Impurity Analysis of Antibody Drugs
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Antibody drug impurity analysis is a significant component of the comprehensive characterization of antibody drugs, affecting their safety, effectiveness, regulatory compliance, market competitiveness, and innovation potential. At Creative Proteomics, we offer comprehensive antibody drug impurity analysis services designed to ensure the quality, safety, and efficacy of your biopharmaceutical products. Our skilled and experienced team is dedicated to providing high quality, reliable analyses, helping to pave the path to successful approval and launch of your products.
Why Impurity Analysis of Antibody Drugs is Important?
Antibody drugs are complex biological molecules, and their manufacturing process involves many steps, each of which can introduce potential impurities. These impurities can range from process-related impurities such as host cell proteins, residual DNA, and other process chemicals to product-related impurities like aggregates, misfolded proteins, and degradation products. The presence of impurities in antibody drugs can result in reduced drug efficacy, unexpected side effects, and patient safety risks. Moreover, regulatory authorities, including the FDA and EMA, require extensive impurity assessment to secure approval for clinical trials and market distribution. Therefore, robust and comprehensive impurity analysis is not just legally necessary but also crucial for maintaining your product's integrity and ensuring patient safety.
Our Antibody Drug Impurity Analysis Services
Our comprehensive antibody impurity analyses cover two main categories: process-related impurity analysis and product-related impurity analysis.
We specialize in detecting and quantifying impurities like host cell proteins, DNA, endotoxins, media components, and leachables and extractables, which may potentially contaminate the final product.
This includes modifications to amino acids, variants in size, charge-related variants, or degradation products. We employ a range of strategies for detecting this range of potential impurities.
Content and Methods of Impurity Detection
Utilizing advanced analytical techniques such as Mass Spectrometry and High-Resolution LC/MS, we are capable of accurately identifying impurities that can potentially compromise the safety, stability, and effectiveness of your products.
- Quantitative impurity analysis
We conduct thorough quantification of impurities within a sample, providing detailed reports that can guide tuning of your manufacturing process. Our dependable data contributes to a robust and safe product.
This service examines the total impurity profile of the antibody drug, identifying impurities that might be unique to the specific product and those that are generally associated with antibody drugs.
We employ a range of sophisticated techniques to identify and quantify impurities in antibody drugs. These include:
Features of Our Services
- Our team consists of experts in protein chemistry, biochemistry, and molecular biology, delivering precise, scientifically sound results you can rely on.
- Our tests are performed in accordance with international guidelines, ensuring your product meets the regulatory standards of agencies such as FDA, EMA, and ICH.
- We understand the importance of time-efficiency in your research and development process, and we strive to provide reliable results in a timely manner.
At Creative Proteomics, we understand the importance of impurity analysis and provide professional services. With our comprehensive impurity analysis services, your biopharmaceutical development can proceed with confidence. We are committed to aiding your antibody drugs development in the most efficient, rigorous and ethical way possible. For more information or to request our services, please feel free to contact us.
