Pharmbiotest bioanalytical laboratory provides services of quantifying ultra low concentrations of small and medium-sized organic molecules in biological samples in the course of preclinical and/or clinical pharmacokinetic trials, including bioequivalence and bioavailability studies.
Bioanalytical laboratory has metrological certification to provide these measurements.
Analytical equipment, used in the Lab, is internally and externally qualified and it is regularly verified by metrological service. The Lab is equipped with modern tools including HPLC-instruments and mass-spectrometer detectors from Shimadzu and AB Sciex, as well as other analytical ware from world-leader producers.
HPLC is one of the most versatile techniques and essential analytical tool affording separation and quantification of a variety of organic molecules. The tandem MS/MS detector allows selecting certain ions or ion fragments and permits to analyze samples in a minute or less.
Samples storage room is equipped with ultra-low temperature freezers with total volume up to 1000 liters and temperature from -20 ºС to -86 ºС. Monitoring system with automatic emergency alert and twenty-four-hour control of freezers status guarantees the maintenance of the low-temperature regimen.
The Bioanalytical laboratory staff consists of a highly-trained and experienced team of professionals. Our senior management team, with an average of over 20 years of experience and their younger colleagues have significant experience in developing, validation and operating analytical methods for wide range of active pharmaceutical ingredients, drug products, fixed dose combinations and excipients.
For confirming compliance of the Bioanalytical laboratory work-processes with GLP principles, other regulatory documents and standard operating procedures (SOPs) scheduled internal and external audits are conducted to monitor proper quality and improve processes and procedures performance.
We specialize in the development of methods for:
- bioanalytical part of clinical studies;
- identification of active ingredients of medicinal product by comparing their mass-spectrum with mass-spectrum of corresponding pharmacopoeia standard samples;
- monitoring of impurities of active pharmaceutical ingredients on ppm level.
In plans for development of the Bioanalytical laboratory there are increasing the number of LC-MS/MS systems and supplementary analytic equipment, employees’ qualification growth, implementation of proteomic technologies and utilize the LC-MS/MS technologies for diseases biomarker determination and therapeutic drug monitoring.