Methods to cut cycle times for freeze drying, or lyophilisation, from days to hours while maintaining product quality have been widely researched by academia and industry. EnWave has developed freezeREV for this purpose and is gathering data to validate the process.
“This is an important result for EnWave as we continue to build a comparative profile of REV against freeze drying for biomaterials used in the pharmaceutical and agricultural sectors”, Tim Durance, chairman and co-CEO of EnWave.
In a study, monoclonal antibodies (mAbs) dehydrated using freezeREV and lyophilisation showed similar structural changes immediately after processing and following one year on the shelf. Changes to samples kept at 4°C and 25°C were assessed using fluorescence activated cell scanning.
Similar results were achieved despite the difference in cycle times. Lyophilisation drying rates are limited by the temperature the product can tolerate before it melts or collapses during the shift from solid to gas phase. As such, lyophilisation can take days.
In contrast, a single-vial freezeREV prototype dried samples in 20 minutes, EnWave claims. Cycle times are shortened by combining microwave heat energy with a low pressure environment.
“We have now demonstrated positive results…that show the potential for significant reductions in pharmaceutical processing times and operating cost savings over lyophilisation”, Durance said.
Cost savings are expected to be realised through cuts to the labour, raw materials, energy and time it takes to process materials. EnWave has single- and multi-vial prototypes ready for testing.
Results from the mAb study follow earlier dehydration tests on polyclonal antibodies. The earlier research found no detectable visual difference between freezeREV and lyophilisation dried antibodies.