Bioanalytical section
FCRL houses a fully GLP-compliant bioanalytical facility that is spread over 4500 sq. ft. with state-of-the-art infrastructure managed by qualified and trained scientists from varied fields of chemistry, analytical chemistry, biological sciences, pharmacokinetics, instrumentation and pharmacology. The combined diversity of backgrounds and experience gives us unique capabilities in the development of highly sensitive and robust assays.
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The details of the bioanalytical infrastructure are as follows:
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Sample processing labs with provision to handle light-sensitive drugs |
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Instrument lab with HPLCs (Shimadzu) with UV and florescence detectors |
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Instrument lab with LC/MS/MS machines (Sciex API 3000) |
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Balance alcove (with anti vibration tables and analytical, top-loading & micro balance) |
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Sample store (with a -20°C walk-in cold room and -80°C deep freezers) |
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Validated Computerized Temperature and Humidity Monitoring System - Eurotherm |
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Validated and 21 CFR part-11 compliant chromatographic software systems with complete data back-up facilities |
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UPS (Uninterrupted Power Supply) and generator back-up |
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Method development and validation according to FDA, EU, ANVISA and ICH requirements |
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Varying extraction techniques including solid-phase |
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Study sample analysis in all types of biological matrices |
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Metabolite analysis |
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Analysis of multiple analytes from combination drug products |
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Adaption and re-validation of client assay methods |
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