MB Therapeutics receives regulatory clearance for 3D drug printing cartridges

The French National Agency for the Safety of Medicines and Health Products (ANSM) has granted MB Therapeutics authorization to open a pharmaceutical establishment. This regulatory milestone allows the company to manufacture a semi-solid intermediate product packaged in cartridges, which are intended for the 3D printing of personalized solid oral dosage forms.

The company’s platform utilizes two main components: the MED-U Ink cartridge and the MED-U Prod 3D printer. Under this model, the cartridges are manufactured centrally under Good Manufacturing Practices (GMP) to ensure quality and traceability. The actual personalization of the medication—adjusting the exact dose and oral form—occurs at the point of care within hospital pharmacies using the 3D printers.

This approach aims to serve vulnerable populations, such as children and the elderly, who require tailored doses that standard manufacturing cannot easily provide. While the authorization covers the production site and the intermediate cartridge product, the final medicinal products remain subject to existing clinical and formulation regulations.