At AxisPharm, we specialize in developing and validating robust bioanalytical methods to ensure reliable data for your drug development needs. Our tailored approach leverages advanced platforms such as LC/MS/MS, LC/HRMS, ligand binding assays, automated ELISA systems, RIA, Flow Cytometry Assays, and qPCR, ensuring each method meets the highest standards of specificity, precision, and accuracy.

A. Method DevelopmentBioanalytical-Method-Development-and-Validation

Bioanalytical method development is a crucial step for both small and large molecules, ensuring the design, operating conditions, limitations, and suitability of a method before it is optimized for validation. Method development identifies the best procedures and conditions for extracting and detecting analytes and their metabolites, recognizing that each technique has unique characteristics that vary from analyte to analyte.

  1. Analytical Technique Selection: Choose the right technique based on the analyte, sample matrix, and required sensitivity.
  2. Sample Preparation: Extract, isolate, and purify the analyte to minimize interference and maximize recovery.
  3. Instrumentation Optimization: Fine-tune chromatographic and mass spectrometric settings for peak performance.
  4. Calibration Standards: Set concentration ranges that match expected analyte levels.
  5. Quality Control Samples: Define levels to ensure precision and accuracy.
  6. Method Optimization: Iteratively adjust parameters for optimal sensitivity, selectivity, linearity, and robustness.

B. Method Validation

It is essential to use well-characterized, fully validated bioanalytical methods to ensure reliable results that inform critical go/no-go decisions during drug development. Each method is validated according to applicable health agency guidance documents, ensuring it is fit for the intended purpose of the study and produces robust data for specificity, precision, and accuracy.

  1. Specificity: Verify the method detects and quantifies the analyte amid potential interferences.
  2. Linearity: Evaluate the relationship between analyte concentration and instrument response.
  3. Accuracy: Compare measured values against true values using reference methods or standards.
  4. Precision: Assess repeatability (intra-day) and consistency (inter-day).
  5. Recovery: Measure the efficiency of analyte recovery from the biological matrix.
  6. Sensitivity: Determine the limits of detection (LOD) and quantification (LOQ).
  7. Stability: Check analyte stability under various conditions.
  8. Matrix Effects: Evaluate and mitigate the impact of the sample matrix on analyte measurement.
  9. Carryover: Ensure no residual effects from previous samples impact measurements.

C. Documentation

  • Comprehensive documentation of development and validation protocols, including experimental procedures and calculations.
  • A validation report that details results, conclusions, and any recommendations for improvement.

D. Regulatory Compliance

  • Adherence to relevant regulatory guidelines (e.g., FDA, EMA, ICH) and industry best practices throughout development and validation.
  • Support for regulatory submissions with validated methods tailored to your specific study needs.

Why Choose AxisPharm?

Our expertise in developing and validating bioanalytical methods ensures robust and reliable data for drug analytes, metabolites, and biomarkers. With well-characterized, fully validated methods, we provide the confidence needed to make critical decisions throughout the drug development journey.

Contact Us

Contact AxisPharm to discuss your bioanalytical method development and validation needs. Our tailored, compliant services deliver reliable results to support your research and regulatory objectives.

Ref:

Bioanalytical Method Validation Guidance for Industry

ICH Q14: Analytical Method Development Q2(R2)

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