Cryopreservation of blood cells, somatic cells, stem cells, ATMP, cell therapeutics, cell-based gene therapeutics and therapeutical cell compartments like mitochondria, ribosomes and exosomes

The microdrop vitrification method enables successful cryopreservation of therapeutic cells and cell components without the use of cryoprotective additives that can harm the product or joepardize regulatory approval. The therapeutic product is converted into micro-granules that can be stored long-term and portioned, allowing for direct clinical application.

ILK Dresden has developed several continuous-flow methods for the vitrification of biopharmaceutical products - such as blood and cell suspensions - in a way that preserves viability. The electrospray (ESI) method enables the high-throughput vitrification of robust biological products like blood, whereas the micro-droplet method allows for the gentle, batch-wise cryopreservation of highly sensitive biological products, such as stem cells or cell organelles.

By breaking the product down into monodisperse droplets with an adjustable volume of 0.5 to 5 nanoliters, micro-droplet vitrification enables the gentle cryopreservation of biopharmaceutical products at extremely high cooling rates of up to 4.5 million°C per minute. This rapid cooling allows the aqueous product to vitrify directly without the formation of harmful ice crystals. Unlike conventional vitrification methods used in reproductive medicine - which achieve cooling rates of only a few thousand degrees Celsius per minute - this process enables cryopreservation that preserves viability and functionality without the addition of highly concentrated cryoprotective agents (such as DMSO) that could compromise the product or jeopardize regulatory approval.

The result is a cryogenic, portionable granular product that allows for the long-term storage of the cryopreserved material while fully preserving the viability and functionality of its biological components. By simply drawing up a lukewarm buffer, the cryopreserved granules can be reconstituted within the syringe into a ready-to-use suspension containing therapeutically active cells or cell components.

ILK Dresden is currently conducting successful research into the freeze-drying of the vitrified product. The goal is to enable uncooled storage of allogeneic cell therapeutics for several months. Successful freeze-drying of therapeutic mitochondria has already been demonstrated in animal studies.