Protein A Residue Analysis
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Detection of protein A residues in antibody formulations purified from protein A purification columns is a critical quality control step in the production of antibody drug formulations. Creative Proteomics offers comprehensive residual protein A testing service for antibody drugs to ensure your product meets stringent quality requirements. Our state-of-the-art laboratory, equipped with advanced technology, performs highly sensitive and precise quantification testing to detect even minute amounts of residual protein A.
Introduction of Protein A Detection
The advancement of biotechnology has opened up possibilities for the development of therapeutic antibodies for various medical applications. Among the various antibody purification methods, the use of bacterial protein A is one of the most commonly used due to its high affinity to bind the Fc region of IgG-type antibodies. However, this purification process may leave residual protein A molecules attached to the antibodies, which may cause immunogenic reactions or interfere with the performance of the antibody drug. Protein A residues in the product can cause adverse immune response reactions, and its complexes with antibodies can activate the immune response of Fc-carrying leukocytes and the complement system in vivo, resulting in oxidative and allergic reactions. Hence, the need for a precise protein A residue testing service in the antibody drug manufacturing process is necessary to ensure the safety and efficacy of these drugs.
Our Protein A Residue Analysis Service
We provide a comprehensive antibody drug residue protein A detection and analysis service that is specifically designed to quantitively analyze and detect residual protein A in antibody drugs. Our services include sample preparation, extraction of protein A, quantification, detection, and comprehensive reporting of the findings. We also offer consultation services to discuss the results and provide recommendations.
We begin the process by preparing the sample. The sample is purified and then treated, most often through denaturing and reduction methods.
The protein A extraction is then carried out using specialized methods, often involving chromatography, affinity purification procedure or peptide mapping.
After the extraction, quantification is done using state-of-the-art instruments and technologies such as Enzyme-Linked Immunosorbent Assay (ELISA), Mass Spectrometry (MS) or Liquid Chromatography (LC). Apart from these, residual protein A is also detected through immunological methods, Western Blot, or SDS-PAGE.
The analysis is performed to study the properties and concentrations of protein A. Bioinformatics tools might be used to accurately analyze and predict the potential impact of interactions and structural modifications.
Service Features
- High sensitivity for accurate detection of even trace amounts of protein A.
- High accuracy of results, recognizing a wide range of different structures of Protein A.
- High throughput, with results for multiple samples available in a short period of time.
- Cost-effective for the detection of different protein A variants in monoclonal antibody preparations.
Creative Proteomics offers biopharmaceutical companies the assurance of minimizing any residual Protein A that may induce unwanted immune responses in patients. By integrating this testing service, drug manufacturers can ensure that their products meet regulatory requirements for purity and safety, leading to better patient outcomes. For more information or to request our services, please feel free to contact us.
