Biomarker Analysis and Assay
Ask us about validated, reliable biomarkers that can be used in your project. We can provide free analysis of markers appropriate for your pathway or set up quantitative assays for your marker of interest.
Analysis of biomarkers in biological samples can dramatically increase your chances of success in ANY drug development program including support for:
– Target identification
– Proof of mechanism
– Proof of concept
– Treatment/safety monitoring
– Outcome measurement
Biomarker analysis can be performed at every stage of drug R&D using serum, plasma, cerebrospinal fluid, urine, tissue culture supernatants, bronchoalveolar lavage, synovial fluid, tissue extracts, tears, skin washings. The samples are examined to analyze patterns of proteins that correlate with progression of disease or therapy (biomarkers). In addition, metabolic and toxicity indicators can be examined. Using this information, Alera Labs provides valuable guidance on the drug candidates that will be more likely to produce a positive response. Our assays can be used in any therapeutic area such as oncology, cardiovascular, inflammation, infectious disease, and most others.
Alera Labs provides customized biomarker assay development services to meet your needs for pre-clinical and clinical trials. We further validate the assay for its sensitivity, specificity, accuracy, reproducibility, and stability. Through assay validation studies, Alera Labs’ scientists can provide you with reliable and accurate results that are scientifically sound and meet FDA and other regulatory directives.
An assay validation study can help you make important decisions to protect the integrity of your trial. You can choose three levels of service that we provide to optimize and validate your assay:
– Proof-of-concept (POC) to verify the feasibility of reagents.
– Quantification to test the validity of biomarkers by using
– method-to-method comparing studies.
– Full-validation to validate assay through standard tests to be applicable, and to support GCP and GLP studies. The validation includes intra- and inter- precision, tech-to-tech comparison, sample stability, sample recovery, linearity etc.
Assay validation studies are focused on assay performance. The validated assay is to ensure that the tested biomarker is linked to a clinical significance to support your Investigative New Drug Application (INDA) and New Drug Application (NDA).
Pharmaceutical, Biotechnology, Medical Devices Industry (HPLC, LC-MS, LC-MS/MS)
Alera Labs is a trusted provider of biomarker analysis and assay services, catering specifically to the pharmaceutical, biotechnology, and medical devices industries. Their expertise encompasses a range of cutting-edge techniques, including High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS).
In the context of HPLC, Alera Labs provides state-of-the-art biomarker analysis, helping to detect and quantify specific molecules that serve as indicators of biological states or conditions. This can be particularly valuable in pharmaceutical development, where biomarkers can be used to monitor drug efficacy and safety during clinical trials. Similarly, in the medical devices industry, biomarker assays can assist in the development and validation of diagnostic tools.
When it comes to LC-MS and LC-MS/MS, Alera Labs excels in leveraging these powerful techniques for biomarker analysis. These techniques are capable of detecting and quantifying a vast array of biomarkers with high sensitivity and specificity. In biotechnology research, for example, these analyses can be used to identify potential therapeutic targets or to monitor the effects of a biologic drug on the body.
For the pharmaceutical industry, Alera Labs’ biomarker assays can be used to guide drug discovery and development. For instance, biomarker levels can be monitored to assess the efficacy of a new drug or to detect potential side effects early in the drug development process.
In the medical devices industry, these analyses can help in the development of diagnostic devices. By identifying specific biomarkers associated with a particular disease or health condition, these devices can provide fast, reliable diagnoses to guide treatment decisions.
Overall, Alera Labs’ biomarker analysis and assay services, leveraging HPLC, LC-MS, and LC-MS/MS techniques, offer vital support to the pharmaceutical, biotechnology, and medical devices industries. These services are instrumental in advancing research, improving product development, and ultimately enhancing patient outcomes.