Pharmaceutical dehydration technology cuts time and costs
EnWave freezeREV is a multiple-vial prototype
EnWave Corporation of Canada has begun testing a multiple-vial prototype of its freezeREV pharmaceutical dehydration technology, which dries standard industry serum vials containing vaccines, injectable drugs, analytical enzymes, diagnostic reagents, antibodies and other biological materials. The prototype has a dehydration capacity of up to 100 vials an hour, and EnWave says it has shown significant potential to reduce the time and costs associated with drying vaccines and other biological materials.
‘We are building on the success of our single-vial freezeREV proof-of-concept technology, which has shown that we are capable of reducing the effort required to dry vaccines and other biological materials,’ said Tim Durance, joint chief executive of EnWave.
‘We have now begun the process of patent protection for this innovation, and initiated a search for a commercial partner who will work with us to scale and automate this technology, and meet industry and the FDA Good Manufacturing Practice standards.’
Lyophilisation (freeze drying), the industry standard dehydration technology, typically takes 24 to 72 hours to dry biomaterials. FreezeREV has the potential to dry vaccines and other biological materials more quickly and cheaply than freeze drying depending on the volume and physical characteristics of the starting material, the company says.
EnWave has conducted trials of the multiple-vial freezeREV prototype on three products, including a protein solution, a biologically active enzyme, and a live bacteria suspension, demonstrating reductions in dehydration time over freeze drying. Furthermore, the recovery of biological activity was equivalent to that obtained through lyophilisation, with final moisture content as low as 2.4%.
EnWave's proprietary Radiant Energy Vacuum (REV) technology combines microwave energy with vacuum pressure to produce high-speed dehydration of live or active pharmaceuticals in sterile vials.
The company has developed two versions of REV for use in drying live or active pharmaceuticals. BioREV is a dehydration method for materials which require a gentler drying process without extreme temperature changes or freezing. FreezeREV is for frozen material where low moisture levels in the final product are imperative for long product shelf-life.
