Antibody Drug Purity Analysis Service
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In the rapidly evolving biopharmaceutical industry, there is a growing demand for sophisticated, reliable, and effective antibody drug purity analysis. As an integral part of the drug development process and subsequent post-market surveillance, drug purity testing is paramount. Ensuring that antibody drugs are devoid of contaminants and meet purity standards is not only vital for successful product development and regulatory approval but, more importantly, for patient safety. Creative Proteomics' analytical services department fully recognizes the importance of antibody drug purity testing. We offer comprehensive, robust, and advanced antibody drug purity analysis services designed to support our clients through every stage of drug development.
Our Antibody Drug Purity Analysis Service
Our antibody drug purity analysis service provides detailed quantification and characterization of different types of antibody drugs, including monoclonal antibodies (mAbs), polyclonal antibodies and antibody drug conjugates (ADCs). The testing process also identifies possible impurities and contaminants, such as residual DNA, host cell proteins, endotoxins, aggregates, and other unwanted components. In addition, our state-of-the-art technology and methods allow for detailed analysis regarding the antibody's structural integrity, stability, aggregation tendency, binding affinity, and more.
Our Purity Analysis Methods
We leverage various analytical techniques such as liquid chromatography (LC), mass spectrometry (MS), and nuclear magnetic resonance (NMR) for conducting our antibody drug purity analysis. Our preferred methodologies include:
| Method |
Description |
| Capillary Electrophoresis Sodium Dodecyl Sulfate (CE-SDS) |
CE-SDS provides several advantages over other methods, such as high resolution, reproducibility, speed, and minimal sample requirements, making it a powerful tool for purity analysis in antibody drug development. This separation allows determination of the relative abundance of various molecular species in the sample, such as aggregated, fragmented, modified or misfolded proteins, thus allowing quantitative purity analysis. |
| Ion Exchange Chromatography (IEX) |
In antibody drug purity analysis, IEX is often employed as it provides highly sensitive information on the charge heterogeneity of the drug. In IEX, these antibody proteins can be separated based on their charge differences. |
| Size-Exclusion Chromatography (SEC) |
Size-Exclusion Chromatography (SEC) is a form of liquid chromatography that separates molecules according to their size. In the context of antibody drug analysis, SEC is used to separate the target antibody from high molecular weight (HMW) species (aggregates and multimers) and low molecular weight (LMW) species (fragments and impurities). After separation, the different species are typically detected by ultraviolet light and quantified. The purity of the target antibody can then be calculated by comparing its amount to the total amount of detected material. |
| Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) |
In terms of antibody drug purity analysis, RP-HPLC is used to provide a detailed molecular profile of the drug substance. It allows the separation and quantification of a drug's components, including the active drug, impurities, degradants, and excipients. |
| Capillary Isoelectric Focusing (cIEF) |
Capillary isoelectric focusing (cIEF) is a powerful high-resolution separation technique used in antibody drug purity testing. This method separates proteins by their isoelectric points (pI), which is the pH at which the net charge of the protein is zero. |
Advantages of Our Antibody Drug Purity Analysis Service
- We strive to craft a well-suited testing protocol depending on the specific demands of our clients.
- Each testing process is conducted under strict Good Laboratory Practice/Good Manufacturing Practice.
- Accurate and efficient testing techniques ensure high-quality and reliability data.
Leveraging our high level of expertise in antibody drug analysis and characterization, Creative Proteomics has applied our experience, industry and regulatory knowledge to build a comprehensive antibody drug purity characterization platform to meet current regulatory expectations. Contact us to learn more about our services. We will be happy to serve you.
