Cyprotex offer advanced bioanalytical method development under our portfolio of services. Our state of the art instrumentation, in combination with our experienced bioanalytical scientists, provides a superior, high quality service.
Bioanalysis is a term generally used to describe the quantitative measurement of a compound (drug) or their metabolite in biological fluids, primarily blood, plasma, serum, urine or tissue extracts.
1Pandey S, et al., (2010) Pharm Methods 1(1); 14-24
All our LC-MS/MS systems are protected by an uninterrupted power supply system ensuring power input fluctuations are smoothed out/reduced and the systems are supported by a limited battery backup power supply in case of mains power failure.
Bioanalytical Method Development Service |
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Understanding the chemistry of your compound is important for designing the method development studies. The service consists of 3 main steps: Step 1: MS/MS optimization (if preferred method of detection is mass spectrometry) |
Advanced Bioanalytical Method Development Service |
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Our advanced bioanalytical method development service is a non-GLP service which can evaluate any of the following parameters to assess robustness of the bioanalytical method. These parameters can be tailored based on customer requirements.
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Data are presented in a written report. Example reports are available on request. |
How would you approach a bioanalytical method development study?
Cyprotex feel that it is important to work closely with clients for these studies. It is vital to identify specific customer requirements or issues prior to initiating the work. For example, the customer may have a need to detect compounds at a particular level for future routine studies or they may be aware of specific issues such as light sensitivity or stability. It is beneficial to have as much information as possible from the customer regarding the compound e.g., structure, physicochemical properties or previously developed methods. This will help us to identify the optimal conditions with respect to chromatographic columns and mobile phase gradients.
Method development is performed in 4 phases. The client will be consulted at each stage of the process.
Describe the advanced bioanalytical method development procedure.
This may evaluate linearity and sensitivity, accuracy and precision, inter and intra batch variability, selectivity, matrix effects and stability. The process can be customized depending on specific customer requirements.
How are data reported to the customer?
For the method development studies, details of the protocol for the bioanalytical method along with any supporting data generated during the development process is presented as a written report.
Example reports are available on request.
Do you offer this service to GLP?
Although these studies are not performed to GLP they are able to follow the relevant aspects of the current regulatory guidance;
FDA Guidance for Industry for Bioanalytical Method Validation (May 2018)2.
EMA Guideline on Bioanalytical Method Validation which came into effect in February 20123.
1 Pandey S, et al. (2010) Bioanalysis in drug discovery and development. Pharm Methods 1(1); 14-24
2 FDA Guidance for Industry for Bioanalytical Method Validation (May 2018)
3 EMA Guideline on Bioanalytical Method Validation (Feb 2012)
Telephone:
Europe: +44 (0)1625 505100
North America (East Coast): +1-888-297-7683
Email:
info@evotec.eu