Plastics Machinery Manufacturer Advances Forward

On April 16-17, 2013, Medical Plastics News attended a joint open house between the European arm of Milacron’s extrusion machinery brand, Cincinnati Milacron, and Ferromatik Milacron, the UK subsidiary of Milacron’s European injection moulding machinery manufacturing outfit. The event housed a demonstration of a medical single lumen catheter tubing extrusion line at a joint open house event in Chesterfield, UK, in April 2013.

Medical injection moulding machinery was also on show at the event. The dedicated public demonstration of medical extrusion and injection moulding under one roof has been confirmed as a European first by Tim Appels of Dutch medical catheter manufacturing equipment supplier 2Spring.

The event follows an announcement in mid February 2013 that Milacron had acquired US hot runner technology manufacturer Mold Masters for US$975 mn.

In November 2012, the company appointed a new sales and marketing VP, Shawn Reilly. Shawn was previously president of one of the USA’s largest pharmaceutical packaging manufacturers AndersonBrecon.

At the time of Shawn Reilly’s appointment, Medical Plastics News asked him to describe the most exciting trend he had witnessed. Shawn responded without hesitation. The topic was biopharmaceuticals.

Biopharmaceutical drugs are medical drugs which have been produced using biotechnology. According to Wikipedia, biotechnology—or biotech—is the use of living systems and organisms to develop or make useful products. The UN Convention on Biological Diversity defines biotechnology as “any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products or processes for specific use”.

Wikipedia explains the difference between traditional and biopharmaceutical drugs. Most traditional pharmaceutical drugs are composed of relatively small molecules that bind to particular molecular targets and either activate or deactivate biological processes. Small molecules are typically manufactured through traditional organic synthesis, and many can be taken orally.

In contrast, biopharmaceutical drugs consist of large biological molecules, such as proteins, which are developed to address targets that small molecules cannot easily handle. Some examples of biopharmaceutical drugs include Infliximab, a monoclonal antibody used in the treatment of autoimmune diseases, Etanercept, a fusion protein used in the treatment of autoimmune diseases, and Rituximab, a chimeric monoclonal antibody used in the treatment of cancer. Due to their larger molecule size, and corresponding difficulty with surviving the stomach, colon and liver, biopharmaceuticals are typically injected.

Modern biotechnology is often associated with the use of genetically altered microorganisms such as E coli or yeast for the production of substances like synthetic insulin or antibiotics. It can also refer to transgenic animals or transgenic plants, such as Bt corn. Genetically altered mammalian cells, such as Chinese hamster ovary cells, are also used to manufacture certain pharmaceuticals. Another promising new biotechnology application is the development of plant-made pharmaceuticals.

Plastics, thanks to their versatility in design, inertness and low cost, are becoming the material of choice for manufacturers of biopharmaceutical drug delivery devices.

In terms of delivery devices, many of the most advanced biopharmaceutical drugs require some exacting demands. Often, delivery devices must be highly accurate in terms of dosge.

Shawn Reilly explains: “Medical device delivery systems which meet the requirements of some of the newest large molecule biopharmaceutical drugs requires sophistication in injection moulding, assembly and packaging. This presents a significant opportunity for medical plastics manufacturers to meet a growing need.”

To give a flavour of just how sophisticated drug delivery device design and manufacturing can be, Shawn quoted some examples: “Potent, highly toxic compounds like those used in oncology are delivered in units of 10-4 mg and therefore need highly accurate delivery.”

“For self-treatments of chronic diseases, the device must be designed so that the chance of mis-dosing is minimised as far as possible. To achieve this and more, drug delivery devices consist of four or five components while maintaining complete integrity.”

It can take up to 15 years to develop a new medicine. The design and development of the delivery mechanism can start as many as six or seven years before the expected approval date.

Medical Plastics News forecasts that as the plastics industry’s understanding of materials and mould design develops, the delivery mechanism will play a bigger and more crucial role in drug development.