The LineaDNA™ platform is LineaRx’s novel, enzymatic DNA manufacturing workflow capable of producing high-quality DNA for nucleic acid-based therapies, including mRNA, cellular and gene therapy, and DNA vaccines.
Unlike traditional plasmid DNA, which is produced using complex biological methods, LineaDNA™ is produced enzymatically, resulting in faster production times (days instead of weeks or months), and higher purity. Available from microgram to gram scale. Ability to use plasmid DNA or a synthetic DNA template.
LineaDNA™ is relevant to a broad array of advanced therapeutics, including:
• mRNA manufacturing – efficient mRNA synthesis begins with robust, high-quality DNA IVT templates. Our LineaDNA platform utilizes a proprietary PCR-based process to rapidly scale up DNA production in a 100% cell-free workflow. LineaDNA is ready for use in IVT without further modification, contains highly homogeneous poly-T tails and is rigorously quality-controlled. When paired with our Linea™ RNAP polymerase, the process maximizes yield and minimizes dsRNA impurities – substances known to elicit off-target innate immune responses – thereby enhancing the overall product quality and safety of the IVT process.
• DNA vaccines – DNA vaccine development relies on the rapid generation of high-purity DNA. Our LineaDNA’s manufacturing speed surpasses plasmid-based DNA, measured in weeks, not months. We ensure that each of our customer’s vaccine candidates meets stringent purity standards. Our rapid enzymatic approach significantly streamlines the development process, offering a scalable solution that can adapt to high demand, particularly in pandemic or outbreak scenarios.
• Cell and gene therapies – high-precision DNA is paramount for successful gene editing applications. Our enzymatic production process generates high fidelity blunt-ended DNA templates that are crucial for facilitating precise homology-directed repair (HDR) and can be produced as single-stranded or double-stranded DNA. This enhanced capability accelerates research and development cycles in genetic engineering and therapeutic interventions.
• Personalized medicine applications – in the era of personalized medicine, tailored therapies require the rapid production of custom DNA sequences. LineaDNA is designed to deliver high quality bespoke DNA constructs that match the needs of individual patients. Moreover, our unique, rightsized, scalable GMP facility for LineaDNA can be tailored to support personalized medicine manufacturing for both DNA or mRNA therapies. This specialized infrastructure ensures that every product is manufactured under the highest quality standards while maintaining the speed and efficiency demanded for individualized therapy development.
Good Manufacturing Practice (GMP) refers to a system that ensures products are consistently produced and controlled according to quality standards. At LineaRx, our GMP facility and Quality System are central to our operations, ensuring that all products—whether for research use or clinical application—meet the relevant regulatory and quality requirements.
Our facility is purpose-built to integrate our proprietary rapid enzymatic DNA production and post-processing technologies within a fully GMP-compliant framework. Paired with a comprehensive Quality Management System, this integration enables faster turnaround times with a high standard of quality.
We manufacture a broad range of linear DNA products for research, preclinical, and clinical applications. These include plasmid-free linear DNA constructs suitable for cell therapy, gene therapy, and vaccine development.
Yes. Our facility operates under full GMP compliance, supporting both preclinical and clinical-grade manufacturing. This ensures a seamless transition from R&D to IND-enabling studies and beyond.
Quality is embedded in every step of our process. We follow strict GMP protocols, maintain comprehensive documentation, and perform rigorous in-process and release testing. Our QA/QC systems and processes are designed to meet or exceed relevant regulatory expectations.
Yes. Our facility and processes are designed with scalability in mind, allowing us to support clients from early-stage research through to clinical trials and commercial production
LineaRx currently operates under ISO9001:2015 certification with relevant ICH Q7 standards guidance. ISO13485 certification activities are underway.
The LineaRx team prides itself on customer service and stands ready to support its customers from research to clinic with the required data, documents, regulatory expertise and filings as required through our customers’ scaleup.
Yes, we welcome our customers to visit our facility, operations, and speak with our team as needed during a research program or product scaleup.
For project inquiries, collaborations, or to schedule a visit, please contact our Business Development team at info@adnas.com
For more information, you can call LineaRx at (631) 240-8877 or email info@adnas.com
