One-dimensional protein electrophoresis techniques such as SDS-PAGE are routinely used in laboratories, but the reality is that they are insufficient to analyze various proteins with low resolution. Protein 2-D gel electrophoresis (2DE) is a method to compare and analyze hundreds or thousands of proteins simultaneously by separating various proteins by their pI values ​​and molecular weights. When used in conjunction with a variety of analytical software, immunodetection techniques, and mass spectrometry techniques, these techniques can be used as powerful tools to aid in high-resolution protein analysis.

Auto2D^® Protein 2d electrophoresis automation device

It is known that protein two-dimensional electrophoresis is usually time-consuming and because of its low reproducibility, data misinterpretation by the experimenter is easy, so advanced user training and user experience are important. Auto2D^® system is a device that can automate 2d protein electrophoresis. 

First, the sample enters into a one-dimensional gel to be separated according to its isoelectric point and is separated, and then is separated again in two dimensions on an SDS-PAGE gel by molecular weight. Auto2D^® The system is user-friendly and allows 2-D  electrophoresis by reducing the experimental time from the previous 4-24 hours to 1-2 hours, resulting in faster and more reproducible results. Auto2D^® also has additional features and benefits as follow.

• Easy to use, no advanced training required
• Implement rapid workflows to reduce experiment time
• Reduced variability between measurement systems and high reproducibility
• IQ/OQ support for GMP compliance

Measurement of residual HCP (host cell protein) in biopharmaceuticals

Protein two-dimensional electrophoresis can also be used to measure HCP (host cell protein) in the production of therapeutic proteins and new antibody drugs. HCP remaining in the manufacturing process of biopharmaceuticals may act as an impurity, causing an immunogenic reaction in patients and reducing the efficacy of the drug. Regulatory compliance requires monitoring and removal of HCPs to an acceptable low level to ensure safety. Pharmaceutical companies in Japan, Europe and the United States have guidelines for the development and validation of HCP tests for biopharmaceutical manufacturing.

ELISA is the most common test method for HCP analysis. This immunoassay uses polyclonal Abs that recognize residual HCPs with broad coverage. Pharmaceutical companies in Japan and Europe specify that 2-D protein electrophoresis followed by western blot analysis is used to evaluate HCP antibody coverage. American pharmaceutical companies stipulate that protein 2-D electrophoresis and western blot analysis or gel electrophoresis after immunoaffinity purification should be used to evaluate antibody coverags.