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  Services  »  Bioanalytical Services

Bioanalytical Services

Pharmacelsus provides state-of-the-art equipment to obtain the most sensitive bioanalytical method possible.

 

Bioanalytical equipment

State of the art LC-MS/MS instrumentation and optimized analytical methods allow the detection of 10-9 g to 10-12 g amounts in biological matrices. Generally, generic sample preparation methods are used to obtain initial separation of the analytes from matrix components; these methods are refined for individual compounds as indicated by preliminary results. The assays are applicable to samples in any biological matrices and dosing routes and can be customized as requested.

 

Metabolite Characterization according to the FDA guidance for industry, Safety testing of drug metabolites

LC-MS vials

Since each drug is subjected to metabolism when it enters an organism, the resulting metabolites can be toxic or pharmacologically active, just like the origin drug.

As a consequence, the FDA insists on the identification of metabolites and their safety evaluation as described in the guidance for industry, safety testing of drug metabolites, FDA, February 2008. The characterization of metabolites by LC-MS/MS is done routinely by Pharmacelsus.

 

Biomarkers and Immunochemistry (ELISA)

Pharmacelsus offers a large variety of cell-based quantitative ligand-binding assays that include antibodies, growth factors, hormones, cytokines, biomarkers etc..

Here is a list of the services available at Pharmacelsus (PDF)