Category: Uncategorized

New 10DX Vapor Shipper for Large Quantities of Biomaterials in Regulated Environments

The new IC Biomedical 10DX vapor shipper is designed for shipping biomaterials in larger quantities and can be validated to the longest hold time in the industry for a shipper of its size. With a 5-cryobox capacity or space for multiple bag cassettes, the 10DX is a very versatile vessel. Our uniquely designed shipping case (Model 10LSC) provides excellent protection for the 10DX during road or air shipments.

Many of the typical end-user applications for the 10DX are in regulated environments. Compliant data logging options during shipment are available, including simple temperature logging, full GPS tracking, tilt and ambient environment recording.

The 10DX uses a Hydrophobic Adsorbent material that can be easily decontaminated between shipments if required by the application.

For more information on our full line of vapor shippers, click here.

Ian Pope Teaching in BioCor’s “Preservation of Cellular Therapies” Short Course at the University of Minnesota

On May 23 – 24, 2023, The University of Minnesota is presenting a top-notch short course titled “Preservation of Cellular Therapies.” IC Biomedical’s Chief Commercial Officer, Ian Pope, a thought leader and acknowledged expert in cryogenic and ultra-cold storage and transport, is part of the distinguished teaching group for this 2-day course.

Currently 1.2 million patients are receiving treatment from regenerative medicine products produced by 171 companies with a capital value of ~$4.7 billion. Most molecules, cells and tissues are collected at a given time and location for use at a later time. Therefore, our ability to stabilize biological properties (e.g. viability, biomarkers) during transportation and long-term storage is a critical technology.

The preservation of cellular therapies is the central focus of this professional short course. Learn about the fundamentals of preservation, protocol development, design of a storage facility, regulatory issues associated with preservation of cell therapies, clinical issues and more.

Click here for more information and to register.

ISO 13485:2016 Certification Achieved

MARCH 2022 – One of the first strategic goals for IC Biomedical was to build a world class biomedical cold storage business and to manufacture our products in a medical device compliant facility.  The key step to achieving global medical device compliance was the development and certification of an ISO 13485:2016 Quality Management System (QMS).   An ISO 13485:2016 QMS is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.  Additionally, the required processes ensure medical devices and related services consistently meet customer and applicable global regulatory requirements.

IC Biomedical is proud to announce ISO 13485:2016 certification was achieved in March 2022, less than a year after the Cartersville GA manufacturing facility was opened.  This certification is a key step in obtaining global medical device approvals and registrations for all IC Biomedical products.