Israeli company has opened a new manufacturing facility with a 80 sqm ISO Class 7 cleanroom facilities to accommodate manufacturing scalability of its wearable drug delivery devices
Sorrel Medical, a developer and manufacturer of wearable drug delivery devices, has opened a new manufacturing facility with state-of-the-art cleanroom facilities to accommodate manufacturing scalability of its wearable drug delivery devices.
The new facility will enable Sorrel Medical's transition from initial design and development, with low-volume manufacturing, to scalable high-quality production of wearable drug delivery devices to meet the needs of numerous global pharmaceutical partner programs, as Sorrel Medical prepares for upcoming clinical trials and commercial supply. The new facility, including an 80 sqm cleanroom, will enable Sorrel to increase initial production capacity to hundreds of thousands of units per year.
"As Sorrel continues to grow, this new facility will enable us to support global pharmaceutical and biotechnology partners to bring next-generation drug delivery solutions to patients," said Bentsi Algazi, Vice President of Operations at Sorrel. "These enhanced production scale-up capabilities will enable us to positively impact countless patients living with chronic and high burden conditions."
The production cleanroom is an ISO class 7 environment, specifically intended to reduce particulate contamination in accordance with ISO 14664-1:2015 and EU GMP Annex 1 requirements, as well as controlling 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.
Sorrel's platform of pre-filled and pre-loaded wearable drug delivery devices facilitates the simple and efficient self-administration of large volume and high viscosity medications. The versatile and fully connected on-body injectors are specifically designed to enhance the patient experience and encourage adherence to treatment therapies, while supporting pharmaceutical partners in bringing combination products to market. Key features include a 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.