North Dakota Patent of the Month – October 2025
A major breakthrough in genetic medicine standardization is poised to accelerate gene therapy development. U.S. Patent Application No. 20250333807 reveals a single, universal solution for accurately measuring critical vector concentrations. The patent, titled ‘Recombinant adeno-associated virus (rAAV) universal reference standard for determining rAAV genome copy titer by quantitative PCR’, details a significant step toward industry-wide consistency. This innovation, developed by Agathos Biologics , tackles one of the biggest bottlenecks in viral vector manufacturing.
Standardizing Gene Therapy Manufacturing
Accurately dosing and manufacturing gene therapies depends on precisely quantifying recombinant adeno-associated virus (rAAV) vectors. Previously, researchers needed a separate reference standard for every unique rAAV particle they assayed. This new rAAV-Universal Standard vector simplifies the process immensely. It contains multiple common nucleotide sequences. These sequences are targets for quantitative Polymerase Chain Reaction (qPCR) assays. This clever design ensures a positive reaction regardless of the specific transgene being measured. It acts as a reliable calibrator for all rAAV assays.
Ensuring Industry Consistency
The universal reference standard provides manufacturers and regulators with an essential tool. It drastically improves the reliability and comparability of data across different laboratories. Enhanced standardization assures proper performance of quality control assays. This step forward is vital for scaling up clinical trials and commercial production. Ultimately, this technology ensures greater precision and safety in the rapidly expanding field of cell and gene therapy.
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The Research & Experimentation Tax Credit (or R&D Tax Credit), is a general business tax credit under Internal Revenue Code section 41 for companies that incur research and development (R&D) costs in the United States. The credits are a tax incentive for performing qualified research in the United States, resulting in a credit to a tax return. For the first three years of R&D claims, 6% of the total qualified research expenses (QRE) form the gross credit. In the 4th year of claims and beyond, a base amount is calculated, and an adjusted expense line is multiplied times 14%. Click here to learn more.
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