 |
 |
Discovery Bioanalysis
Why We Are Different
Philosophy
Agilux Laboratories was founded specifically to meet the needs of clients outsourcing discovery (non-GLP) bioanalysis. Instead of stripping down GLP assays, we started with the unique needs of discovery programs: the need to get reliable data (good enough to answer the question), the need to be flexible and responsive in our approaches to getting the data, and the need to get that data to you fast.
Timelines
Agilux fully understands and is committed to providing the services demanded by the speed requirements of discovery. We have built our processes and operations around the need for speed, enabling us with no prior notice to consistently deliver to you quality data supporting studies of many designs and complexities in 2-5 days or less.
The benefit to you of this unique service - Better Data Faster.
Discovery 2.0™
From our decades of experience, we designed the processes and procedures of Agilux to address the unmet needs unique to discovery bioanalysis. We call this Discovery 2.0. The principal components of Discovery 2.0 are found in the use of:
- Our Approach to starting conditions
- The definitions of the Research Grade Assays (RGAs)
- The companion Diagnostic Probes.
The RGAs define the level of analytical rigor appropriate to meet the data quality needs of the study. The Probes are embedded diagnostic tests that assess various aspects of the sample analysis as performed on the study samples.
For more information on our Discovery Bioanalytical services, please see the details below and contact us at info@agiluxlabs.com.
View the Discovery Bioanalysis Product Sheet.
Expand All
Our Approach
In discovery bioanalysis, the lab is often blind to analyte structure. In order to proceed quickly and intelligently, we start with a generic protein precipitation LC-MS/MS method that is applicable to the vast majority of small molecule compounds, eliminating the need for method development or qualification. Features of the methodology include:
- Assay range of 1-5000 ng/mL (default; can be modified as required)
- Front and back calibration standards consisting of 9 different concentrations
- Sample aliquot volume 10 µL (particularly important for e.g., serial mouse sampling)
The use of bracketing calibration standards is crucial in discovery to control potential divergence (drift) that can occur due to buildup of matrix components or dosing vehicle. This effort is further aided by our use small sample volumes, which minimize these adverse effects, plus our use of the latest technologies such as UPLC and API 5500 to achieve appropriate sensitivity even with such small sample aliquots.
The key to balancing the competing demands of data quality, speed of execution, and cost is an understanding of the data quality required to satisfy experimental objectives. Agilux offers a suite of standardized, fit-for-purpose non-GLP Research Grade Assays (RGAs; see detail in specification below) to address client needs across the drug discovery continuum. Additionally, for studies assessing multiple matrices, we can flexibly work with you on alternative assay scenarios to effectively manage cost and minimize time while ultimately satisfying data quality requirements. Likewise, Agilux Laboratories can perform studies using client defined procedures and acceptance criteria to ensure data comparability, consistent with our philosophy of providing services as a true extension of your internal capabilities and processes.
Experience has taught us that great design must be followed by great execution. To ensure this, we have designed a number of diagnostic probes embedded into our sample analysis to assess – and demonstrate – that high quality data are produced. The Probes are further used to identify, diagnose, and troubleshoot areas where data quality may be compromised, enabling us to solve problems and re-establish quality quickly. Examples of the Probes include:
- Multiple internal standards (options to accommodate a range of retention times and to assess suppression)
- Multiple transitions for each analyte
- Injection Standards (added post extraction similar to System Suitability standard)
- Calibration Probe (determine correct preparation of calibration standards)
- Dilution Probe (determine that sample dilution was performed correctly)
- Matrix Effect Probe (determine if matrix or vehicle may be causing quantitation interferences)