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2012 CPSA Conference: Vendor 5-Minutes of Fame! “Who is MicroConstants?” Ron Shevock Director, Business Development October 1 – 4, 2012, Bucks County Sheraton in Langhorne, PA
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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
Have YOU
Heard of
Have YOU
MicroConstants
?MicroConstants
?
quick show of hands
Where are we?For how long?
What do we DO?
dmpk
immunoassay
bioanalytical
clinical kits
Small molecules
peptides
immunogenicitymetabolite ID
CYP DDI
GLP
Method development
LC-MS/MSQ-TOF
IND-Enabling
clinical sample analysis
Wemeasure
stuff.
Does AnyoneDoes AnyoneStand out?Stand out?
quick show of hands
How about now?How about now?
Quality
Quality
Quality
QualityQuality
QualityQuality
Quality
Quality
Quality
Quality
Quality
Quality
Quality
Quality
Quality
Quality
Quality
QualityQuality
Everyone
says it
Wemeasure
it.
Annual Client
From 2010 - 2012, nearly
SatisfactionSurveys
HALF of our clients
responded
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
Othersmeasure
our qualitytoo
theFDA
A recent inspection (9/27/12)
found ZERO observations
Resulting in
NO form 483’s
Two PlatformsTwo Platforms
WatersWaters
SciexSciex
AND we tackle
TOUGH problems
AND we tackle
TOUGH problems
Who here is familiar with gentamicin?
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?
We already have.
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
How about validating assays for liposome encapsulated chemotherapy drugs?
Distinguish between the free drug and encapsulated form?
Protein bound drug
Encapsulated drug
disrupted liposomes
conversion to encapsulated form
No problem.
Our validated assays maintain and create separate analytical fraction for free and encapsulated drug.
To date, two major therapies have been successfully validated.
Have YOU
Heard of
Have YOU
MicroConstants
?MicroConstants
?
quick show of hands
Wemeasure
stuff.
How about now?How about now?
we tackle
TOUGH problems
we tackle
TOUGH problems
and we’re here to help
you
Thank you!
Ron ShevockDirector, Business Development | MicroConstants, Inc.Contact [email protected] linkedin.com/in/ronshev
