Sorrel Medical, a firm that specializes in developing wearable drug delivery devices, has opened a new manufacturing facility in Israel. The plant will enable the company to transition from initial design and development and low-volume manufacturing, to scalable high-quality production of such devices.
The facility’s features include an 80-square-meter cleanroom. Production at the facility will be geared toward serving the clinical trial industry as well as commercial use.
Andrei Yosef, Sorrel Medical CEO, told Outsourcing-Pharma that the new facility will enable the company to better serve clinical research professionals and meet its high quality standards.
“Enabling manufacturing in-house allows Sorrel to maintain better control and ensure the highest quality that is required for ISO 7 clean room device manufacturing,” he said. “In addition, when transferring a development project from R&D to operations, proximity of the Sorrel offices to the clean room manufacturing site proves to be imperative and allows for quick resolution of any issues that arise.”
Bentsi Algazi, vice president of operations for Sorrel Medical, said the addition of the new facility empowers the company to accommodate future growth as well as technological advancements.
“This new facility will enable us to support global pharmaceutical and biotechnology partners to bring next-generation drug delivery solutions to patients," he said. "These enhanced production scale-up capabilities will enable us to positively impact countless patients living with chronic and high burden conditions."
The wearables produced by the company will meet the varied needs of clinical research professionals, Yosef said.
“Sorrel’s wearable injectors enable clinical trials in the homecare settings for large volume and high viscosity medications,” Yosef told us. “Our devices were designed for easy and intuitive self-administration experience, accommodating a wide range of patient populations. In addition, NFC and Bluetooth connectivity enable easy tracking and logging of all self-administration data in a seamless and reliable method.”
Other features of the company’s devices include primary container-agnostic configuration to accommodate a variety of industry standard primary drug containers, UV LED disinfection, and smart sensing capabilities to ensure successful administration.
The production cleanroom is an ISO class 7 environment, intended to reduce particulate contamination in accordance with ISO 14664-1:2015 and EU GMP Annex 1 requirement; it also maintains a high degree of control for other environmental parameters such as temperature, humidity and pressure. Additional features of the new facility include an IQC lab, washing room, gowning room and warehouse.