Integrated GMP manufacturing lines from DNA and RNA drug substance to LNP/tLNP and sterile drug product
CATUG’s GMP infrastructure connects upstream drug substance manufacturing, LNP / targeted LNP formulation, sterile fill-finish, lyophilization and CMC documentation under one cross-platform execution framework.
Plasmid DNA GMP Manufacturing
1–500 L GMP Plasmid Lines
Flexible plasmid manufacturing configuration supporting early PCV / IIT projects, IND-enabling GMP raw material, and scale-up needs for RNA, viral vector, gene editing and DNA-based therapeutic programs.
Multiple 1 L PCV / IIT Lines 2 × 3–50 L Single-Use Lines 1 × 20–100 L SS Line 1 × 500 L SS Line Continuous Lysis
RNA Drug Substance GMP Manufacturing
Small-Scale to 20 L IVT Manufacturing
RNA DS manufacturing lines supporting mRNA, circRNA and other RNA modalities from small-scale development and clinical supply to larger GMP batch manufacturing.
Small-Scale IVT Line 2 L IVT 20 L IVT 30 g+ mRNA Proven circRNA GMP
LNP / tLNP GMP Manufacturing
Multi-Platform LNP Encapsulation Capacity
LNP and targeted LNP manufacturing supported by MaxMix-S, PNI GMP, MaxMix-M and MaxMix-L routes, with client-preferred mixing system transfer available through technical evaluation.
MaxMix-S: 0.1–1 L PNI GMP: 0.5–20 L MaxMix-M: 2–30 L MaxMix-L: 20–2000 L Client Mixing Transfer
Sterile Drug Product & Lyophilization
Fill-Finish and Freeze-Dried DP Lines
Sterile filling and lyophilization capabilities supporting RNA-LNP, DNA, small nucleic acid and other advanced therapeutic DP formats.
≤1,000 vials Manual 5,000 vials/batch 100,000 vials/batch 2–10R Lyo Vials