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NIA 2013 (V1)

V12
by

Ideas in Motion

on 19 February 2014

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Transcript of NIA 2013 (V1)

Botanical Fingerprinting
and
Quality as a Competitive Advantage

Presented by
Elan Sudberg CEO & Sidney Sudberg CSO,
Alkemists Laboratories

The FDA's goal is to provide consumers with access to safe and effective products by fostering a compliant raw material and finished product supply chain.
More
Ockham's Razor
Occam's razor (or Ockham's razor)
lex parsimoniae, translating to the law of parsimony, law of economy or law of succinctness, is a principle that generally recommends, when faced with competing hypotheses that are equal in other respects, selecting the one that makes the fewest new assumptions.

The razor's claim is that "simpler explanations are, other things being equal, generally better than more complex ones" and is amenable to empirical testing.


The simplest explanation is usually the best.

The simplest answer is the one that requires no thought.

The simplest answer is usually the correct answer.

“Simplicity is the ultimate sophistication.”
Leonardo da Vinci (1452–1519)

We need to look at
“The forest for the trees.”
An old cliche!
What defines Quality & how can it be Ensured?
Quality: A Relative concept specified by each manufacturer
High purity vs. Broad Spectrum
Quality begins with the right plant/species!

Not reflected by single or multiple marker quantitation
Useful for process control & reproducible final dosage forms
Versus the Folk or Traditional use that has existed for thousands of years without analytical data

The chromatographic fingerprint
Homologous series of compounds separated over an entire chromatogram to compare to an authentic sample of the same &/or related species or plant parts.

More than just another Program
It is a philosophy, a way of life
Mechanically followed, doomed to failure
As a philosophy, a chance of success
As both, a program & a philosophy, chances of producing high quality products/data are excellent.

John K. Taylor, 1987 National Bureau of Standards

What are the Challenges with analyzing for Quality as applied to Plant Drugs?
There is inherent variability within the same plant materials, grower to grower, crop to crop as well as harvest &/or post harvest handling.

Quality of herbal drugs cannot be described quantitatively since they are not measured by single components but are measured as the complete/entire plant extract.

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Completely different philosophy of use & action of herbal drugs vs. isolated chemical compounds, which is why different analytical tools are required.

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The drug substance is the plant or extract & the drug product is the formulated herbal product.

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There are difficulties inherent in trying to apply pharmaceutical current Good Manufacturing Practices (cGMP) to botanical products.

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The FDA assembled a pharmacognosists dream team
The industry is now at liberty to decide between three paths
Fit for Purpose testing is a quickly growing concept of effectively complying with the GMPs.
Is this really necessary???
Conceptualizing Botanical Fingerprint Interpretation by HPTLC
The Marker
Approach

The Multi-Marker
or
Component Approach
The Pattern Approach

NIST/NIH
Dietary Supplement Laboratory Quality Assurance Program: Ginkgo biloba
The Multi-Pattern Approach

The Something Awoke the FDA....
Adulteration/Contamination
Plantago lanceolata Digitalis lanata
Techniques to combat adulteration & contamination have been available to us all for many many years.
oGMPs...
Overview
Challenges of Botanical Identity & Quality
cGMP’s
Adulteration
Marker evaluation for internal Batch/Process control

Fingerprint/Pattern recognition
Various approaches & applications

The Functional Fingerprint & the concept of Phytoequivalence

Vanguard/Rearguard testing strategy

Plant Drug Quality & Analysis
HPTLC:
A Fit-for-Purpose
Application
Chromatographic & other techniques used:

HPTLC, HPLC, GC, CE have all been used for identity
Spectroscopic methods such as IR, NMR & UV/vis also used for fingerprinting

DNA fingerprinting of herbal materials is now being used & explored for authentication of botanicals where applicable.

Detection of Adulteration
A common problem in this industry, either purposeful, accidental or simply poor quality GAP’s

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Identification of Raw Materials
& Finished Products

Visual evaluation of a TLC plate allows for comparison of many samples side by side

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Philosophy Lesson of the day
Instead of ‘zooming in’ which is necessary for impurity/trace analysis, the bigger picture is essential here!
Figure 1. The Marker Approach; illustrating the differentiation between P. multiflorum root from P. cuspidatum root and stem.
Lane 2(3µl) Schisandra chinensis (fruit); Lane 3(3µl) Schisandra chinensis (fruit); Lane 6(3µl) Schisandra sphenanthera (fruit); Lane 7(3µl) Schisandra sphenanthera (fruit)

The Multi-component Approach; utilizing the presence/absence of Echinacoside and Cynarin, lane 1, Caftaric acid and Cichoric acid, lane 8 to differentiate between various species of Echinacea.

The Pattern Approach; distinguishing P. notoginseng from among various species of Ginseng.
The Pattern Approach; utilizing a multi-component authenticated reference botanical to identify and distinguish A. sinensis from a related species A. archangelica & the common adulterant Levisticum officinale.

The Pattern Approach; as applied to a poly-herbal blend for the identification of one component in the blend, Coptis chinensis.

The Multi-Pattern Approach; analyzing Hoodia gordonii using the Analytical Triad consisting of the


HPTLC chromatographic fingerprint analysis
Microscopic analysis revealing a fiber with whirled striations somewhat unique to the Hoodia species.
Vanguard–Rearguard
Strategy of qualitative analysis
Further evaluation of samples for quantitative evaluation of specific markers after the samples have been qualified by the Vanguard system


These concepts are being used to simplify the QC process of qualitative analysis for botanical identification.


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Accurate, precise, expensive & time-consuming procedures utilizing conventional instrumentation (e.g., MS, NMR, GC/MS, LC/MS, etc.; Rearguard)


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HPTLC fingerprint is representative of this strategy which can be used to screen large numbers of samples.


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Rapid, low-cost analytical systems (Vanguard) providing a yes/no answer for screening of identity, quality &/or safety.


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Functional Fingerprints & Phytochemical Equivalence
Markers can ensure that consistent products are maintained from lot-to-lot, from year to year, throughout the shelf-life assigned to your products.



Markers & chromatographic fingerprinting facilitate manufacturing controls & allow herbal drugs to be manufactured under cGMP!



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Therapeutic potential is just as likely to be a function of a single compound in low concentration as it is to be a unique ratio or combination of multiple compounds to one another.



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Lot-to-lot consistency can be maintained by establishing validated controls for plant raw materials; validation of the manufacturing process & quantification of a chemical marker to assure potency & uniformity of dosage forms, to assess the stability of the formulation & to perform validation of test methods.



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Quality may be relative but the true reflection of quality is based on its’ specified therapeutic potential.



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Concept Formation
The Psychologist, Carl Jung, once said, “The forlornness of consciousness in our world is due primarily to the loss of instinct, and the reason for this lies in the development of the human mind over the past aeon.

The more power man had over nature, the more his knowledge and skill went to his head, and the deeper became his contempt for the merely natural”. Carl Jung, 1950

Remember Ockham's razor

The Paradigm Shift
Differentiation
Today's marketplace
Quality as a Competitive Advantage
Really???
value proposition
value proposition
value proposition
value proposition
value proposition
value proposition
value proposition
value proposition
value proposition
value proposition
value proposition
Why should potential customers use your services over others?
Marketing Relevance
Showcasing your company’s superior quality system in your marketing can produce that “unfair” competitive advantage we all seek.
Quality control is a must

cGMPs to be upheld

483 notices

The FDA is watching

Some of your suppliers are trying to cheat you...
OLD NEWS
Turn Around Time
Quality
Price
QUALITY COUNTS
Your Customers Care
The customer is always right.
AND we get to choose who our customers are...
well, most of them...
So what???

What does this all mean???

Why should we care???
What connects the internal and the external is a growing desire for confidence that what is on the label is in the bottle.
Letting your customers know the superior quality system your company upholds in light of your competitor’s shortcomings might produce that “unfair” competitive advantage to differentiate your brand from others.
The only reason it may be considered “unfair” is because it takes profit-eating investments of money and time to set up, maintain, and grow.
That is why your competitors have chosen the path of least resistance with a quality system that barely makes the cut. Don’t follow their lead. Create your own path of least resistance by marketing an exceptionally important behind-the-scenes/invisible feature:
quality assurance.
Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

Raw Material variability assessment:
Consistency of bulk herbal material is essential in obtaining consistent final products!

http://www.naturalproductsinsider.com/blogs/supplement-perspectives/2013/06/qa-as-marketing.aspx
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