Element recognizes, understands, and meets the need for a collaborative, trusted contract research organization (CRO) and contract development and manufacturing organization (CDMO) that offers comprehensive clinical biomarker services, including robust and sensitive bioanalysis and bioanalytical method development and validation to measure the activity and potency of drugs and therapies.
Bioanalysis and bioanalytical method validation are integral aspects of any preclinical and clinical research program. In addition to assessments of clinical outcomes, organizations developing potentially life-changing therapeutics must be able to carefully measure key biomarkers from clinical samples in to determine efficacy and safety on a molecular level. When done properly, bioanalytical method development empowers clinical research, precisely and accurately tracking drug levels in addition to patient response to therapy. In turn, clinical trials are fortified through the collection of data concentrating on the drug’s behavior and mechanism of action.
The diversity of potential biomarkers, novel drugs, biological matrices, methodologies, and analyses can complicate bioanalysis and biomarker testing, despite its significance in clinical research. It can be a challenge to find, optimize, and execute the approach best suited for your clinical bioanalysis needs, given the many aspects that must be considered and evaluated. Particularly for companies lacking infrastructure and necessary equipment, partnering with a contract research organization (CRO) and contract development and manufacturing organization (CDMO) with expertise and experience in LC-MS bioanalysis and clinical biomarker services is critical to successfully bringing drug candidates to market.
Element’s purpose-built bioanalysis and clinical biomarker services help our partners readily detect and measure relevant biomarkers, understand drug performance, and provide clinical trial support. Our team maintains both an up-to-date knowledge of the bioanalytics landscape and the advanced instrumentation required to skillfully conduct any bioanalysis request, from bioanalytical method development to clinical execution and everything in between. Our trusted team of experts understand what it takes to construct a method that clearly separates analytes of interest for accurate quantification in the full context of biological systems, informed by decades of experience in both analytical chemistry and biology. As a true partner, Element can then act as your bioanalytical laboratory, performing data collection and analysis as needed, with fast turnaround times and a strong commitment to quality.
Clinical biomarker services
- Fit-for-purpose single-plex and multi-plex custom assay development, validation, and transfer for novel therapies and biomarkers
- Existing therapy and biomarker method transfers, including the transfer of bioanalytical methods to alternative platforms
- Novel biomarker identification via nuclear magnetic resonance (NMR)
- Enhancement and improvement of existing methods, including the determination of ppb/ppt limit of detection (LOD) and increased method sensitivity
- Prompt and thorough clinical sample testing in a high throughput environment
Biomarker and bioanalytical method development, validation, and transfer
Element’s consultative team collaborates with our customers to improve efficiency, robustness, sensitivity, selectivity, and ease of use of existing methods, in addition to identifying potential liabilities and de-risking regulated issues. Alternatively, our bioanalytical laboratory can design custom methods and assays for well-known and obscure biomarkers alike, developing them under the strict quality controls required by regulatory bodies (such as the FDA and EMEA) and standards, including ISO, GLP, and GMP guidelines. Given the high-stakes environment of clinical research and regulatory approval, quality control has been embedded into all of our clinical biomarker services, from beginning to end.
Bioanalytical method validation also requires a detailed appreciation for the complexities associated with patient samples, such as diverse molecular composition and sample variations found across a cohort. Building upon past experience, Element’s clinical biomarker services team circumvents challenges commonly associated with using a bioanalytical assay on patient samples, as they are adept at optimizing approaches for sample collection, stabilization, and extraction techniques for individual biological matrices, biomarkers, and drugs.
We recognize the frustration associated with difficult method transfer processes. Element takes this essential task seriously, and we consider effective method transfer as an essential component for making our work actionable. Therefore, our team works diligently to ensure information is transferred properly, ensuring long-term success.
High throughput bioanalysis
Element is committed to successfully meeting the needs of our customers by delivering accurate, high-quality results in a quick and efficient matter, enabled by our industry-leading, experienced teams of scientists and purpose-built labs. In addition to custom biomarker assay services and bioanalytical method validation, we can apply a previously established method, or one that has been developed by our industry-leading scientists, to execute sample analysis for both preclinical and clinical research.
We understand that scientific teams sometimes do not have the bandwidth to manage an influx of sample bioanalysis, in addition to their existing responsibilities. To support your work without sacrificing precious time, Element’s bioanalytical laboratory can act as an extension of your team, applying their world-class expertise to quickly and carefully analyze samples using the preferred bioanalytical method.
While Element’s bioanalytical lab can use your existing methods or develop new ones to perform experimentation for a variety of drug and biomarker studies, customers also have access to off-the-shelf solutions for dosing formulation analysis, quantitative analysis of biomarkers and drugs in biological matrices, and interference testing, as well as toxicity and clearance. As a result, we can perform a number of analyses swiftly without sacrificing data quality, offering tremendous benefits in terms of accelerated turnaround times.
The Element advantage
When you partner with Element for bioanalysis, you will have direct access to a collaborative team of highly skilled scientists and a suite of advanced analytical platforms including ddPCR and LC-MS bioanalysis, including Orbitrap QExactive and other systems. Our teams work tirelessly to ensure work is done efficiently, accurately, and to the highest performance and regulatory standards. Whether you are working with a well-established biomarker or a novel one, Element’s biomarker services can support all aspects of bioanalytical method development and bioanalytical method validation, through to clinical trial support.
Identify, optimize, and execute the optimal approach to meet your clinical bioanalysis needs. For more information about our bioanalysis and clinical biomarker support services or to request a quote, contact us today.
More from Element
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.