN), LineaRx, a finalisé sa transition vers une chaîne d'approvisionnement basée aux États-Unis pour les matériaux d'entrée critiques utilisés dans ses plateformes LineaDNA™ et LineaIVT™. Cette démarche stratégique, en réponse à la loi BIOSECURE de 2024 et à la demande des clients, positionne l'entreprise pour soutenir le rapatriement des opérations de fabrication biopharmaceutique aux États-Unis.
En tant que plus grand producteur américain d'ADN libre de cellules basé sur la PCR, LineaRx s'approvisionne désormais à plus de 75 % de ses coûts de fabrication en composants nationaux, incluant les matériaux de matrice d'ADN et les enzymes de production. La plateforme propriétaire basée sur la PCR permet une production rapide d'ADN libre de cellules à haute fidélité, en quantités allant du milligramme à plusieurs grammes, pour le développement de médicaments génétiques.
Die Tochtergesellschaft LineaRx von Applied DNA Sciences (NASDAQ:APDN) hat den Übergang zu einer US-amerikanischen Lieferkette für kritische Ausgangsmaterialien, die in den Plattformen LineaDNA™ und LineaIVT™ verwendet werden, abgeschlossen. Dieser strategische Schritt, als Reaktion auf den BIOSECURE Act 2024 und die Kundennachfrage, positioniert das Unternehmen zur Unterstützung der Rückverlagerung biopharmazeutischer Produktionsprozesse in die Vereinigten Staaten.
Als größter in den USA ansässiger Produzent von PCR-basiertem zellfreiem DNA bezieht LineaRx nun über 75 % seiner Herstellungskosten aus inländischen Komponenten, darunter DNA-Vorlagenmaterialien und Herstellungsenzyme. Die firmeneigene PCR-basierte Plattform ermöglicht die schnelle Produktion von hochpräziser, zellfreier DNA in Mengen von Milligramm bis zu mehreren Gramm für die Entwicklung genetischer Arzneimittel.
- Completed transition to U.S.-based supply chain, reducing geopolitical risks
- 75% of manufacturing cost components now sourced domestically
- Largest PCR-based cell-free DNA producer in the United States
- Recently launched GMP manufacturing services
- Strategic positioning for growing domestic genetic medicine market
- 25% of manufacturing components still sourced internationally
- Potential increased costs associated with domestic sourcing
Insights
LineaRx completes US-based sourcing for DNA/RNA production materials, aligning with regulations and industry reshoring trends, while market impact remains to be demonstrated.
Applied DNA's LineaRx subsidiary has completed a strategic supply chain initiative to source critical input materials for its DNA/RNA platforms exclusively from U.S.-based suppliers. This reshoring effort directly responds to the 2024 BIOSECURE Act and aligns with broader industry trends toward domestic manufacturing in the biopharmaceutical sector.
The company has successfully transitioned its supply chain for DNA template materials and manufacturing enzymes to U.S. sources, which collectively represent over
LineaRx utilizes PCR-based technology that requires fewer critical input materials compared to alternative approaches, potentially offering enhanced supply chain resilience. Their production capabilities span from milligram to multi-gram scale, allowing them to serve both development and manufacturing needs for genetic medicines including mRNA/DNA products and cell/gene therapies.
The company positions itself as the largest PCR-based cell-free DNA producer in the United States, now with GMP manufacturing capabilities that conform to pharmaceutical quality standards. This combination of scale, domestic sourcing, and regulatory compliance could potentially appeal to biopharmaceutical companies looking to mitigate supply chain risks and navigate potential tariff impacts through reshoring initiatives.
While strategically aligned with market and regulatory trends, the announcement doesn't detail specific customer commitments or financial projections resulting from this supply chain transformation. The actual market response and business impact remain to be demonstrated as the broader reshoring trend in biopharmaceutical manufacturing continues to evolve.
- Pivot to U.S.-based Supply Chain for Critical Input Materials Completed -
STONY BROOK, NY / ACCESS Newswire / April 21, 2025 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA or the "Company"), a leader in PCR-based DNA technologies, today announced that LineaRx, Inc., the Company's majority-owned subsidiary, has completed a long-term initiative to source critical input materials for its LineaDNA™ and LineaIVT™ platforms from U.S.-based suppliers. The initiative, undertaken in response to the 2024 BIOSECURE Act and customer demand for a U.S.-based supply chain, comes as the biopharmaceutical industry increasingly considers reshoring manufacturing operations to the U.S. in response to potential tariff impacts and to ensure a stable supply chain.
"With the completion of our supply chain pivot, the LineaDNA platform is now engineered for speed, scale, and domestic sourcing. Localized production of our DNA template materials and manufacturing enzymes enables us to better position LineaRx as a trusted and reliable manufacturing partner for developing and producing genetic medicines," stated Clay D. Shorrock, president of LineaRx. "As the largest PCR-based cell-free DNA producer in the United States and with capabilities further enhanced by the recent launch of GMP manufacturing services, we believe we are well-positioned to support increased domestic development and manufacturing of a wide range of genetic medicines, ranging from mRNA/DNA products to cell and gene therapies."
LineaRx utilizes its proprietary PCR-based LineaDNA™ platform to rapidly manufacture high-fidelity, cell-free DNA used in the development and manufacture of genetic medicines in quantities ranging from milligram to multi-gram scale. By leveraging its PCR-based technology, which requires a minimal number of critical input materials, LineaRx has built a robust, U.S.-based supply chain inclusive of DNA template materials and manufacturing enzymes that represent over
About the LineaDNA™ and LineaIVT™ Platforms
The LineaDNA 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 LineaDNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the LineaDNA 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 LineaIVT platform combines DNA IVT template manufacturing via the LineaDNA platform with a proprietary RNA polymerase, 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.
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid ("DNA"). Using the polymerase chain reaction ("PCR") to enable both the production and detection of DNA, we operate in two business markets: (i) the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and the development and sale of a proprietary RNA polymerase ("RNAP") for use in the production of mRNA therapeutics; and (ii) the detection of DNA and RNA in molecular diagnostics and genetic testing services.
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Forward-Looking Statements
The statements made by Applied DNA in this press release may be "forward-looking" in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA's future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, the unknown future impacts of current and future tariffs and geopolitical agendas, the unknown future demand for its biotherapeutics products and services, the unknown amount of revenues and profits that will result from its LineaIVT™ and or LineaDNA™ platforms, the fact that there has never been clinical trial material and/or commercial drug product produced utilizing the LineaDNA and/or Linea IVT platforms, and various other factors detailed from time to time in Applied DNA's SEC reports and filings, including its Annual Report on Form 10-K filed on December 17, 2024, its Quarterly Report on Form 10-Q filed on February 13, 2025, and other reports it files with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
Applied DNA Sciences Contact:
Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
Web: adnas.com
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SOURCE: Applied DNA Sciences, Inc.
View the original press release on ACCESS Newswire
FAQ
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