Interview with Martial Sauceau, Assistant Professor at IMT Mines Albi, teacher in the Master Advanced Pharmaceutical Engineering (AdPharming) and researcher in the RAPSODEE joint research center with the CNRS. He is working on the development of new processes for the manufacturing of drugs, using in particular supercritical fluids and 3D printing.
 

The first 3D printed drug

3D printing has developed in many industries over the last 20 years, but the first 3D printed drug approved by the Food and Drug Administration (FDA) in 2015 was a prescription drug used in the treatment of epilepsy. FDA approval provided validation of this type of process by the regulatory authorities, which is essential in the drug field.
 

The benefits and challenges of 3D printing of drugs

In fact, the physical and chemical phenomena are the same as before, it is the way in which the object is produced (layer by layer) that changes. There are three main advantages.

• Ease of customization and personalization

Martial SAUCEAU, par jfages

With 3D printing, it is now possible to make increasingly complex shaped objects that are not always possible with other conventional processes. For example, shapes that are more attractive or better adapted to the needs of the elderly or children.

Moreover, the pharmaceutical industry is very interested in personalized medicine. In absolute terms, each individual may need their own particular drug according to their characteristics. For example, in the Pediatrics departments of some hospitals, customized drugs are already being produced. If the medication has proven to be effective, and if the benefit is considered to outweigh the risk, the medication approved by the regulatory authorities is adapted outside the scope of any “written rules”. Hence medical professionals are very interested in having new methods to produce even more effective, customized drugs than the ones they already have.

• Manufacture on demand

Another advantage of 3D printing is that it enables manufacture on demand. Faced with the Covid crisis, people all over the world managed to produce things on site, locally and very quickly at home. One day, perhaps drugs will be manufactured in this way. Rather than being produced in a centralized manner in large factories, they could be manufactured in many different places such as at pharmacies, in difficult to access locations, crisis situations, or even at home, and above all only when the drugs are needed. For example, if a drug does not keep well, the ingredients could be transported under the proper conditions to the place that it is to be given, and the drug could be manufactured at the last moment. This could revolutionize the entire drug supply chain.

• Rapid prototyping 

Another very important advantage for drug manufacturing is prototyping. Thanks to 3D printing it is now possible to manufacture objects very quickly, even very complex ones containing several active ingredients or in very particular shapes. With a 3D printer, only a few hours are needed to produce the desired object in small quantities. This provides enormous flexibility. Moreover today it is unthinkable to have an innovation hub without a 3D printer.

Legal issues and 3D

Currently, drugs already incorporate protected high technologies. In this respect, 3D printing is not going to change everything. What is likely to change completely is the entire chain. Today, a pharmaceutical company that sells a drug is responsible for it until it is taken. The drug is sold to be consumed as is. In the future pharmaceutical industries may only sell the active ingredient, which would then be shaped by someone else. This is likely to completely change the way that the entire drug manufacturing and supply chain is designed and the associated liabilities. Furthermore, this could be a potential source of risk for patients. Liability and IP issues still need to be resolved.

Limited to small batches

One of the limitations of 3D printing is that is not expected to be used to produce drugs in large batches any time soon. Typically, paracetamol will remain a product manufactured with conventional processes. 3D printing will be used to produce small batches of high added value personalized drugs. Most 3D technologies effectively remain slower than certain more conventional, successfully industrialized processes. However, it should be noted that today the situation and technologies are fast evolving.