Kudo Biotechnology
Applied DNA and Kudo Biotechnology, a leading global mRNA CDMO offering end-to-end cGMP mRNA manufacturing solutions, entered into a joint development agreement (the “JDA”) to integrate Applied DNA’s Linea™ IVT platform (the “Platform”) into Kudo Bio’s commercial mRNA manufacturing workflows.
Under the terms of the JDA, the Companies will seek to optimize mRNA quality, yields, and mitigation of contamination by double-stranded RNA (“dsRNA”) in an integrated workflow at manufacturing scale and establish a global co-marketing relationship. Upon successful completion of the JDA, the Companies plan to negotiate agreements to enable the commercial launch of the joint workflow in the second half of calendar 2024.
mRNA therapeutics offer benefits far beyond pandemic vaccines, including cancer vaccines, protein replacement, and cell and gene therapies. Swift development and delivery are crucial, as delays impact patient outcomes and commercial decisions by drug developers. Speedy production of cGMP grade high quality mRNA drug substance and drug product at an appropriate scale remains a challenge. One of the bottlenecks is the reliance on microbial fermentation to generate plasmid DNA (pDNA) which is used as the template for mRNA production, often slows market entry for new treatments.
Dr. James A. Hayward, president and CEO of Applied DNA:
“The JDA is an important first step in the enablement of the commercial availability of a differentiated mRNA workflow empowered by our powerful platform. We believe that upon completion of the work under the JDA, Kudo Bio will possess critical advantages in turnaround time, scalability, and dsRNA reductions as compared to other mRNA CDMOs.”
Molly S. McGlaughlin, CEO of Kudo Bio:
“We are excited to work with Applied DNA, a clear technology leader, to access cutting-edge technologies to significantly improve our customers’ cost of goods, speed to clinic, and overall safety to their patients!”