The World Health Organization reports that close to 177 million people worldwide currently suffer from diabetes and this figure is expected to more than double by 2030. However, getting new treatments to patients can be complex and time-consuming, especially for small, specialty companies. To expedite the process, Biorep® Technologies, a device manufacturer specializing in tools used in diabetes research and treatment, turned to SABIC Innovative Plastics’ healthcare resin portfolio as it developed a new system for isolating insulin-producing cells faster and more efficiently. Additionally, the firm, based in Miami, Fla. leveraged SABIC Innovative Plastics’ application development assistance to optimize and mass-produce two critical components.
“SABIC Innovative Plastics is committed to helping small, innovative healthcare manufacturers bring their products to market by delivering the services, materials, and expertise that our customers need,” said Mardye Lindway, Ph.D., program manager, Healthcare, SABIC Innovative Plastics. “Through our collaboration with Biorep and the use of our high-performance materials, their groundbreaking system can now be mass-produced, making it more accessible to clinicians and patients.”
Biorep’s technology enables islets – insulin-producing cells from a donor’s pancreas – to be isolated and purified for transplantation in patients whose Type-1 diabetes cannot be controlled with insulin injections. The Ricordi® Chamber, invented by Dr. Camillo Ricordi of the Diabetes Research Institute in Miami, is used to break down the pancreas mechanically and chemically to isolate the islets. The Ricordi Chamber was originally custom-made from stainless steel, which was quite heavy to shake during the 30-45 minute isolation process and prevented doctors from visually assessing the progress of the breaking down of the pancreas.
By injection molding the Ricordi Chamber from Ultem HU polyetherimide (PEI) resin, a translucent, high-temperature, autoclavable material, Biorep achieved several key objectives. According to Ramon Poo, president, Biorep Technologies, “The main benefit of finding a suitable autoclavable plastic is mass production. By using Ultem resin, we can provide chambers to the doctors quickly, instead of the two weeks that it takes to produce a custom stainless steel chamber. The use of Ultem resin to mold chambers also reduces our manufacturing costs. The lower price of the chamber makes it possible for more research centers, universities, and companies to purchase and use the Ricordi Chamber.”
Ultem resin is a rigid, high-strength thermoplastic that can withstand prolonged exposure to high temperatures and repeated sterilization by autoclaving. It has a translucent, light amber color that allows the doctors to see the pancreas inside the chamber. The excellent chemical resistance of Ultem HU resin was also critical, since the enzymes used during the digestion process are extremely caustic.
A disposable perfusion tray, also part of Biorep’s device offering and used in transplant procedures, is injection molded entirely out of SABIC Innovative Plastics’ Cycolac HM acrylonitrile-butadiene-styrene (ABS) resin, which offers excellent toughness, chemical resistance, and bondability. This biocompatible material was custom-colored white using SABIC Innovative Plastics’ ColorXpress service.
SABIC Innovative Plastics adheres to stringent healthcare product requirements covering resin biocompatibility in accordance with either USP Class VI biological or the ISO 10993 “Biological Evaluation of Medical Devices” standards; food contact compliance according to European Union and FDA standards; FDA Drug Master File documentation, and formula lock and rigorous management of the change process.