Phillips-Medisize, a Molex company, announced today an agreement with a leading biotechnology company to manufacture a wearable, electronic-enabled combination product. The product is a post-phase III development-stage combination drug and device that combines two-day, single use, disposable technology for subcutaneous drug delivery.
The wearable combination product - which is replaced every two days - is about the size of a hockey puck, and can either be adhered to the patient's body, via an adhesive patch, or worn near the infusion site.
Phillips-Medisize, which built devices and supplied key data to support the FDA NDA submission, will provide final assembly, testing and quality control of this electronic combination product. Specifically, Phillips-Medisize will handle the prefilled drug cartridge that fits inside the device. This drug container is aseptically filled and shipped to Phillips-Medisize. Several state-of-the-art Phillips-Medisize facilities are involved in various stages of manufacturing the combination product - including molding, assembly, drug handling, labeling, reconciliation and more.
"This exciting new contract taps over 13 years of Phillips-Medisize's combination product expertise, which includes cold chain drug handling and first programs with API handling. We have experience in manufacturing both combination and electronic-enabled drug delivery devices, and this is our first product submitted for FDA approval that includes both," said Matt Jennings, CEO and President, Phillips-Medisize.
Pending receipt of FDA approval, Phillips-Medisize is contracted to provide commercialization services from its Hudson, WI-based manufacturing site. The combination product is slated for launch in 2H 2020. Backed by Phillips-Medisize's scalability to move to high volume production, the product will be well positioned for a successful market launch.
Strong potential also exists to bring the device onto a connected health platform in the future, by embedding low-cost connectivity that will make it possible to capture and communicate data between patient and provider in order to help monitor adherence.