— Submission represents an important step towards establishing the Cellbox Live Shipment Technology as a new standard for warm chain logistic in the cell therapy sector
— Cellbox customers can now reference the DMF, simplifying and accelerating their regulatory approval process for cell therapy production processes involving the Cellbox Technology
Hamburg, Germany, September 25, 2023 – Cellbox Solutions GmbH, a leading provider of warm chain logistics solutions for the research, development and shipment of cell-based therapies and cellular diagnostics, today announced that is has successfully submitted a Device Master File (DMF) for its Cellbox Live Shipment Technology to the U.S. Food and Drug Administration’s (FDA). The DMF is a detailed dossier submitted to the FDA which contains confidential and proprietary information regarding specifications of the Cellbox technology.
Prof. Dr. Kathrin Adlkofer, Founder of Cellbox Solutions commented: “The submission of the Device Master File to the U.S. FDA is an important milestone for us in the implementation of our global commercial strategy. With a significantly growing market for organoids and other difficult-to-freeze cell types, such as 3D bioprints and primary tissues, we are experiencing an increased demand from customers using these cell types to develop new cell therapies. This referenceable DMF will greatly assist our customers when seeking regulatory approval for clinical product candidates.”
Richard McFarland, PhD, MD. Chief Regulatory Officer of Advanced Regenerative Manufacturing Institute (ARMI), added: “By filing a Device Master File, Cellbox GmbH aims to facilitate the regulatory review process for its partners and customers. This Master File will enable the efficient evaluation and approval of therapeutic products using CellBox.”
Cellbox Solutions´ technology is based on a unique portable live cell transport incubator combined with leading-edge live cell logistics solutions for healthcare companies.
About Cellbox Solutions GmbH
Founded in 2017, Cellbox Solutions GmbH focuses on innovative logistics solutions for the global healthcare industry, enabling transport logistics for difficult-to-freeze cells and clinical developers to deliver cell therapies to patients under the best physiological conditions. The Company´s portable CO2 incubator, Cellbox, provides a controlled and optimal environment for the transport of living cells and biological structures. Temperature and CO2 levels can be adjusted to ensure optimal incubation conditions. For more information, please visit https://cellbox-solutions.com/