CUMULUS Cryogenic Lyophilization and VERISEQ Nucleation

Improved Freeze-Drying of Valuable Biologicals and Active Pharmaceutical Products (APIs)
Our nitrogen-enabled cryogenic innovations, commercialized in partnership with IMA Life, enhance lyophilization, improving controllability, flexibility and product quality while reducing costs
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Controlled Nucleation

The challenge for successful lyophilization lies in controlling the nucleation temperature (the temperature at which a biological vial freezes). This is the most effective way of producing a homogenous structure within the product.

Lack of control can adversely affect the product’s uniformity due to suboptimal freeze-drying cycles. With our proprietary VERISEQ® Nucleation technology, liquid nitrogen creates a sterile ice fog that is distributed inside the freeze dryer to simultaneously and uniformly nucleate all of the vials. The uniformity provided by our nucleation technology results in a wide range of benefits, including accelerated cycle times, enhanced process control, process repeatability, improved product quality, and shorter reconstitution times. This technology is applicable to laboratory, pilot and production-scale freeze dryers with the added bonus of eliminating the need for pressure rating.

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Cryogenic Lyophilization

Traditional mechanical cooling systems can be replaced with cryogenic cooling solutions, targeting both the shelves and condenser coils. Based on our patented CUMULUS® design, our cryogenic lyophilization technology allows pharmaceutical producers to reach significantly lower operating temperatures than those previously possible with industry-standard silicone oil heat transfer fluids.

It also enables operators to ramp down temperatures at unprecedented rates. In addition to providing a reliable source of cooling, our solution eliminates the maintenance effort associated with compressors. And it integrates seamlessly into existing freeze dryers with its compact footprint.

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A Strong Partnership

VERISEQ Nucleation and CUMULUS LF technologies were developed by Linde. Our partner IMA Life exclusively distributes both application technologies.

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