Bioanalysis AAPSvideo 101911 kh

Slide 1: 

Pharmaceutical Companies and the World of Bioanalysis Desired Profitability Not achieved More Unknowns Time to market too long Desired Sensitivity unachieved

Slide 2: 

Drug Development Process Pre-clinical Development Phase III Phase II Challenges in Every Step of Regulated Bioanalysis Phase I Clinical Trial Lead Optimization Complicated drug design process High throughput necessary Optimize drug and manufacturing process Accurate DMPK results R egulatory guidelines Minimize cost/sample Optimize data in shortest time Ensure reduced cost/sample & maximize uptime Prepare data for submission Ensure faster time to market

Waters Gave YOU Sensitivity: 

Chemistry ACQUITY Family Xevo Family Informatics Waters Gave YOU Sensitivity “…real life levels of sensitivity unprecedented from a triple quadrupole spectrometer” Chris Evans, GSK “ When compared to earlier generation spectrometer models, MicroConstants experienced a forty fold increase in sensitivity with compounds tested internally in negative electrospray ionization mode “ Microconstants (CRO) “ …for us, this [ACQUITY UPLC] constitutes the Biggest step change in mainstream chromatography In the last 25 years.“ Richard Houghton and Philip Grace Quotient Bioresearch (CRO) Fluticasone Propionate 0.75 pg/ mL

Your Unmet Challenges in Bioanalysis: 

Maximize u ptime Your Unmet Challenges in Bioanalysis Reduce cost/sample Regulatory changes Peptide therapeutics Peptide biomarkers High throughput

Slide 5: 

BEYOND SENSITIVITY IN BIOANALYSIS Reduce cost/sample; Maximize uptime Speed of analysis Address regulatory requirements Peptide biomarkers and therapeutics

Slide 6: 

Reduce Cost per Sample; Maximize Uptime Efficient and variety of sample preparation and column chemistries Ease of use, from method development to performing batch analysis Desired reproducibility achieved with ease High throughput capabilities with best spectral quality Be compliant while obtaining data

Slide 7: 

Speed of Analysis Analysis times as low as 45 seconds with ACQUITY UPLC I-Class

Slide 8: 

Address Regulatory Guidelines Matrix Factor Automatically Calculated UNIFI: The Only Software You Need Enables LC, MS, and data management Be compliant and validated for your environment Scalability Workflow-based design with easy user access

Slide 9: 

Peptide Therapeutics Desmopressin 1 pg/ mL Oasis, UPLC, Xevo TQ-S

Slide 10: 

Success by Partnership with Waters Reduce cost/sample; Maximize uptime Speed of analysis Address regulatory requirements Peptide biomarkers and therapeutics Success

What Will YOU Do With: 

What Will YOU Do With