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Large Molecule Bioanalysis

Advancing your Biotherapies to Market

WuXi AppTec offers comprehensive capabilities and sophisticated technology platform in the global pharmaceutical industry. You’ll work with a team of experts who are at the forefront of analytical testing for the next generation of biotherapeutics – and dedicated to clearing a path to more efficiently advance your biotherapies to market.

WuXi AppTec’s bioanalytical team has the experience and expertise to help you move your drug candidate to the next milestone. We’ll customize a program that meets the evolving needs of your project, from study design to regulatory submission.

Download our Large Molecule Bioanalysis Brochure

Your ability to make intelligent, informed decisions hinges on having the right bioanalytical strategy. We can help you develop an approach that will take you from discovery through preclinical to IND and beyond – with leading efficiency and speed.

Industry-Leading Services for Your Drug Development Journey

drug development journey map

Track Record of Experience

Supporting You from Preclinical through New Drug Application

  • Pharmacokinetics (PK) Bioanalytical Services
  • Toxicokinetics (TK) Bioanalytical Services
  • Immunogenicity ADA and Neutralizing Antibody (NAb) Service
  • Statistical analysis of Cut-Point and Low Positive Control determination
  • Exploratory and decision-making biomarker screening/discovery: Ligand Binding Assay (LBA) and LC-MS/MS Services
  • Monoclonal and Polyclonal Reagent Generation

Immunogenicity Bioanalytical Services (GLP)

Biotherapeutics present many challenges in drug development. One is that they are more likely to trigger the immune system when compared to small molecule drugs, which can lead to unwanted effects. Regulatory agencies require extensive immunogenicity testing, and neglecting this vital element of your Investigational New Drug (IND) package can lead to clinical delays. WuXi AppTec collaborates with you to develop custom reagents and assays that analyze key measures of the immune response, along with expert support in executing the multi-tiered testing that adheres to U.S. Food and Drug Administration (FDA) immunogenicity guidelines.

Screening, Confirmatory and Titer Determination Process

Screening, Confirmatory and Titer Determination Process

  • Reagent generation to fit biological therapeutic using monoclonal or polyclonal antibodies for positive controls and epitope-specific reagent purification
  • Anti-drug antibody (ADA) electrochemiluminescent (ECL) bridging assays with capabilities of executing complex assays for difficult biotherapeutics
  • Statistical analysis of cut-point and low positive controls in U.S. FDA-acceptable report format
  • Non-cell-based neutralizing antibody (NAb) assays
  • High drug tolerance with bead extraction and acid dissociation (BEAD)
  • Cell-based neutralizing antibody assays

Navigating the Immunogenicity Assessment