3D Drug Printing Gets FDA Go Ahead

Sat, 09/05/2015 - 12:27

Scientists have been developing 3D printing technologies for almost 30 years but only recently has the technology come to the forefront of the medical and pharmaceutical industries, raising the potential to deliver drugs in a personalized format that could revolutionize the sector. In August 2015 the FDA approved the first ever 3D printed drug for consumer consumption. Spritam, an epilepsy treatment, will be produced by US pharmaceutical Aprecia and will, according to the company, “transform the way patients experience taking medication.”

In 2013, researchers from the University of Illinois, the Institute of Genomic Biology and the University of Michigan worked in collaboration to 3D print an artificial trachea for an infant with the rare tracheobronchomalacia, which causes the windpipe to continually collapse. The process was carried out using a 3D scan of a pig trachea and the FDA approved material polycaprolactone (PCL). Since the surgery, the baby’s trachea has completely regenerated and the PCL is expected to degrade naturally in the patient’s system, causing no long lasting side effects. In the same year, Organovo successfully printed a human liver using 3D bioprinting techniques.

Since then, within the pharma industry in particular, it has been found that 3D printing can actually overhaul and improve the administration of drugs due to its capabilities. Researchers at the University College of London School of Pharmacy have been able to print different shapes of drugs using a technique known as “hot melt extrusion.” This is relevant as convincing findings have revealed that the shape of a drug considerably impacts its effectiveness. For  example, the shape of the drug can determine how fast the medication is released, which may be a particular benefit in the administration of certain products including blood thinners and immunosuppressants. The traditional process of manufacturing drugs, however, does not have the same capability of producing them in the same complex shapes as 3D printing methods.

The 3D printing industry in 2012 was valued at US$2.2 billion but this should more than double to US$5.2 billion by 2020. In Latin America, the process is evolving equally quickly. In Mexico, a doctor used 3D printing techniques to create skin. Carlos Ramirez, Director of the Mexico, Central America and Caribbean division of 3D printing company STRATASYS, believes that the technology is becoming more and more accessible and widely used. Javier Cruz, Engineering Director of 3D Insoft believes that, in the next two years, 3D printing will become a massive industry within the medical sector. He cites the more affordable cost in recent years, claiming that 3D printing procedures which would previously have cost up US$30,000 can today be as cheap as US$500.

Despite the now established uses of 3D printing for devices, for the first time 3D printed drugs are being made available to consumers, and it remains to be seen how this will impact the industry. Chris Rivera, President and CEO of the Washington Biotechnology and Biomedical Association, believes that if 3D printing is able to adopt an effective business strategy, the result could be a drop in profits for traditional pharmaceutical production. On the other hand, he sees this as a unique opportunity for innovation if the sector can collaborate with scientists to integrate the techniques into marketing strategies. The prospect of personalized medicine brought directly to the home of the consumer is sure to be one of the biggest game- changers in recent years