The French National Agency for the Safety of Medicines and Health Products (ANSM) has granted French company MB Therapeutics the authorization to open a pharmaceutical establishment. This means the start-up can now manufacture a semi-solid intermediate product, packaged in cartridges, for the 3D printing of solid oral dosage forms.
Although the company claims it is first to achieve this milestone, it should be noted that Finland’s CurifyLabs, already supplies GMP-manufactured excipient bases that pharmacists combine with the active ingredient.
Standardizing the cartridge to personalize the dose
The use of standardized doses for drug production does not meet the needs of vulnerable populations such as children and elderly patients, who often need tailored doses and oral forms that are easier to take. With MB Therapeutics’ approach, the patented cartridge becomes the standardized pharmaceutical product, manufactured under Good Manufacturing Practices (GMP).
Personalization happens later, at the point of care: the company’s 3D printers, designed for hospital pharmacies, use these cartridges to produce oral forms at the exact dose each patient needs. The company says the model ensures quality and traceability from cartridge production through to printing.
The ANSM authorization confirms that MB Therapeutics’ file, including its quality system and infrastructure, met the requirements to apply for a pharmaceutical manufacturing site.
“Beyond precise dose adjustment and rapid availability in the pharmacy, 3D printing makes it possible to offer adapted dosage forms, such as personalized dispersible and orodispersible forms,” says Dr Manon Perez, pharmacist and Quality Director at MB Therapeutics.
That said, regulatory clearance is one hurdle while market access is another one. As we explored in our dossier on reimbursement pathways for 3D printing in Europe, the technology is often ready before the system is.
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