CATUG supports clinical-stage and scale-up programs through an integrated GMP platform covering plasmid DNA, RNA drug substance, LNP drug product, sterile fill-finish, lyophilization, QC release, quality documentation, and client IP protection.
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View CATUG’s integrated GMP production, sterile fill-finish, analytical testing and quality-controlled manufacturing operations.
GMP manufacturing, DP filling, lyophilization, QC release and quality documentation are managed under one coordinated system.
~100
GMP personnel across MFG, QA, QC, validation, SCM, engineering and EHS.
100%
External audit pass rate, including EU QP, ISO and client audits.
500+
Quality management documents supporting GMP lifecycle control.
700+
Appendix forms covering controlled records and GMP execution.
CATUG operates an independent quality organization and a GMP quality system aligned with global regulatory expectations. The system covers core FDA cGMP sections and CDMO-specific quality modules for risk management, validation, technology transfer, and computerized systems.
Quality Department operates independently. Key GMP roles including Production Head and Quality Head report directly to senior management, supporting quality oversight and batch decision-making.
Quality system references NMPA GMP, FDA Phase I clinical drug GMP, cGMP Part 210/211, EU GMP Annex 1 / Annex 13, WHO GMP, ICH Q7 / Q10 and PDA TR56.
CATUG has passed EU QP, ISO and client audits, with established GMP release workflows, batch documentation practices, QA review, QC testing and client-facing quality communication.
500+ management documents and 700+ appendix forms support quality records, GMP activities, document lifecycle control, and traceable execution.
CATUG’s GMP platform covers plasmid DNA, RNA drug substance, LNP / targeted LNP drug product, and sterile drug product manufacturing, supporting both integrated RNA-LNP programs and modular GMP work packages.
Plasmid DNA GMP Manufacturing
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.
RNA Drug Substance GMP Manufacturing
RNA DS manufacturing lines supporting mRNA, circRNA and other RNA modalities from small-scale development and clinical supply to larger GMP batch manufacturing.
LNP / tLNP GMP Manufacturing
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.
Sterile Drug Product & Lyophilization
Sterile filling and lyophilization capabilities supporting RNA-LNP, DNA, small nucleic acid and other advanced therapeutic drug product formats.
CATUG’s sterile drug product platform supports integrated RNA-LNP programs and independent fill-finish projects, including sterile filtration, vial filling, visual inspection, labeling, packaging, lyophilization and release support.
Independent DP Service
The fill-finish platform combines manual filling, automatic vial filling, single-use filtration / filling assemblies, isolator-based aseptic processing, visual inspection, labeling, packaging and lyophilization readiness under one quality system.
<1000
vials / batch for manual isolator filling and early-stage compliant sample preparation.
5,000
vials / batch line suitable for IIT to Phase I/II clinical sample supply.
100,000
vials / batch automatic filling capacity for larger clinical supply and scale-up programs.
10M
vials / year sterile liquid filling capacity for the automatic vial filling line.
GMP-compliant manual isolator filling for small-batch and early-stage programs, especially when flexibility, fast iteration, or limited material availability is critical.
Flexible clinical sample supply with approximately 5,000 vials / batch capability, supporting 2–10R vial formats for IIT to Phase I/II programs.
Grade C + isolator automatic filling line, 200 vials / min filling speed, nitrogen filling, sensor monitoring and optional 100% in-line IPC.
Newly launched lyophilization capability with isolator-linked filling, automated loading / unloading, single-use filling system, production-scale lyophilizer, O-RABS design and 2–10R vial support.
Each independent DP project is evaluated based on formulation characteristics, container-closure system, batch size, aseptic processing strategy, release testing requirements, lyophilization feasibility, and cleaning / cross-contamination control.
CATUG manages GMP execution through contamination control strategy, supplier and material management, equipment lifecycle control, laboratory controls, deviation / change / CAPA systems and client-facing quality communication.
Facility, equipment, operation and system controls support aseptic risk management, including APS, CCS, environmental monitoring, personnel qualification and aseptic operation supervision.
Multi-product shared line production is managed through risk assessment, cleaning strategy, cleaning qualification, product-specific critical consumables and residual risk review.
Supplier qualification, on-site audits, qualified supplier list control, material coding, incoming inspection, status labeling and release procedures support material reliability.
Equipment and facilities are managed through procurement, URS, installation, commissioning, validation, calibration, preventive maintenance, change control and lifecycle documentation.
Independent QC laboratory processes cover sample receipt, testing, data review, CoA generation, second-person review, QA review and ALCOA+ data integrity expectations.
Structured deviation, change and CAPA processes support timely client notification, documented investigation, corrective actions, preventive actions and controlled closure.
CATUG is a service-focused CRDMO partner. The operating model is designed to protect client IP, project confidentiality, data boundaries and long-term strategic independence.
All ownership and intellectual property rights to client-derived project outputs belong solely and entirely to the client. CATUG can support project-specific NDAs, core personnel exclusivity, non-compete clauses and project technical-secret exclusivity agreements.
Centralized device and account management, one-account-per-person control, standard user privileges and IT-managed administrator rights.
Office and PDF files can be classified as Internal, Public, Confidential or Restricted, with watermarking, permissions and dissemination controls.
USB transfers, WeChat file sending, external cloud storage and external email clients can be restricted, with audit trails linked to DLP labels.
Office networks cannot directly access R&D and production networks. Business access is routed through controlled platforms to support production network security.
Local private cloud infrastructure, clustered deployment, daily snapshots and backup / recovery support help keep critical business data inside CATUG.
Projects are assigned classification numbers from initiation, helping obscure client and project names and supporting hierarchical information management.
CATUG can help evaluate GMP manufacturing readiness, independent sterile filling, lyophilization feasibility, release testing, quality documentation, and IP protection needs for nucleic acid therapeutics and compatible sterile injectable programs.