Cubis® II in the Context of Therapeutic Antibodies
Last updated: October 2020
Overview
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.
- Document type: Application Highlight
- Page count: 4
- Read time: 5 minutes
Key Takeaways
- 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
- Physical instabilities caused by variables such as temperature, pH-value or UV light can lead to aggregation, denaturation or fragmentation of therapeutic antibodies
- The Cubis® MCA software automates weight calculations, reducing human error in solution preparation
- It ensures compliance with USP Chapter <129>, meeting strict regulatory standards for antibody analysis
- The guided preparation process streamlines lab workflows, saving time and increasing efficiency
- Comprehensive GLP reporting provides full traceability for quality control and facilitates audits
This Resource is Designed for:
- Lab Managers
- Lab Technicians
- Scientists
- Lab Assistants
- Quality Control Managers
- Pharmaceutical Labs
- Life Science Labs
- Chemistry Labs
Applications Supported:
- Analytical Procedure
- Antibody Analysis
- Cubis® II Balances
- Monoclonal Antibodies
- Buffer Preparation
- Sample Preparation
