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Bioanalytical Services

We provide support for the drug development process from exploratory stage to post-marketing surveillance stage based on our extensive experience. We are able to conduct various kinds of bioanalytical analyses by LC-MS/MS or ligand binding assay (LBA) using the latest technology and equipment at our GLP-compliant facility, and also we have experience of validation studies of over 100 different analytical methods each year.

Development of analytical methods

Based on chemical structures of drugs or on clients' information, we develop analytical methods by LC-MS/MS or LBA for determination of small molecule drugs, nucleic acid drugs, antibody drugs, anti-drug antibody (ADA), and neutralizing antibody (NAb). We also examine pretreatment methods and analytical conditions of analytical samples.

Validation of analytical methods

We conduct validation studies of the analytical methods according to various regulations and guidelines required by domestic and international authorities. We also examine various validation items (e.g. stability of drugs in blood) for clinical studies.

Determination of drug concentrations in biological matrix

At Analytical Research Center in Shimura, we carry out sample analyses with validated methods by LC-MS/MS or LBA, in accordance with GLP.
We also have ready-made analytical methods by LC-MS/MS for drug-drug interaction studies, and for determination of existing drugs or steroid hormones as shown below.

Ready-made analytical methods by LC-MS/MS for drug-drug interaction studies Ready-made analytical methods by LC-MS/MS for existing drugs Analytical method for 17 steroid hormones

Multi-site studies

At Analytical Research Center in Shimura, we are able to conduct TK analyses as multi-site studies, with the same quality of GLP as toxicity studies performed at Nonclinical Research Center in Kashima and Kumamoto. At Analytical Research Center, analyses of non-clinical samples obtained from the studies conducted at Nonclinical Research Center are available.

Determination of drug concentrations in protein preparations

We conduct the determination of target materials in protein preparations including antibody drugs, and their anti-drug antibodies (ADAs) in biological samples (serum, plasma, etc.) mainly by ligand binding assay (LBA).

Ligand binding assay (LBA)

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