Large Molecule Bioanalysis

Advance your Effective Biotherapies to Market

WuXi AppTec provides you with the most comprehensive capability and technology platform in the global pharmaceutical and healthcare industry to fulfill the dream that every drug can be made and every disease can be treated.

You have access to a Large Molecule Bioanalytical team of experts at the forefront of analytical testing for the next generation of biotherapeutics. Our team will help you gain the accurate information that is needed to advance your candidate from preclinical to clinical development quickly and safely. We are passionate about your program and in maximizing the successful regulatory submission rate of our customers. Our team is dedicated to improving efficiencies and clearing a better path to advance your effective biotherapies to market.

Download our Large Molecule Bioanalysis Brochure

WuXi AppTec’s vision is to become the most comprehensive capability and technology platform in the global pharmaceutical and healthcare industry to fulfill the dream that every drug can be made and every disease can be treated.

Industry-Leading Services for Your Drug Development Journey

drug development journey map

Track Record of Experience

Service Support: Preclinical Through New Drug Application (NDA)/Biologics License Application (BLA) (Non-GLP/GLP)

  • 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.
  • Reagent Generation Polyclonal and Monoclonal

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

Provided Services: 

  • 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 with 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 Through the Immunogenicity Assessment