Custom Method Development
Rigorous Quality Control
Absolute Quantitation for Your Specific Research Objectives
Metabolomics is a powerful tool for understanding biological systems and advancing disease treatments. Targeted panels—which provide absolute quantification on a subset of metabolites of interest—can answer specific research questions, uncover actionable insights, and propel new therapeutic developments. Sometimes, a targeted metabolomics panel may not exactly fit your analyte requirements: you may wish to analyze a non-validated matrix with greater confidence or prefer a narrower metabolite focus than what the available panel provides.
Customers interested in a bespoke list of analytes or who are working with unique samples or low analyte concentration can benefit from Metabolon’s Custom Method Development services for absolute quantification, allowing you to get the specific information you need without compromise—all while preserving the same advantages offered by Metabolon’s Targeted Panels.
Benefits of Custom Method Development
Accurate and reproducible measurements of a number of analytes or even a single analyte can be difficult, particularly if those analytes are present in low concentrations in a sample. With Metabolon’s Custom Method Development, you can rely on our experience to develop a new and customized method to meet your needs. Custom Targeted Panels and Single Analyte Assays can be developed and validated in practically any matrix. With custom offerings, sample preparation methods can be altered and different mass spectrometers can be leveraged to increase sensitivity, maximizing the detection and sensitivity of your analytes even when working with limited sample volumes.
These customized offerings enable investigators to answer specific research questions, uncover actional insights, and propel new therapeutic development, including novel diagnostic tests, using limited sample volumes, volatile analytes, and matrices that aren’t validated on existing commercial panels. Many of our customers are investigators and clinicians that use Custom Targeted Panels or Single Analyte Assays to inform clinical trial decision-making. When it comes time, regulatory submissions are easy because Metabolon’s methods can be designed for GCP-compliance, validated to FDA and EMA standards, and processed according to GCP/GCLP standards.
Delivering Absolute Quantification for Research and Biomarker Analysis
Our readily available or custom developed quantitative assays help you achieve your research and biomarker validation objectives with precise and fully validated methods. Our targeted assays and panels cover >1,000 metabolites and lipids across a wide range of biochemical classes, metabolic pathways, and physiological processes, and they can be customized to best fit any application.
Sample Matrix Validation Details
Our Quality—ISO 9001:2015-certified Laboratory
Mtabolon offers three levels of sample validation: Exploratory (research-oriented, limited validation), RUO (Research Use Only), and GCP/GCLP (Good Clinical Practice / Good Clinical Laboratory Practice).
All methods at Metabolon are validated to adhere to Metabolon’s ISO 9001:2015-certified quality system. Validation experiments are based on the FDA, EMA, and ICH M10 Bioanalytical Guidance documents. All data are peer-reviewed, and a summary report containing the results of the validation experiment is provided.
For GCP/GCLP validation, all experiments and acceptance criteria strictly adhere to the FDA, EMA, and ICH M10 Bioanalytical Guidances. All GCP/GCLP studies are peer-reviewed and audited by the Metabolon Quality Assurance Department. A validation report containing all of the elements listed in the M10 Bioanalytical Guidance is provided.
The table below outlines all evaluated analytical performance parameters for Exploratory, RUO, and GCP/GCLP standards.
Swipe left/right to view the full table.
|Method Development Offerings|
|Linearity, Accuracy, and Precision of Calibration Standards||✓ (1 run)||✓ (3 runs)||✓ (3 runs)|
|QC Precision Accuracy||✓ (one level, precision only)||✓ (3 levels)||✓ (3 levels)|
|Lower Limit of Quantitation||✓ (1 run)||✓ (3 runs)||✓ (3 runs)|
|Selectivity||✓ (1 run)||✓ (3 runs)||✓ (3 runs)|
|Carryover||✓ (1 run)||✓ (3 runs)||✓ (3 runs)|
|Extraction Recovery (also used to show accuracy)||✕||✓||✓|
|Sample Stability Testing—Benchtop Stability||✕||✓||✓|
|Sample Stability Testing—Freeze/Thaw Stability||✕||✓||✓|
|Matrix Effect Testing||✕||✕||✓|
|Sample Stability Testing—Long-Term Stability||✕||✕||✓|
|Extract Stability Testing||✕||✕||✓|
|Run Injection Stability Testing||✕||✕||✓|
|Solution Stability Testing||✕||✕||✓|
Let Us Do The Hard Work For You
We work closely with our customers to develop custom panels purpose-built for their specific research needs. All custom panel projects begin with a one-on-one consultation to learn about our customer’s research program and the knowledge gaps a Single Analyte Assay can fill. We then generate the custom assay and run the samples, delivering the same high-quality customer service and data analysis and interpretation that comes with any project performed with Metabolon.
Achieving absolute quantification for a panel of analytes in a reproducible, cost-effective, and timely manner can be challenging to achieve alone. With our decades of experience, a library of over 5,400 known metabolites, and clinical know-how we’re fully equipped to help you develop an accurate customized panel of analytes or Single Analyte Assay to answer your research question. Only Metabolon can support an investigator through the scientific paradigm of target discovery, interrogating thousands of metabolites with our Global Discovery Panel, through to target validation, using our suite of customizable targeted methods to derive actionable biological insights—all at the cost-effective scale necessary to support our customers’ needs.
Big Insights with Metabolon
Cited in over 3,000 publications, we help scientists and manufacturers gain greater insight into their studies through metabolomics. See how our approach can become a successful part of your workflow.
Related Metabolomics Resources
Talk with an expert
Request a quote for our services, get more information on sample types and handling procedures, request a letter of support, or submit a question about how metabolomics can advance your research.
617 Davis Drive, Suite 100
Morrisville, NC 27560
P.O. Box 110407
Research Triangle Park, NC 27709
+1 (919) 572-1711