Emerging Delivery Development
Practical CMC support for RNA delivery systems outside standard LNP routes
For emerging RNA delivery systems, the core challenge is often not a fixed formulation recipe, but the ability to understand payload behavior, carrier-material compatibility, mixing process, route-specific stability, analytical requirements, manufacturability and transfer feasibility. CATUG supports these programs through collaborative formulation development, process optimization and CMC-oriented execution.
Polymer-Based Systems
Polymer-Enabled RNA Formulations
Support for polymer-based or polyplex-type RNA formulation exploration, payload incorporation, complex formation, formulation robustness and early developability assessment.
Pulmonary Delivery
Inhalation / Nebulization-Oriented Development
Relevant project experience involving aerosol-oriented RNA delivery, where nebulization compatibility, shear sensitivity, particle stability and RNA integrity are critical development considerations.
Alternative Lipid Chemistry
Cationic-Lipid-Replaced Delivery Designs
Technical collaboration for systems where conventional cationic or ionizable lipid components are reduced, replaced or redesigned, requiring case-specific formulation and process evaluation.
Surface Component Optimization
PEG-Lipid / Surface Chemistry Tuning
Support for client-originated optimization of PEG-lipid, surface components, shielding strategy, colloidal stability and delivery-relevant formulation attributes.
Process Development
Complex Formulation Process Evaluation
Development support can include material screening, mixing strategy evaluation, process parameter tuning, hold-time assessment, filtration feasibility and scale-up-oriented process understanding.
Tech Transfer Collaboration
Client-Originated System Transfer
For client-provided or partner-originated delivery systems, CATUG can support technical evaluation, process transfer, comparability planning and CMC execution aligned with the client’s preferred platform.