Expert Consulting on Large-Molecule Bioanalytical and Immunogenicity Testing
Leverage 40 years experience in pharmacokinetic, anti-drug antibody and biomarker assays for YOUR project
Assay development
Establish bioanalytical strategy, identify appropriate assay formats, source critical reagents, optimize and customize for YOUR applications.
Regulatory Compliance
Ensure your assays meet regulatory and quality requirements. Assay qualification and validation. Oversight of CRO laboratories.
Assay Data Analysis
Set ADA cut points. Assess validation parameters. Calculate quality control ranges. Validation and Sample Analysis Reports.