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Bioanalysis - I&L Biosystems · 2019. 9. 16. · VIA LC-MS/MS WAS TESTED IN THE FRESH SOLUTION AND...
Transcript of Bioanalysis - I&L Biosystems · 2019. 9. 16. · VIA LC-MS/MS WAS TESTED IN THE FRESH SOLUTION AND...
Frozen Aliquotting Preserves Biomolecule Integrity
Frozen Aliquotting in Drug DevelopmentFrozen aliquotting prevents degradation due to freeze-thaw, improving ADME, Tox and
clinical PK results for labile pro-drugs, peptides, and antibody-drug conjugates. Frozen
aliquotting enables quantitative analysis of blood samples. Using frozen aliquotting for
whole blood, which cannot be assayed reliably when thawed, eliminates processing
steps and improves the accuracy of drug and biomarker test results.
Frozen sample aliquots are easily distributed in all phases of clinical trials,
facilitating multi-site testing and enabling pre-analytical sample QC and expansion of
testing parameters. Uncompromised parent samples can be maintained for reference
or retrospective studies.
You can with Frozen Aliquotting.
“We’re performing DMPK and ADME/Tox testing. Can we eliminate freeze-thaw cycles to analyze unstable compounds?”
“My trial requires clinical chemistry and biomarker testing. Can I distribute aliquots to multiple labs without thawing?”
“We’re having trouble with incurred sample reanalysis. Can we avoid freeze-thaw cycles to improve ISR results?”
Bioanalysis
STORE PARENT SAMPLE
Archive for ISR or retrospective testing
TEST ALIQUOTS
Use frozen aliquots to complete multiple tests
CORE SAMPLE
Generate Frozen Aliquots
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Seeing is BelievingSchedule an on-site demonstration of the CXT 353 Frozen Sample Aliquotter or a demonstration of the CXT 750 Automated Frozen Sample Aliquotter.
Top Five Benefits of Frozen Aliquotting
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Basque Engineering and Science, 33 Centre Street, Danvers, MA 01923 | 1.617.962.0309 | www.basque-engsci.com cryo-bioanalysis/9-2017
Test Labile Compounds5% to 10% of drug molecules are inherently unstable. Frozen aliquotting of
tissue and biofluids stabilizes small molecules and peptides for ADME/Tox
and DMPK testing. Frozen aliquots can be directly deposited into organic
solvent for LC/MS-MS analysis. In the study below completed at GSK, two
small molecules started degrading following 1 to 2 freeze-thaw cycles, but
maintained integrity with frozen aliquotting.
Cisatracurium in Human Plasma
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Cisatracurium in Rat Plasma
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Caffeic Acid in Human Plasma
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Caffeic Acid in Rat Plasma
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FIGURE 1. CAFFEIC ACID AND CISATRACURIUM WERE SPIKED INTO HUMAN AND RAT PLASMA. RECOVERY
VIA LC-MS/MS WAS TESTED IN THE FRESH SOLUTION AND FOLLOWING FREEZE-THAW. THE GRAPHS SHOW
PEAK AREA COUNTS FOLLOWING 0 TO 4 FREEZE-THAW CYCLES.
Analyze Drug Distribution in TissueA critical aspect of drug development is an understanding of tissue
distribution and metabolism.
Comparing levels in heart, lung, liver,
kidney, and brain provides important
information regarding drug function
and clearance1.
Analyzing distribution within a specific
tissue type can help researchers
determine how certain drugs penetrate
the heart or understand the distribution of brain penetrative compounds.2,3
Frozen aliquotting enables researchers to collect precise frozen tissue
sections and compare distinct locations within a sample.
1. Tan, et al. (2014). J. Pharmaceutical Tech. & Drug Rsch., doi: 10.7243/2050-120X-3-1
2. Tylutki, Z., et al. (2015). Biopharm. Drug Dispos., 36(6):337-351
3. Swales, J.G. et al. (2015). Anal. Chem., 87(19):10146-52
ANALYZE LABILE DRUG COMPOUNDS
Access samples without thawing
SHIP SAMPLES TO MULTIPLE LABS
Distribute frozen aliquots
IMPROVE ISR RESULTS
Avoid freeze-thaw cycles
ENABLE PRE- ANALYTICAL QC
Test frozen aliquots for sample quality
STUDY DRUG DISTRIBUTION
Capture precise tissue sections
Freeze-Thaw Aliquotting Frozen Aliquotting Baseline Extrapolated
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