Table 2.

Proposed QTPP for non-viral vectors for genetic material delivery.

Element	Target	Justification
Administration route	Intravenous	To improve the efficacy and bioavailability; direct availability in the bloodstream
Dosage form	Injection	Low volume production allows customisation to client/quantities
Delivery system element	Non-viral vector	Provides safer and more effective delivery of the genetic material
pH	7.35–7.45	To prevent or reduce vascular complications
Osmolarity	290–310 mOsm/L	To ensure tolerability
Particle size	Below 200 nm	To ensure penetration in the cell
Homogeneity	Monodisperse	To ensure system’s homogeneity
Enhanced therapeutic activity	High transfection efficiency (over 80%)	To improve system’s effectiveness
Storage condition	−60 °C ± 20 °C	To guarantee the stability of the genetic material
Improved safety	Lack of cytotoxicity, lack of haemolytic activity	To ensure appropriate biological requirements
Microbiological quality	Sterile and pyrogen-free	To avoid contamination with microorganisms; to ensure patient safety
In vitro release	Prolonged release	To ensure release according to a predefined release pattern, or to ensure spatio-temporal release of the payload