EnWave Announces Positive Monoclonal Antibody Dehydration Test Results Using freezeREV™ Technology
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EnWave Corporation has announced that it has received positive results from a 12 month study comparing the Company's freezeREV™ dehydration technology against the standard industrial drying method, freeze drying, in the dehydration of pure samples of FITC-conjugated and unconjugated animal-derived monoclonal antibody ("the antibody", or "the protein").
The results show that the drying methods were equivalent in terms of the structural changes incurred by the protein both immediately post-dehydration, and over the course of the 12 month shelf-life period, but that the samples dried using EnWave's single-vial freezeREV™ prototype were produced in 20 minutes versus the typical 48 hours required for freeze drying.
"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," stated Dr. Tim Durance, EnWave's Chairman and Co-CEO.
Dr. Durance contact, "We have now demonstrated positive results for our freezeREV™, bioREV™, and powderREV™ technologies using a variety of biomaterials including bacteria, enzymes, antibodies and one virus that show the potential for significant reductions in pharmaceutical processing times and operating cost savings over lyophilization."
Produced by the human and animal lymphatic systems, antibodies are integral to the ability to fight infection and disease. Antibodies are also used for medical research and diagnostics, prenatal therapy, and treatment of diseases such as cancer, heart disease, rheumatoid arthritis and multiple sclerosis.
Although antibodies are not considered live organisms, dehydration can cause them to become inactive, and therefore ineffective for use in pharmaceutical and other products, by changing or "denaturing" their outer protein structure.
In September 2009, the Company announced that it had received positive results from preliminary dehydration tests conducted on three polyclonal antibodies obtained from animal sources, and the current test results are a significant additional finding because monoclonal antibodies are much more sensitive, and therefore prone to degradation during dehydration.
Furthermore, the bulk of biotechnology research into the use of antibodies for medical therapy relies on monoclonal antibodies which, in liquid format, require shipment and storage at temperatures as low as -80 degrees C in order to maintain their bioactivity.
Samples produced for this study were generated by scientists at EnWave's Biomaterial laboratory. The University of British Columbia AbLab (Antibody lab) performed the analysis independently over the course of study.
The laboratory employed a common method known as Fluorescence Activated Cell Scaning (FACS analysis) to evaluate the degree of structural change both post-dehydration and over the 12 month shelf-life where the dried proteins were kept at 4 degrees C and 25 degrees C.
