AIT Bioscience provides expert bioanalytical assay support for large and small molecule therapeutics from discovery to IND and through clinical trials. Services include PK/TK, Immunogenicity (Anti-Drug Antibody), Neutralizing Antibody, and Biomarker assay development, validation, and sample analysis. Combining LC-MS/MS and Ligand Binding Assay capabilities to solve the complex assay challenges for large molecule therapeutics. Using an FDA inspected and fully integrated ELN quality system allows us to deliver QA'd data weeks ahead of industry standard timelines.
Product Name: Immunogenicity Assays
Product Description: Using a statistical based approach to assay design and cut-point determination, AITB develops and validates Immunogenicity (ADA) assays tailored to your molecule, phase of development, and therapeutic area.