Results indicate reduced cycle times and increased product homogeneity are possible
Linde Gases, a division of The Linde Group, has developed technology for improving control and efficiency of pharmaceutical freeze drying processes. The company’s proprietary VERISEQ Nucleation controls the formation of ice crystals using a sterile cryogenic ice fog resulting in enhanced lyophilisation cycles and improved product quality.
Lyophilisation, used for stabilising valuable biologics such as proteins, vaccines and other injectables, is conducted in controlled environments and in compliance with strict regulatory guidelines. The temperature at which a vial freezes (ice nucleation temperature) is critical in the process to optimise production times and improve the quality of the final product.
According to Prerona Chakravarty, project manager for VERISEQ Nucleation, until now, there has been no commercially feasible way of achieving uniform ice nucleation, which could shorten operating cycles, improve yield and reduce overall uncertainty in scale-up. ‘Our technology provides a new degree of control leading to more robust lyophilisation cycles,’ she says.
VERISEQ Nucleation uses a sterile freezing mist (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,’ Chakravarty says.
Linde has been collaborating with leading freeze drying equipment manufacturer IMA Life North America, to test and demonstrate this technology. Joseph Brower, technology manager for 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 as well as incorporated into new installations.’