GLP- and ICH M10-Compliant Bioanalysis for a Wide Range of Modalities in Nonclinical and Clinical Studies

At every stage of drug development, Sumika Chemical Analysis Service, Ltd. (SCAS) conducts bioanalytical method validation and sample analysis in accordance with GLP and the guideline "ICH M10: Bioanalytical Method Validation and Sample Analysis".

We perform bioanalyses using the latest analytical instruments and methodologies tailored to a wide range of modalities in compliance with global regulations. Our flexible bioanalytical approach leverages LC-MS/MS, ELISA (enzyme-linked immunosorbent assay), ECL (electrochemiluminescence), and other platforms, allowing us to accommodate various study objectives and sample characteristics.

We evaluate validation parameters in accordance with ICH M10. The main validation items are as follows:

• Specificity and selectivity
• Linearity
• Lower limit of quantification (LLOQ)
• Within-run reproducibility
• Between-run reproducibility
• Recovery
• Matrix effect (precision and accuracy)
• Carry-over
• Dilution integrity
• Reinjection reproducibility
• Batch size assessment
• Freeze-thaw stability
• Autosampler stability
• Bench-top (room temperature) stability
• Long-term storage stability
• Whole blood stability
• Reference standard stability

We perform quantitative analyses of drug concentrations in toxicokinetic (TK), pharmacokinetic (PK), and pharmacodynamic (PD) studies after the administration of various modalities. Our services include quantification of anti-drug antibodies (ADA) and endogenous biomarkers in biological samples.
By using ICP-MS, we also conduct elemental analyses of manganese and bismuth in plasma, gadolinium in urine, and platinum in plasma or tissue samples.

• 1.
  GLP (MHW Ordinance No. 21): Ministerial Ordinance on Criteria for the Conducting Nonclinical Studies on Drug Safety
• 2.
  GCP (MHW Ordinance No. 28): Ministerial Ordinance on Criteria for the Conduct of Clinical Trials on Drugs
• 3.
  ICH M10: Guideline on Bioanalytical Method Validation and Study Sample Analysis

We register and manage a wide array of analytical instruments for GLP-compliant studies, including multiple LC-MS/MS systems.

• LC-MS/MS Systems: Triple Quad 6500, Triple Quad 6500+, QTRAP 6500, Triple Quad 7500
• GC-MS/MS System
• ICP-MS
• Other Platforms: ELISA, ECL, SPR (Surface Plasmon Resonance), microplate reader, microbead array, PCR (Polymerase Chain Reaction), and more