Advanced process analytical technologies for continuous mrna-lnp manufacturing
DIANT Pharma Inc introduces cutting-edge process analytical technologies (PATs) for continuous manufacturing of mRNA-loaded lipid nanoparticles (LNPs). This system enhances control over nanoparticle formation and distribution, ensuring higher stability and yield.
Overview
DIANT Pharma Inc presents an innovative solution for the continuous manufacturing of mRNA-loaded lipid nanoparticles (mRNA-LNPs), addressing the challenges posed by traditional batch processes. Our advanced process analytical technologies (PATs) offer real-time monitoring and feedback, significantly improving the control over nanoparticle formation, size distribution, and stability. This robust system is designed to optimize the manufacturing process, resulting in higher yield and throughput with precise particle morphology.
Technical specifications
Our solution integrates cutting-edge inline and online PATs with sophisticated data management systems. Key features include:
- Real-time analytical data collection for immediate process adjustments
- Enhanced control over nanoparticle formation, ensuring tight particle size distribution
- Compatibility with a variety of particle types, including LNPs, liposomal, and polymeric nanoparticles
- Proven efficiency in processing activities, demonstrated in our service laboratory with various products, such as Doxil
Technology readiness level
The technology has achieved a Technology Readiness Level (TRL) of 4, indicating that it has been validated in a laboratory environment. Our systems are currently under review by the FDA, highlighting their potential for large-scale manufacturing adoption.
About DIANT Pharma Inc
DIANT Pharma Inc. is a biopharmaceutical solutions company that specializes in the development of continuous, end-to-end manufacturing platforms for nanoparticles and lipid nanoparticles (LNPs). Founded in 2019, the company developed the proprietary DIANT Jet technology, an automated system designed to integrate nanoparticle generation with downstream operations in a closed-loop environment. By enabling precise, inline control of particle size and characteristics, this technology aims to replace traditional batch manufacturing with a more efficient, scalable, and reproducible process for the production of nucleic acid therapies, including mRNA vaccines and other advanced nanomedicines.
DIANT provides its proprietary equipment, services, and consulting to partners in the pharmaceutical, nutraceutical, and cosmetic industries, helping them de-risk and accelerate the path from research and development to commercial manufacturing. The company's platforms are built to reduce production footprints and minimize human intervention while ensuring high-quality, uniform particle formulations. DIANT’s commitment to advanced manufacturing is evidenced by its engagement with regulatory bodies, including the U.S. Food & Drug Administration, which has acquired DIANT systems for internal research, and its participation in federal innovation programs. Through these efforts, DIANT supports CDMOs and innovators in optimizing their formulation processes and improving the speed to market for complex therapeutics.
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