Experts in pre-clinical bioanalysis
Your compound is moving towards pre-clinical development and you need robust and validated assays to claim Good Laboratory Practice (GLP) for the pre-clinical safety studies. Good news, you’re in the right place. We offer a fully GLP compliant pre-clinical bioanalysis service to support your drug molecule as it enters the pre-clinical development phase of the drug discovery process.
Our process to provide this support includes the following stages:
- Method development
- Method validation
- Stability testing
- Sample analysis
Our team have a wealth of experience in developing bioanalytical methods to support your pre-clinical development projects. Our focus is to have a robust approach to method development to ensure that once developed, our assays will pass all the validation criteria expected from the FDA or EMA regulatory authorities. Our state of the art technology allows us to develop assays bespoke to the needs of your project’s requirements, including ultra-sensitive limit of quantification levels where required.
Method validation that’s robust, accurate and precise and meets current FDA /EMA guidelines
Our method validation studies follow the FDA and EMA regulatory guidelines for the conduct of bioanalytical validations. The validation study is designed to confirm the robustness, accuracy and precision of the assay, in addition to checking the integrity of samples and solutions when subjected to specific conditions in the laboratory:
- Matrix effects
- Linearity and range
- Lower limit of quantitation (LLOQ)
- Upper limit of quantitation (ULOQ)
- Stability evaluations (stock solution, freeze/thaw, short term matrix stability, whole blood stability and post-processed sample stability)
- Effect of haemolysed samples
Our validations are conducted according to the principle of GLP and where required can claim formal compliance to GLP regulations.
Sample storage stability
We can set up storage stability studies to establish the long term stability of your biological samples in nominal storage conditions of -20°C or -80°C. The storage stability duration evaluated can be designed to your own specifications; sometimes we only need to evaluate the effect on samples stored for up to one month or any period up to 2 years. Whatever is appropriate for your project, we can design the right storage stability study.
Regulatory pre-clinical sample analysis
Your samples will be stored in our secure monitored storage facility (-20°C or -80°C) until analysis.
The quality of the data produced during the sample analysis will be monitored by pre-defined acceptance criteria. Certain studies will require Incurred Sample reanalysis (ISR). This is where we repeat certain samples more than once to demonstrate the reproducibility of results from samples produced in the in-vivo model.
You’ll also be surprised by how fast we can turnaround your sample analysis to help with critical decision steps – our robust methods mean we can respond to the most demanding of deadlines.
Sample analysis is conducted according to the principle of GLP and where required can claim formal compliance to GLP regulations.
Data analysis and reporting
All our data is Quality Control (QC) checked during production and inspected by our in-house Quality Assurance (QA) team where the study is claiming GLP compliance.
We provide formal reports for our studies, using your own template or our in-house templates, whichever you prefer.