Linde Gases, a division of The Linde Group, has launched Veriseq Nucleation, an innovative cryogenic technology to control the formation of ice crystals during the lyophilisation - or freeze drying - process. Using a sterile cryogenic ice "fog" the technique results in enhanced lyophilisation cycles and improved product quality.

"Until now, there has been no commercially feasible way of achieving uniform ice nucleation, which has resulted in prolonged operating cycles, reduced yield and overall uncertainty in scale-up", said Art Shirley, Head of Chemistry and Energy, Linde Gases Division.  "Linde’s Veriseq Nucleation technology will provide end users a new degree of control leading to more robust lyophilisation cycles."

Biologics like proteins, vaccines and other injectables must remain effective from manufacture to patient administration. These substances are expensive, fragile and can lose their efficacy during storage. Lyophilisation is a dehydration process for stabilising these valuable medical substances that is conducted in highly controlled environments and in compliance with strict regulatory guidelines. The temperature at which a vial freezes – the ice nucleation temperature - is critical in the process in order to optimise production times and improve quality of the final product.  

Veriseq Nucleation uses a sterile freezing mist - a type of ice "fog" - that rapidly spreads throughout the lyophilising chamber and causes all vials to freeze at the same time and at the desired temperature. Controlling the nucleation temperature produces the preferred ice structure within the product which reduces processing time and minimises product damage.

Linde has been collaborating with leading freeze drying equipment manufacturer IMA Life North America to test and demonstrate the new technology.

"Test results demonstrate the feasibility of Veriseq Nucleation for both small-scale development and large-scale aseptic manufacturing. Results also indicate that both reduced cycle times, and increased product homogeneity are possible", said Joseph Brower, Technology Manager, IMA Life North America. "The advantage of Veriseq Nucleation is that it can be retrofitted to existing freeze dryers as well as incorporated into new installations, and initial customer feedback from demonstrations has been very positive."

The Linde Gases Division, part of The Linde Group, is a leader in the international industrial and healthcare gases markets, providing compressed, bulk, specialty and medical gases, as well as chemicals to virtually all fields of industry globally.