Inverted Terminal Repeats (ITRs) are DNA sequences flanking the transgene of interest to signal incorporation into adeno-associated virus (AAV) or genome insertion by transposases. Despite sharing the ITR element name, viral vector and transposon ITRs differ in sequence and important properties that need to be considered in handling these vectors.
The manufacture and release of mRNA therapeutics and vaccines is a complex and challenging process requiring a high degree of expertise, capabilities, and experience. The development and manufacturing of final drug product involves several stages that include production of cell banks, linear DNA, and mRNA drug substance, with lipid nanoparticle (LNP) formulation/encapsulation and analytical testing at all steps, through aseptic fill/finish.
