CATUG Biotechnology has surpassed 300 cumulative GMP production batches. The batches span plasmid DNA, RNA drug substance, LNP formulation, tLNP conjugates and aseptic filling. Projects cover a range of modalities and formulations, including mRNA, circRNA, mRNA/gRNA combinations and multivalent co-encapsulation.

Two sites, tiered capacity

As RNA programs move from early research into the clinic, their needs for production scale, process conditions and formulation change. To meet those needs at each stage, CATUG runs GMP manufacturing sites in Suzhou and Wuhan. Together they cover plasmid DNA, RNA drug substance, LNP formulation, aseptic filling and lyophilization.

The Suzhou site was designed for clinical through commercial manufacturing. It houses plasmid DNA, RNA drug substance, (t)LNP formulation, aseptic filling and quality control. Its automated aseptic filling line handles up to about 100,000 vials per batch. A separate hundred-milligram-scale IVT+LNP rapid-response line supplies early clinical material and also supports larger clinical runs. The RNA-LNP lyophilization line is in operation, and the lyophilization process has been scaled up and validated.

The Wuhan site focuses on small-batch, flexible production for IIT, IND and early clinical programs. It has a nanobody line for VHH production by 5–100 L microbial fermentation, and its fully automated aseptic filling line handles up to about 5,000 vials per batch.

CATUG's RNA production scale ranges from mg to 100 g. In representative completed batches, mRNA output exceeded 45 g per batch, and mRNA-LNP and circRNA output each exceeded 20 g per batch.

GMP manufacturing strengths

01 Phase III and commercial manufacturing

In Suzhou, plasmid DNA, RNA drug substance, (t)LNP formulation, aseptic filling and quality control all run on one campus. This cuts transfers of intermediates between sites and quality handoffs between parties. Because scale-up at every step happens within a single quality system, consistency from batch to batch is easier to maintain.

On the drug product side, CATUG offers both liquid and lyophilized formulations, each in 2–10R vials. Clients choose the dosage form based on formulation, stability targets and intended use, and CATUG carries out the matching process development and manufacturing.

02 PCV: personalized production and fast turnaround

Personalized cancer vaccine (PCV) programs depend on fast delivery. The Suzhou site has a dedicated PCV suite, with a target cycle of 4–7 weeks from sequence design to mRNA release. Multiple IIT batches have been completed.

03 End-to-end in vivo CAR manufacturing

In in vivo CAR programs, targeted delivery is critical. Quality attributes of the tLNP affect in vivo transfection, including antibody conjugation efficiency, ligand density, particle size and encapsulation efficiency. CATUG has built end-to-end capabilities that cover payload design, plasmid DNA and RNA production, LNP preparation, VHH nanobody production, LNP-antibody conjugation, analytical characterization and release, and GMP manufacturing. The company has delivered GMP material for multiple in vivo CAR-T clinical programs.

Note: Figures above are representative historical production records, not guaranteed yields for every sequence or process condition. Actual production specifications depend on project assessment and process confirmation.

On the regulatory side, CATUG's Suzhou GMP facility passed an EU QP on-site audit in 2025, giving overseas programs a quality-system basis for clinical manufacturing. As of Q3 2026, CATUG has served more than 470 clients, over 140 of them outside China, and has delivered more than 1,200 orders to clients in more than 25 countries and regions.

Dr. Keyun Ren, Co-founder and General Manager of CATUG, said the 300-batch milestone came from the team and its clients advancing projects together. RNA drugs involve different modalities, process routes and formulation requirements, and every project has its own manufacturing conditions and quality standards. As programs move into later-stage trials, they bring new demands on scale, process scale-up and formulation choice. "We will keep building on what we learn from these projects, refining our facilities and process setup, and supporting clients at every stage of development," he said.

Next, CATUG will keep developing its end-to-end DNA–RNA–(t)LNP manufacturing platform, build out lyophilized formulation and late-stage clinical capacity, and expand its services for overseas programs.