[Suzhou, China | April 2026] —CATUG has officially launched its RNA-LNP lyophilization manufacturing line. The new facility is designed to deliver stable, efficient, and flexible industrial-scale solutions for RNA therapeutics, further strengthening the company’s end-to-end formulation capabilities.
Engineering Excellence — Enabling Reliable Delivery
The newly commissioned line features high-grade aseptic control and integrated automation. Through systematic engineering design and the use of advanced domestic equipment, it ensures process consistency and long-term operational stability.
Key setup includes an isolator-based filling line, automated loading/unloading lyophilization system, and single-use filling systems, supporting 2–10R vial formats. Core equipment includes a Tofflon production-scale lyophilizer integrated with isolator filling and O-RABS design, meeting GMP-compliant aseptic standards.
Process control is enhanced with CIP-enabled tunnel ovens, SIP cooling sections, 100% in-process weight checks (IPC), and wireless temperature probes for real-time monitoring and full data traceability. The adoption of domestic high-end equipment also improves supply chain responsiveness and reduces lead times.
The line is designed for both early-stage agility and late-stage scale-up, minimizing tech transfer risks and ensuring seamless transition from lab-scale to commercial production.
Capacity Matrix — Expanding Application Scenarios
Liquid RNA-LNP formulations rely heavily on ultra-cold storage, increasing logistics complexity and limiting accessibility. CATUG addresses this challenge through optimized lyophilization processes, converting liquid formulations into more stable solid forms.
The resulting lyophilized products form well-structured cakes with rapid reconstitution and clear solutions, maintaining stability at 2–8°C or even 25°C. This significantly reduces cold-chain dependency and supports broader applications such as vaccines, emergency therapeutics, and global distribution programs.
In addition to the new lyophilization line, CATUG has established a comprehensive filling capacity network across Suzhou and Wuhan:
These lines operate under a unified quality system, enabling seamless project progression and scalable capacity upgrades. Services extend beyond mRNA-LNP to DNA and other nucleic acid therapeutics.
Quality Control — End-to-End Assurance System
CATUG has established a full GMP quality and release system covering liquid and lyophilized formulations from early-stage to commercial scale. Standardized QC metrics include particle size, PDI, encapsulation efficiency, nucleic acid integrity and purity, endotoxin levels, and in vitro bioactivity.
For lyophilized products, additional controls such as residual moisture, reconstitution performance, and cake structure are implemented. Optimized lyophilization cycles and excipient systems protect RNA-LNP integrity and bioactivity, minimizing changes in particle size and encapsulation efficiency post-reconstitution, while ensuring batch consistency and full traceability.
Leadership Perspective
Dr. Keyun Ren, General Manager of CATUG, commented:
“As RNA therapeutics move toward large-scale commercialization, formulation engineering becomes a key determinant of success. The launch of this lyophilization line reduces reliance on ultra-cold logistics and significantly improves accessibility.”
“By integrating engineering design, formulation optimization, and high-standard quality systems, we are building a forward-looking RNA manufacturing platform—enabling our partners to bring innovative therapies to clinic and market more efficiently and reliably.”