Сòòò½APP

Readily detect and measure relevant biomarkers and understand drug performance. Methods are developed to clearly separate analytes of interest for accurate quantification in the full context of biological systems, given our decades of experience in analytical chemistry and biology. 

From bioanalytical method development to clinical trial support and everything in between, Сòòò½APP makes an impact for our partners. Want to know more about our high-quality data collection, analysis, and fast turnaround times? Let’s talk. 

Clinical biomarker and bioanalysis services

Partner with Сòòò½APP to:

• Develop, validate, and transfer both existing and custom assays for novel biomarkers and therapies
• Transfer existing assays to alternative analytical platforms
• Maximize analytical platforms including ddPCR, immunoassays, and LC-MS bioanalysis (Orbitrap QExactive and other systems)
• Use NMR to help identify completely novel biomarkers
• Increase sensitivity and determine ppb/ppt limit of detection (LOD)
• Develop and work with both single-plex and multi-plex assays
• Execute high throughput testing of clinical samples

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Bioanalytical method development, validation, and transfer

Method Optimization - Increase efficiency, robustness, sensitivity, selectivity, and ease of use of existing methods, while identifying potential liabilities and de-risking regulated issues.

Method Development - Custom methods and assays for well-known and obscure biomarkers are developed under the strict quality controls required by regulatory bodies (like the FDA and EMEA) and standards, including ISO, GLP, and GMP guidelines. Quality control is embedded into Сòòò½APP's clinical biomarker services, from beginning to end, given the high-stakes environment of clinical research and regulatory approval.

Method Validation - Sample collection, stabilization, and extraction techniques are specifically optimized for individual biological matrices, biomarkers, and drugs, collectively circumventing common challenges associated with using a bioanalytical assay on patient samples.

Method Transfer - Effective method transfer is as an essential component for making work actionable. We work diligently to ensure information is properly transferred for the long-term success.

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High throughput bioanalysis

Sample analysis both preclinical and clinical research are executed according to previously established methods or those we’ve developed, in addition to custom biomarker assay services and bioanalytical method validation.

Save precious time and lab resources while bioanalytical laboratory acts as an extension of your team, applying world-class expertise to analyze samples using preferred methods quickly and carefully.

The Сòòò½APP advantage

In addition to optimizing existing methods and developing new ones for a variety of drug and biomarker studies, a number of analyses can be performed out the gate without sacrificing data quality, offering tremendous benefits in terms of turnaround times. Looking to talk about your biomarker and clinical trial support needs? Speak with an expert.