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PhytoCeutica,
Inc. 5 Science Park, Suite 13 New Haven,
CT 06511
Phone: 203-777-3462 Fax: 203-777-3538 E-mail: info@phytoceutica.com |
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PhytomicsQC™
Quality control (QC) is essential to determining
the consistency of botanical ingredients and to the final manufactured
botanical drug. While rigorous
clinical studies can address botanical drug safety and efficacy, there
are no well-accepted, modern standards for performing botanical drug
QC. Current mainstream QC methods
rely on technologies of the 1970s and focus on monitoring a few marker
chemical compounds and/or single enzyme/receptor bioactivities. This
approach, however, is inadequate in addressing the inherent complexity
of botanical extracts that can contain tens or even hundreds of phytochemicals.
For botanical medicine to truly succeed, the
adoption of a new, high-level standardized platform for assuring QC
is crucial. The hallmarks of
a modern QC platform for botanical drugs should include: (1) comprehensive,
molecular resolution chemical fingerprints with identification of
as many of the individual phytochemical constituents as possible;
(2) comprehensive, sensitive bioresponse fingerprint;
(3) statistical and quantifiable score function to define the
similarity of these patterns; (4) robust, reproducible, and cost effective
protocols for industrial use; and (5) integrated informatics database
for sample tracking, data storage and data analysis.
Such a platform has to assure both the regulatory agencies
and the public that the botanical drug is manufactured to high standards
that is consistent over time.
PhytomicsQC™ is a technology platform developed
and
patented by PhytoCeutica for the characterization of
botanical drugs. PhytomicsQC™
measures and compares global patterns of
the entire spectrum of phytochemicals and the synergistic interactions
of these phytochemicals on a living cell.
Specifically, PhytomicsQC™ comprises (1) an
integrated chemical fingerprinting methodology using state-of-the-art
LC/MS and an informatics platform for rapid chemical compound identification;
(2) a
novel biological response fingerprint using genomic expression
profiling; and (3) a statistical method to make quantitative comparisons
using the
Phytomics Similarity Index™ (PSI) for QC assessment.
The backbone of this system is
Phytomics Similarity Index™ an integrated database
(
PhytoInformatics™) and software package
for sample tracking, data storage/retrieval, data processing, signature
pattern selection, and quantitative pattern comparison.
PhytomicsQC™ provides an advanced and comprehensive
form of QC analysis for botanicals and it has been adopted as the
standard by the Consortium for the Globalization
of Chinese Medicine and is supported by funding
from National Center for Complementary and Alternative Medicine (NCCAM)
and the Office of Dietary Supplements.
For licensing of PhytomicsQC™, please contact
us at info@phytoceutica.com. |