Innovation Within Drug Development: 3D Printing Of Pharmaceutical Dosage Forms – Has The Time Come?

By Dr. Asma Patel, Vice President of Integrated Development Services, Quotient Sciences

We work in a dynamic and innovative industry, which is constantly seeking new ways to do things better in order to accelerate the availability of new medicines for patients. However, the approach towards Good Manufacturing Practice (GMP) manufacturing of pharmaceutical dosage forms for clinical and commercial use has largely remained unchanged over several decades, with a focus on batch processing at large scale, often requiring complex equipment trains.

In recent years, we have started to see a shift in the types of new therapeutics reaching the marketplace. More than half of new US Food and Drug Administration (FDA) drug approvals since 2018 have been for rare diseases, which are defined as affecting less than 200,000 people in the US or no more than one in 2,000 of the general EU population. There will need to be a greater emphasis on small-scale, flexible manufacturing to address this demand, where product supply is fully tuned to the size and shape of these emerging patient populations.

Additive manufacturing (also known as 3D printing) is now commonplace in many industries. However, for pharmaceuticals, it is still nascent and arguably balancing on the cusp of translation from academic research into industry practice. What will the future impact of 3D printing be, given the changing dynamics in clinical research?