Home > Press > Do-Coop Technologies Reaches DMF and cGMP Milestones for Neowater(TM), its Proprietary Water-Based Nanotechnology
Neowater has Submitted a Drug Master File (DMF) to the FDA; The First
cGMP-Compliant Neowater Manufacturing Plant is Operational in Israel
Do-Coop Technologies Reaches DMF and cGMP Milestones for Neowater(TM), its Proprietary Water-Based Nanotechnology
Boston, MA | Posted on May 7th, 2007
Do-Coop Technologies Ltd., a privately held
corporation based in Israel, announced today that it has reached two
significant milestones for Neowater(TM), 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
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.
Do-Coop Technologies will present Neowater technology at the Business
Forum (May 9th, 11:15 a.m., Room B, Drug Delivery Session) and also exhibit
during the Bio 2007 Annual International Convention in Boston, MA, May 6-9,
2007 (Booth #2087).
More details can be found in Do-Coop's web site http://www.docoop.com or by
sending an email to .
About Do-Coop Technologies Ltd.
Do-Coop Technologies Ltd. is a private company based in Israel. Do-Coop was formed in 1997 in order to develop and commercialize novel water-based materials using Nanotechnology for the biotechnology, pharmaceutical and chemical industries and for additional industries as well.
Do-Coop has developed a patented Nanotechnology to modify the properties of water using nanometer (one billionth of a meter) size particles (nanoparticles) that is enabling the first ever introduction of water-based biomaterials. The Company has spent over seven years developing and optimizing its first line of products, branded as Neowater™. Do-Coop has recently started commercialization of its first line of Neowater™-based products targeting the molecular diagnostics and research market within the Life Sciences industry and is now offering a new solubilization service for Pharma and Biotech companies to enhance bioavailability and solubility of existing and new drugs.
For more information, please click here
Do-Coop Technologies Ltd.
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