US20260265815
2026-09-10
Chemistry; metallurgy
C12Q1/6848
The patent application details a system designed for automated bioprocessing, specifically targeting the production of nucleic acid therapeutics like mRNA. It integrates multiple processing instruments within a compact support unit, facilitating a complete, closed-loop operation from template amplification to lipid nanoparticle encapsulation. This system employs self-contained cartridges to execute manufacturing sequences autonomously, significantly reducing manual intervention, contamination risk, and labor requirements, while enabling scalable production of personalized therapeutics.
The system addresses the growing demand for personalized nucleic acid therapeutics, which traditional large-scale manufacturing methods struggle to accommodate. Conventional facilities, designed for mass production, face inefficiencies when scaled down for personalized medicine, leading to increased contamination risks and logistical challenges. This invention seeks to overcome these limitations by offering a flexible, automated solution capable of producing small, customized batches without compromising sterility or quality.
The platform comprises three main instruments: a pre-processing instrument for reagent management, a processing instrument for executing nucleic acid manufacturing steps, and a finishing instrument for product extraction and quality control. These components automate the entire bioprocessing workflow, from cartridge preparation to final product packaging. The processing instruments are equipped with real-time monitoring sensors and are designed to maintain a sterile environment, ensuring high-quality output.
The system utilizes self-contained cartridges that house multiple modules for various processing steps, such as amplification and purification. These cartridges are designed to maintain a closed environment, minimizing contamination risks. They feature mechanical, electrical, and fluid interfaces that align with the processing instruments, and may include sensors for monitoring critical parameters. The cartridges are disposable and can be tailored for specific therapeutic formulations, enhancing the system's flexibility.
The method involves loading nucleic acid materials into cartridges and processing them in parallel across multiple instruments, achieving production within 5 to 15 hours. This approach allows for the simultaneous manufacture of different therapeutic products, with real-time feedback provided by sensors. The system supports the creation of patient-specific formulations, maintaining a closed environment throughout the process to prevent contamination, and is capable of meeting both time and scalability demands for custom therapeutics.