Bioanalytical

Bioanalysis is a specialized branch of analytical chemistry that aims to quantify the concentration of a drug, metabolite, or biomarker in a biological matrix such as blood, serum, plasma, urine, or tissue samples.

For small molecules drugs, method development involves selecting an appropriate sample preparation technique to isolate the drug or metabolite of interest from the biological matrix.

For Biologics, the bioanalytical assays must be highly selective to avoid cross-reactivity with endogenous substances or other analytes in the sample matrix. We use an array of strategies starting from Ligand binding assays (LBAs) such as ELISA, LC-MS/MS, LC-HRMS, and hybrid LC-MS or immunoaffinity-LC-MS.

Bioanalytical studies are critical in any drug discovery and development program. Studies that require bioanalytical support include bioavailability (BA)/bioequivalence (BE), non-clinical pharmacokinetics (PK)/toxicokinetics (TK), anti-drug antibody assays (ADA), and biomarker evaluation. Guidelines for these studies have been outlined by the FDA, ICH, EMA, and other global regulatory bodies.

Our Total Quality Assurance (TQA) capabilities include proprietary method development, validation, method transfer, high throughput sample analysis, and pharmacokinetic and toxicokinetic support, combined with automated data capture and reporting system. Clinical sample management services are provided for the collection and shipment of samples from clinical study sites.

Recognizing the critical role bioanalysis plays in drug development, our mission is to consistently deliver accurate and reliable data that is subject to rigorous scientific and regulatory review, ensuring the success of your discovery, preclinical, and clinical programs.

• • Method Development
  • Method Validation
  • Lead Optimization Studies
  • Pharmacokinetic (PK) Analysis
  • Bioavailability Studies
  • Bioequivalence Studies
  • Dose Formulation Analysis
  • GCP Bioanalytical Services
  • Bioanalytical Technologies including Liquid Chromatography – Mass Spectrometry, Inductively Coupled Plasma – Mass Spectrometry, Capillary Electrophoresis, and Nuclear Magnetic Resonance Spectroscopy
  • Bioanalysis of PEGylated and other Polymer-Linked Drug Assays
  • Metals And Elemental Bioanalysis by ICP-MS

• Quantitative Bioanalytical LC-MS/MS
• Tissue Bioanalysis

Wake Diagnostics is a world-leading provider of immunochemistry and biomarker services for bioanalytical studies – supporting the preclinical and clinical development of protein-based therapeutics and other biologic medicines.

• Immunochemistry Services
• Quantitative Immunoassays
• Immunogenicity Assays
• Biomarkers Assays
• Cell-Based Neutralization Assays
• Ligand-Binding Assays