Application Highlight: Reliable, Consistent and Traceable Preparation of Buffers and Solutions for Antibody Analysis

Antibodies are subject to various issues due to chemical and physical instabilities. These effects may change the pharmacokinetics of antibodies (e.g. due to loss of antigen binding activity, impaired resorption or degradation by proteases). Because of these potential instabilities, pharmacopeias dictate produced antibodies must be thoroughly tested before they can be applied for treatment of patients.  

US Pharmacopeia Chapter 129 lists several analysis methods for therapeutic antibodies, including size-exclusion chromatography (SEC) and liquid chromatography (LC) with fluorescence detection. Each of these methods require the preparation of buffers and solutions, many of which require the precise weighing of multiple components.  

Download this application highlight to learn about the relationship between therapeutic antibodies and analytical balances – and how Cubis® II can streamline the testing process. 

Commonly Asked Questions:  

  • Which chemical instabilities affect therapeutic antibodies?
      
    • Oxidation, disulfide bond formation, glycation and deamidation are the most frequent chemical instabilities and are caused by oxidants like peroxidases, light or metals, or by sugars via the Maillard reaction.  
  • How do physical instabilities affect therapeutic antibodies? 
     
    • Physical instabilities caused by variables such as temperature, pH-value or UV light can lead to aggregation, denaturation or fragmentation.

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