19 tackling tough bioanalytical challenges micro constants' novel approach to internal...
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5 minutes of fameTRANSCRIPT
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2012 CPSA Conference: Vendor 5-Minutes of Fame!
“Who is MicroConstants?”
Ron ShevockDirector, Business Development
October 1 – 4, 2012, Bucks County Sheraton in Langhorne, PA
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Have YOU
Heard of
Have YOU
MicroConstants
?MicroConstants
?
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quick show of hands
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Where are we?For how long?
What do we DO?
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dmpk
immunoassay
bioanalytical
clinical kits
Small molecules
peptides
immunogenicitymetabolite ID
CYP DDI
GLP
Method development
LC-MS/MSQ-TOF
IND-Enabling
clinical sample analysis
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Wemeasure
stuff.
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Does AnyoneDoes AnyoneStand out?Stand out?
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quick show of hands
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How about now?How about now?
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Quality
Quality
Quality
QualityQuality
QualityQuality
Quality
Quality
Quality
Quality
Quality
Quality
Quality
Quality
Quality
Quality
Quality
QualityQuality
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Everyone
says it
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Wemeasure
it.
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Annual Client
From 2010 - 2012, nearly
SatisfactionSurveys
HALF of our clients
responded
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a FULL 100% said they were satisfied with the quality of work
produced by MicroConstants
a FULL 100% said they were satisfied with the quality of work
produced by MicroConstants
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Othersmeasure
our qualitytoo
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theFDA
A recent inspection (9/27/12)
found ZERO observations
Resulting in
NO form 483’s
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Two PlatformsTwo Platforms
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WatersWaters
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SciexSciex
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AND we tackle
TOUGH problems
AND we tackle
TOUGH problems
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Who here is familiar with gentamicin?
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Who wants to develop an isotopically labeled I.S. that contains analogues of each gentamicin component for an
LC/MS/MS assay with small sample volume and a 1.00 ng/mL LLOQ?
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We already have.
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The Solution
• Stable labeled I.S. is synthesized by pre-derivatization with d7-PCF
• I.S. is added at the beginning of extraction but is not derivatized within the assay
• Gentamicin isoforms in samples are derivatized within the assay by non-labeled PCF
R
RI
NH Cd7O
O
C ClR
RI
N C OCd7
O
+
Amine Propyl-d7 chloroformate Propyl-d7 carbamate
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How about validating assays for liposome encapsulated chemotherapy drugs?
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Distinguish between the free drug and encapsulated form?
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Protein bound drug
Encapsulated drug
disrupted liposomes
conversion to encapsulated form
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No problem.
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Our validated assays maintain and create separate analytical fraction for free and encapsulated drug.
To date, two major therapies have been successfully validated.
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Have YOU
Heard of
Have YOU
MicroConstants
?MicroConstants
?
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quick show of hands
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Wemeasure
stuff.
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How about now?How about now?
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we tackle
TOUGH problems
we tackle
TOUGH problems
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and we’re here to help
you
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Thank you!
Ron ShevockDirector, Business Development | MicroConstants, Inc.Contact [email protected] linkedin.com/in/ronshev