Pharmacokinetic Assays
Solutions
- Method Development
- Reagent development
- DOE driven method optimization
- Method Validation
- Method validation as per FDA, EMA, and other regulatory guidance
- Automated generation of validation report using Aegyris™
- Sample Analysis
- Automated sample receipt, verification, and accessioning process
- Highly automated sample dilution and Standards/QC preparation
- Automated generation of sample analysis report using Aegyris™
PK Assay Development = Reagent Generation + DOE + Right Technology Platform
Assay Development using DOE
Our custom de novo assay development services leverage the extensive and robust method development expertise in combination with reagent development expertise and DOE tools to deliver world-class methods to our clients in a timely manner.
Our unique combination of expertise in reagent development and DOE solutions differentiates us from any other CRO in the world.
Amplatto™ – Ultra-sensitive Detection
Immunoassays have been the method of choice for protein analyte measurements for more than four decades. However, the current immunoassay technologies, regardless of the detection methods, lack sufficient sensitivity to measure biologics at sub-picomolar levels which may be necessary for the evaluation of full pharmacokinetic profile. Somru Bioscience has developed a proprietary nanoparticle-enabled immunoPCR method, AmplattoTM , for the measurement of biologics at sub-femtomolar level.
Unleashing the power of Amplatto™ technology to achieve attomolar level of analyte detection.
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