Medical cold chain for gene and cell therapies

With more than 40 years of experience in protecting thermosensitive specimens from temperatures excursions, B Medical Systems is a specialist in the medical refrigeration industry and has supported research and clinical institutes around the world for many years. The company’s Medical Refrigeration product portfolio includes models offering safe storage environments for a wide range of different samples and specimens.

To create a reliable cold chain for clinical efforts in the spaces of cell and gene therapies, it is important to understand the nature of the samples needing storage: while cell therapies will mostly have products consisting of mammalian cells, gene therapy ones are made of genetic material, and all these biologicals require different storage temperatures to maintain their viability.

Ultra-Low Freezers, or ULTs, are designed to safely store human cells, genetic material, and other biologicals for extended periods of time at temperatures as low as -86°C. Similarly, Laboratory Refrigerators and Freezers are designed to preserve the integrity of valuable samples at temperatures between 4°C to 15°C and -41°C to -20°C, respectfully. They are ideal solutions for the short-term storage of biologicals and the support of healthcare workers in the last stages of medicine delivery by preserving important therapeutics.

B Medical Systems’ ULTs provide superior door opening recovery and holdover times, ensuring a stable storage environment even during adverse events. The variable operating temperature (-86°C to -20°C) offers flexibility to operations for storage of various types of specimens. The Laboratory Freezers are designed with smart defrosting technology thereby delivering uniform temperature inside the cabinets even during auto defrost cycles. All these products are certified medical devices (Class I/II) by EU MDR/US FDA. The products also use natural refrigerants, conform to EU F-gas and US SNAP regulations, and offer superior energy efficiency.

Finally, Laboratory Refrigerators are designed also for the storage of biologicals used in cell and gene therapies: for example, right before administration, samples may require thawing and storage environments at 4°C to 15°C are ideal for that. With their superior cooling systems, these medical refrigerators can provide the best levels of reliability. The company offers a wide variety of models, including undercounter refrigerators, refrigerator/freezer combo units, and double-door refrigerators for large stock management.

The company also offers 24/7 real-time monitoring solutions enabling an extra layer of sample safety, allowing designated services to constantly track their cold chain solutions and be updated on the condition of their contents.

B Medical Systems’ models are renowned worldwide for their safety, quality, reliability, and energy ef?ciency, and are used globally to support advanced medical research efforts by protecting important samples from dangerous temperature deviations.

This article was originally published in Autumn Edition European Biotechnology Magazine 2021.