News | March 18, 2024

Applied DNA Enters into Agreement With Alphazyme For Scale-Up Manufacturing Of Its Proprietary Linea RNAP, Progresses Towards GMP Linea IVT Production Start

  • Project To Increase RNAP Manufacturing Capacity and Reduce Unit Costs of Goods -
  • Project Slated for Completion Coincident with Company's Planned Initiation of GMP Manufacturing for Linea DNA IVT Templates

Applied DNA Sciences, Inc. (Applied DNA or the Company), a leader in PCR-based DNA technologies, and Alphazyme LLC (Alphazyme), a Maravai LifeSciences company (MRVI) and global provider of specialty enzymes used in the life sciences sector, have entered into an agreement under which Alphazyme will scale-up manufacturing of Applied DNA's proprietary Linea RNA polymerase ("RNAP"). Under the terms of the agreement, Alphazyme will perform manufacturing process development, enabling the scaling of Linea RNAP manufacturing from its current research scale to the commercial scale necessary to empower the Company's growing demand for the Company's Linea IVT platform.

The Linea IVT platform combines the Company's enzymatically produced Linea DNA IVT templates and its proprietary Linea RNAP to empower the manufacture of better mRNA faster. It enables higher target mRNA yields with reduced double-stranded RNA (dsRNA) contamination and simplified mRNA production workflows.

Dr. James A. Hayward, president and CEO of Applied DNA, stated, "As we progress towards the planned initiation of our GMP manufacturing capabilities for our Linea DNA IVT templates, we are seeing interest in our Linea IVT platform increase, which should drive the need for greater quantities of Linea RNAP. By leveraging our enzymatically produced Linea IVT templates to enable the sale of the higher value Linea RNAP, we believe Linea IVT presents a differentiated approach to monetizing the mRNA manufacturing value chain. The ability to manufacture Linea RNAP at a commercial scale is critical to the success of our approach. We believe Alphazyme's deep expertise in manufacturing high-quality enzymes makes them an ideal partner for this critical step in the evolution of the Linea IVT platform."

"This collaboration with Applied DNA is a testament to our shared commitment to advancing the manufacture of high-quality enzymes at scale to support the IVT manufacturing of mRNA," said Chad Decker, Vice President and General Manager of Alphazyme. "Our mission is to be the world's premier partner for custom, industrial-scale, molecular biology enzymes. We are excited about this partnership and the ability to support the manufacture of Applied DNA's Linea RNAP."

About the Linea DNA and Linea IVT Platforms
The Linea DNA platform is a completely 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 Linea RNAP to enable mRNA and saRNA 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 dsRNA contamination; and 3) simplified mRNA production workflows.

Source: Applied DNA Sciences, Inc