Enabling Continuous Manufacturing For CAR-T And LNP-Based Therapies: The DIANT Pharma Platform
Next-generation therapies—such as chimeric antigen receptor T-cell (CAR-T) therapies and lipid nanoparticle (LNP)-based drug delivery systems—are reshaping the fields of oncology and genetic medicine. However, broader clinical and commercial adoption is often constrained by complex, batch-based manufacturing approaches that may limit scalability, consistency, and cost-efficiency. In response to these challenges, DIANT Pharma has developed a closed, modular platform designed to support continuous downstream processing. This includes buffer exchange, solvent removal, concentration, and sterile filtration in a streamlined, integrated format. The system is intended for use with both LNP-based nucleic acid delivery and cell-based immunotherapies, such as CAR-T, and incorporates features for real-time process monitoring and potential scalability.
Addressing Manufacturing Challenges in Emerging Modalities
Cell and gene therapies continue to evolve rapidly. CAR-T therapies involve engineering a patient’s own T cells to target cancer, while LNPs are increasingly used as non-viral vectors for delivering nucleic acids, including mRNA, siRNA, and gene-editing materials. While these modalities show clinical promise, their development and broader implementation face hurdles—particularly in manufacturing, where variability, high costs, and labor-intensive procedures are ongoing concerns.
DIANT Pharma’s platform integrates several process steps into a continuous, single-use system. Key features include:
- Jet Mixing for LNP Formation: Designed to support scalable control of lipid self-assembly and particle size during the mixing of lipid and nucleic acid components.
- Single-Pass Tangential Flow Filtration (SPTFF): Enables buffer exchange and concentration in a continuous format, helping reduce shear stress and processing times.
- Integrated Process Analytical Technology (PAT): Real-time sensors monitor flow, pressure, conductivity, and turbidity to enable enhanced process oversight and control.
The closed, modular configuration is designed to reduce manual handling and potential contamination risks while supporting consistent, higher-throughput processing.
Optimizing LNP Purification and Formulation
In nucleic acid delivery, LNPs help protect RNA payloads and facilitate cellular uptake. Following formation via ethanol injection or microfluidic mixing, LNPs typically undergo multiple downstream steps, including:
- Ethanol removal
- Buffer exchange for physiological compatibility
- Concentration for dosing precision
DIANT’s continuous platform is designed to automate and integrate these steps, replacing traditional batch-based operations with a continuous flow approach. This may contribute to improvements in particle size distribution control, encapsulation consistency, and process efficiency, while reducing hands-on intervention.
Supporting Post-Processing for CAR-T Therapies
The CAR-T manufacturing process includes cell isolation, activation, genetic modification, expansion, and final formulation. Downstream steps such as washing, buffer exchange, and final preparation are often performed in open or semi-manual formats, increasing the potential for process variability and contamination.
DIANT Pharma’s system is configured to support:
- Post-expansion buffer exchange and concentration
- Inline closed-loop washing steps via TFF
- Automated sterile filtration and formulation preparation
These capabilities are intended to reduce reliance on manual operations and support more consistent output. As LNPs are also being explored for non-viral T cell engineering, the system’s applicability across both particle and cell processing offers a unified approach to downstream manufacturing.
A Platform Designed for Scalable, Closed, and Monitored Bioprocessing
DIANT Pharma’s continuous manufacturing platform seeks to address key bottlenecks in downstream bioprocessing for both particle- and cell-based therapies. By integrating multiple downstream operations into a closed, single-use, PAT-enabled system, the platform is positioned to support scalable production and more consistent process control. Its modular design and degree of automation are intended to help reduce operational costs, improve reproducibility, and streamline development timeline factors that are increasingly relevant in the context of personalized medicine and genemodified therapies.