Linde Gases has launched VERISEQ® Nucleation, an innovative cryogenic technology to control the formation of ice crystals during the lyophilization (freeze drying) process of biologics like proteins, vaccines and other injectables.
Using a sterile cryogenic ice ‘fog’ the technique results in enhanced lyophilization cycles and improved product quality for these valuable medical substances.
The temperature at which a vial freezes – the ice nucleation temperature - is critical in the process in order to optimize production times and improve quality of the final product.
The fog from the VERISEQ Nucleation rapidly spreads throughout the lyophilizing 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 minimizes product damage.
Linde has been collaborating with leading freeze drying equipment manufacturer IMA Life North America to test and demonstrate the new technology and according to the latter, test results demonstrate the system’s capability.
Joseph Brower, technology manager at IMA Life North America, said, “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.”
“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.”