(PRWEB) July 12, 2007
Or-Yehuda, Israel Do-Coop Technologies Ltd., a privately held corporation based in Israel, announced that it has reached two significant milestones for Neowater, its proprietary water-based nanotechnology. A Type IV Drug Master File has been submitted to the US Food and Drug Administration (FDA) for Neowater. In addition, the first Current Good Manufacturing Practice (cGMP) Neowater manufacturing plant is operational in Israel.
Neowater is an enabling technology that is based on breakthrough water-based nanotechnology. Unlike traditional, dry nanotechnology, which focuses on a nanoparticle end product, Neowater builds upon the unique properties of nanoparticles to modify the physical properties of water molecules around them.
Each nanoparticle within Neowater, with its huge surface, creates an effect known as the "surface effect," and in turn organizes the water molecules surrounding it. This is similar to the surface effect of organelles within living cells. Both the organelles and the nanoparticles use this unique mechanism to create intracellular water. While the former is within cells and organs and cannot be harnessed nor used in a lab bench, the latter one, which is branded as Neowater, can.
This technology, developed in Israel, produces water whose physical properties mimic that of intracellular water using inorganic, insoluble crystals introduced in water in a patented process. Neowater, with its stable system of largely hydrated nanoparticles, like non-ionic detergent derived micelles, reduces the entropy of aqueous solutions. In addition, by design, since it exhibits both hydrophilic and hydrophobic properties it can be used as a unique solvent replacement.
Neowater DMF (for WFI) and cGMP production
Biotech and pharmaceutical companies have within their portfolios a significant amount of compounds and drugs which have been proven effective in vitro, yet they are very insoluble and thus unusable, such as novel cancer therapeutic drugs. Other compounds which are good drug candidates are too soluble, or they are prone to hydrolysis, both rendering them ineffective. While these companies are experts at screening and finding effective compounds, and they have invested millions in this effort, they often lack the expertise to overcome these challenging technological barriers and release these compounds to the market. Neowater technology allows such companies to capture the real value of otherwise valueless portfolios.
"Using Neowater, biotech and pharma companies can solvate their valuable compounds, enhancing both their stability and bioavailability, and thus can extend and protect their intellectual property and investments. We have packaged our enabling technology capabilities into a unique, simple-to-use service that can enable companies to reduce or replace polar solvents such as detergents and surfactants, alcohols and other broadly used solvents like DMSO, as well as to replace regular water and even lyophilization. Our customers have validated the performance of their Neowater-solvated compounds in their own laboratory and in pre-clinical tests, and have returned to us to license this unique capability," said Eran Gabbai, founder, President and CTO of Do-Coop Technologies, and the inventor of Neowater technology.
"Our customers have asked us to submit Neowater to the regulatory bodies, such as the US FDA, so clinical trials with the re-formulated compounds could begin as soon as their pre-clinical studies were completed. The submission of a Type IV DMF for Neowater to the FDA allows a convenient way for companies to cross-reference our filing in their regulatory submissions. In parallel to the regulatory review of Neowater, we have also designed, built and approved the first cGMP-compliant Neowater manufacturing plant, which is located in Israel. These milestones mean that our pharma customers can now start clinical studies for their compounds formulated with Neowater, and also avoid the need for a separate Neowater control in their studies," added Mr. Gabbai.
More details can be found in Do-Coop's web site Do-Coop site or by sending an email to info @ docoop.com