Reduce costs and improve efficiency with short lead times and superior turnaround compared to other bioanalytical CROs. Maximize study ROI with high integrity data, even with small sample volumes. Whether you need help designing and developing, or simply need a trusted team to collect and analyze data, you’ve come to the right place.
Bioanalytical testing services
Bioanalysis and clinical biomarker services – Validate and improve upon existing methods or develop custom methods. Our vast knowledge of a diverse suite of biomarkers and multiple assay platforms can be applied using to methods for sample analysis, including quantitative analysis of biomarkers and drugs.
DMPK and ADME support – Advanced bioanalyses of a drug’s metabolic and pharmacokinetic profile include established and custom ADME assays and therapeutic drug monitoring (TDM). Method development and data collection fully support IND filings.
Toxicity and clearance assays – Perform in vitro cytotoxicity assays to ISO-10993-5 standards and analyze samples from preclinical toxicology studies. Determine dosing and reduce the risk of failure in later clinical trial phases with our support. Drug and food safety are supported more broadly when residual and clearance assays are applied.
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Our bioanalytical laboratory capabilities
Answer critical questions and solve outstanding problems with the right assays, methods, and platforms. To accomplish this, a variety of advanced tools are used in Element's bioanalytical lab, including the following instrumentation:
- Capillary Electrophoresis (CE, Protein Simple Maurice)
- Thermo Scientific Vanquish LC – QExactive+ System
- Ultra-Performance Liquid Chromatography (UPLC, Agilent) with ELSD, UV-DAD and FLD and Connected to TQD and QToF Mass Spectrometers
- High-Performance Liquid Chromatography (HPLC, Agilent) with UV-DAD, ELSD GCs with FID, MSD and TQD Detectors
- AB Sciex Triple Quadrupole API 2000 and 3000 Mass Spectrometers
- Dionex ICS-3000 Ion Chromatography System
- Agilent 7800 LC-ICP-MS system
- Mammalian Cell Culture Facility
- Droplet Digital PCR (dd-PCR)
- Cell Counter
- Micro-Plate Reader
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The Element advantage
An experienced bioanalytical contract research organization (CRO), Element is uniquely positioned to support challenging drug development projects and clinical research with a broad range of bioanalyses. Importantly, biomarker validation and custom assay development are central components, tapping into deep expertise with biomarker research and its clinical applications. This skillset is complemented with a complete offering of DMPK/ADME services and toxicity assessments.
Revolutionary biologic therapies, personalized medicine, and other major advancements require more refined and thorough bioanalytics to evaluate efficacy and ensure patient safety. The knowledge required to adeptly execute on the potential of bioanalytics is often overwhelming and not easily acquired, given an ever-expanding list of relevant biomarkers, in addition to the many analytical platforms needed for biomarker analysis.
We excel at the most demanding bioanalytical projects, and no problem is too complex to solve. So, let’s talk about your research and how bioanalytical testing can make a difference.
As you develop your vaccines, having assurance that they are safe is a critical regulatory requirement. Element provides vaccine analysis and safety testing.
Clinical Biomarker Support
Element's trusted team of experts can help drug developers identify, optimize, and execute the optimal approach to meet their clinical bioanalysis needs.
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.