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, Element 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 Element 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
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 Element'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.
Get a quote from our bioanalytical lab today.
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 Element 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.
Element’s comprehensive bioanalytical testing services are dedicated to bringing industry-leading scientific expertise to help customers advance drug development programs.
DMPK & ADME Services
Element offers a wide range of ADME and DMPK laboratory services, and we can accept both in vivo and in vitro samples.
Clearance Assays & Toxicity Testing
Element offers comprehensive, independent assessments of drug in vitro cytotoxicity and preclinical toxicology in addition to a well-developed collection of residual and clearance assays to confirm molecular clearance in animal-derived, complex matrices, including food.
Biopharmaceuticals and Biologics Analysis
Element’s significant expertise in all stages of biologics R&D, from in-house protein biochemistry and molecular biology to cellular biology and QC experience, supports the entire product development life cycle.