Follow the path from mRNA encapsulation to mRNA drug product distribution
FORMULATE AND ENCAPSULATE mRNAPurified mRNA is combined with lipids and/or polymers to encapsulate the mRNA for efficient delivery and stability.
mRNA - LNP purificationResulting lipid nanoparticle (LNP) – mRNA complexes undergo TFF and diafiltration to remove any residual process contaminants and ensure sterility of the final product.
STERILE FILL AND FINISHPurified drug product is filled into primary product containers, capped, sealed and lyophilized (if appropriate), all while maintaining sterility.
PRIMARY LABELLINGPrimary product are labelled to ensure to ensure product traceability and compliance.
COLD CHAIN LOGISTICSLabelled product is placed into secondary packaging containers to ensure quality and integrity throughout storage and distribution.
TEMPERATURE-CONTROLLED STORAGEIt is critical to properly maintain chain of custody and temperature requirements of the drug product during storage
TEMPERATURE-CONTROLLED DISTRIBUTIONMaintenance of chain of custody and temperature requirements during distribution is equally important to ensure that the drug product arrives on time, in full and at correct temperature
