CATUG offers an integrated CRDMO platform that consolidates plasmid DNA, mRNA/saRNA/circRNA production, and lipid/polymer delivery system formulation with GMP‑compliant manufacturing and CMC support. Its proprietary continuous lysis, MaxMix™ mixing, and multi‑payload technologies enable high‑purity, scalable manufacturing and flexible delivery options for nucleic acid‑based therapeutics, accelerating IND filing and clinical supply for biotech and pharma developers.
Funding
Funding not disclosed
Founders
Product
Problem
Biopharmaceutical developers often face fragmented supply chains for nucleic acid‑based therapeutics, requiring separate vendors for plasmid DNA, RNA drug substance, delivery vehicles, and GMP manufacturing, which leads to delays, inconsistent quality, and regulatory complexity.
Solution
CATUG provides an integrated CRDMO platform that consolidates plasmid DNA, mRNA/saRNA/circRNA production, lipid and polymer delivery system formulation, and GMP‑compliant manufacturing under a single quality system. The company offers modular or end‑to‑end services, from sequence design and process development to scale‑up, fill‑finish, lyophilization, and CMC documentation. Proprietary technologies such as continuous lysis for plasmid production, MaxMix™ scalable mixing for LNP/tLNP encapsulation, and multi‑payload formulation enable high recovery, low polydispersity, and flexible payload combinations. All services are supported by a GMP‑ready facility with validated analytical methods and regulatory‑aligned quality controls, allowing clients to accelerate IND filing and clinical supply while protecting IP.
Target Audience
Biotech and pharmaceutical companies developing nucleic acid‑based therapeutics, gene‑editing programs, RNA vaccines, and advanced protein or peptide modalities that require integrated manufacturing and CMC services.
Features
- Continuous lysis system for high‑yield plasmid DNA manufacturing with ≥95% supercoiled purity
- Flexible plasmid GMP lines (1 L–500 L) supporting raw material, IVT templates, and DNA drug products
- Integrated IVT platform for mRNA, self‑amplifying RNA, and circular RNA with enzymatic or co‑transcriptional capping options
- MaxMix™ and microfluidic (PNI) mixing platforms delivering scalable LNP/tLNP production (0.1 L–2 000 L) with high encapsulation efficiency (>97%) and low PDI
- Library of 1,000+ novel lipids and polymer delivery systems, enabling targeted LNP conjugation (antibody, peptide, aptamer) for in‑vivo CAR and cell‑specific delivery
- GMP‑qualified sterile fill‑finish and lyophilization lines supporting up to 100 000 vials per batch and 10 M vials per year
- Comprehensive CMC support including analytical method development, regulatory documentation, and IP protection across all modalities