This summer, CATUG attended the 6th mRNA-Based Therapeutics Summit and the 5th In Vivo Cell Engineering & Gene Editing Summit held concurrently in Boston. Discussions at both conferences clearly shifted toward clinical advancement and scale-up production, with industry focus pivoting from "whether it can be done" to "how to implement it stably and reproducibly."
At the conference, Dr. Mina Li from CATUG's International Affairs Department delivered a presentation titled “Accelerating LNP-Based Pipelines: From Discovery to Clinical Proof-of-Concept and Beyond.” The presentation emphasized that accelerating LNP pipelines cannot rely on single-process optimization alone; it requires integrating plasmid DNA, multi-modal RNA, targeted tLNP, analytical development, and fill-finish into a single industrial closed-loop.
From the early discovery stage, CATUG aligns with FDA and NMPA compliance requirements to minimize late-stage process gaps. The proprietary MaxMix™ system is utilized to enhance consistency during LNP scale-up; a dedicated dsRNA removal process addresses common impurity issues in mRNA production; and the scalable circRNA process and LNP-Antibody targeted conjugation technology have already been applied in projects such as in vivo CAR-T, gene editing, and personalized tumor vaccines.
Discussions on delivery centered around extra-hepatic targeting, immunogenicity control, and repeat administration. Transfection efficiency in solid tumors, the central nervous system (CNS), and T cells remains a major limiting factor for the advancement of in vivo CAR-T. CATUG’s targeted LNP platform can be customized according to project needs, combining partner lipid libraries with antibody and peptide conjugation technologies to support the directional enrichment of tumor and immune cells, while comprehensively addressing endosomal escape, batch-to-batch stability, and scalability. Currently, CATUG’s in vivo CAR-T-related services have covered over 70 clients, encompassing CAR-mRNA/circRNA synthesis, targeted LNP formulation development, and GMP batch production.
CMC (Chemistry, Manufacturing, and Controls) is transitioning from backend R&D support to a core capability spanning the entire project lifecycle. Fluctuations in plasmid fermentation, IVT (in vitro transcription), LNP preparation, or aseptic filling can all impact clinical timelines and risk control.
CATUG implements full-chain pre-planning at the project initiation stage, covering sequence optimization and vector construction, cell/microbial bank establishment, fermentation and purification process development, analytical method validation, and stability studies to reduce the risk of late-stage rework. Dual standardized GMP production facilities in Suzhou and Wuhan cover the production of plasmid, multi-modal RNA, and targeted LNP drug substances, and are equipped with special dosage forms such as lyophilization and inhalation, as well as aseptic fill-finish capabilities, supporting the parallel execution of multiple pipelines. From early development to GMP sample delivery, the fastest turnaround can currently be completed in approximately 5 months.
The platform's unified process and quality system have been validated across different modalities:
circRNA projects: Achieved over 90% purity after one-step circularization, with nicked RNA effectively controlled and single-batch scales exceeding 20 grams.
Antibody-conjugated in vivo CAR-T tLNP projects: PDI controlled below 0.1, encapsulation efficiency exceeding 90%, antibody-to-RNA copy numbers meeting expectations, and single-batch scales exceeding 4 grams.
Personalized tumor vaccine projects: Achieved continuous production from DS to DP, with release completed within one month, and both encapsulation efficiency and purity meeting requirements.
Different technical pathways share the same logic for process development, scale-up, quality control, and rapid release.
As of 2026, CATUG has accumulated over 1,200 delivered projects, serving more than 440 clients—including over 120 overseas clients—with a repeat order rate exceeding 50%. The Suzhou GMP facility successfully passed the EU QP audit in 2025, with production capacity covering milligram to kilogram-scale clinical samples, supporting global mutual recognition of materials and data. The company has business nodes in the United States, Switzerland, and Hong Kong, with R&D and manufacturing functions anchored in Suzhou and Hubei, serving clients across more than 20 countries.
CATUG positions itself as a Biotech-friendly and MNC-trusted CRDMO, maintaining no competing proprietary pipelines, strictly isolating client intellectual property, and integrating DNA, RNA, tLNP, analytics, and GMP fill-finish capabilities into a single platform. This model supports rapid iteration for early-stage teams while meeting the stringent quality system and traceability requirements of multinational corporations.
RNA and in vivo engineering therapies have entered a phase that places greater emphasis on process, quality, and reproducibility. As a technology-driven CRDMO, CATUG will continue to refine its integrated DNA, RNA, LNP, tLNP, and GMP Fill&Finish platform, accelerating the generation of high-quality evidence for global innovation in China and ensuring a smooth transition to subsequent IND filings and global development.