Reduced Molecular Weight

Reduced molecular weight determination of antibody drugs is essential to ensure the quality, efficacy and safety of monoclonal antibodies. At Creative Proteomics, we focus on providing cutting-edge solutions for the pharmaceutical industry. Our talented scientists will help our clients delve into the content and methods of reduced molecular weight assays and explain how our services can benefit your antibody drug development process.

Introduction to Reduced Molecular Weight Determination

Reduced molecular weight assays play a crucial role in the development and characterization of antibody drugs. Antibodies are large molecules that consist of two heavy chains and two light chains, resulting in a complex structure. Antibodies can undergo various structural modifications during manufacturing processes, such as aggregation, fragmentation, or chemical modifications, all of which can significantly impact the functions and properties of the therapeutic antibody. By implementing reduced molecular weight assays, scientists can evaluate the integrity and purity of antibody drugs. Therefore, it is vital to monitor and analyze the reduced molecular weight of antibody products to ensure their stability, potency, and safety.

Reduced Molecular Weight Determination Methods and Procedures

Our expert team strictly follows the International Harmonization Conference (ICH) guideline Q6B(3) for the detection of reduced molecular weight of antibody drugs. We utilize state-of-the-art instrumentation and employ advanced techniques including sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), size exclusion chromatography (SEC), and high-performance liquid chromatography (HPLC).

Before starting the assay, we carefully prepare the sample by reducing and denaturing the antibody, which helps to equalize the antibody structure and isolate subunits for accurate analysis. Next, the reduced antibody samples are loaded onto SDS-PAGE gels or subjected to SEC/HPLC to separate antibody subunits based on their molecular weight. Finally, we analyze the data obtained, compare it to a reference standard, and provide a comprehensive report on the molecular weight profile of your antibody drug.

Advantages of Our Services

• Accurate assays: Our advanced assays provide a means to accurately determine the reduced molecular weight of antibody drugs, allowing effective monitoring of drug quality and batch-to-batch consistency.
• Sensitive and reliable assays: We offer a highly sensitive and reliable reduced molecular weight assay that detects small changes in the structure of antibody drugs, effectively ensuring accurate and reproducible results that guide the development and optimization of antibody drug formulations.
• Comprehensive analysis: These assays can detect and quantify any modifications or alterations in the molecular weight of the antibody drug, such as glycosylation or truncation, allowing for a comprehensive analysis of the drug variant.

Reduced molecular weight determination have become an important tool for antibody drug development, characterization and quality control. Creative Proteomics offers cutting-edge solutions in the field of antibody drug characterization. Contact us to learn more about reduced molecular weight determination service for antibody drugs. We will be happy to assist you.