Process-Related Impurity Analysis
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Antibody-based drugs play a pivotal role in the treatment of various diseases, including cancer, autoimmune disorders, and numerous infections. However, the production process of these drugs may lead to the formation of unwanted impurities that can affect drug efficacy and safety. Creative Proteomics, as a pioneer in antibody drug characterization services, we provide efficient and professional antibody drug process-related impurity analysis services. Our comprehensive service focuses on the detection, identification, and quantification of these process-related impurities to ensure the highest standards of product quality, safety, and efficacy.
What We Test?
An array of impurities can appear in antibody drugs during the production process, including enzymes, unreacted reagents, column binders, cell culture media components, and more. We test for all such process-related impurities including host cell proteins (HCPs), residual DNA, residual protein A, endotoxins, and enzymes like Proteinase K, Trypsin, and Chymotrypsin. We also monitor product-related impurities such as aggregates, fragments, glycosylation variants, and charge variants. These impurities, if left unchecked, can significantly impact the drug's performance, stability, and safety.
During the production process, the host organism's cells produce both the desired protein – the antibody drug – and other proteins unique to the host organism. Creative Proteomics employs high-throughput enzyme-linked immunosorbent assays (ELISA) for the efficient and accurate detection, identification and quantification of residual HCP in antibody drug products. Our assay services help ensure the safety, efficacy and consistency aspects of the final drug product.
The introduction of protein A residue testing service for antibody drug manufacturing processes is a significant step in ensuring the quality and safety of antibody drugs. Creative Proteomics provides clients with accurate protein A residue testing by ELISA to ensure the safety and efficacy of these drugs.
Exogenous DNA can arise from bacterial, yeast, or mammalian cultures used in the manufacturing process of antibody drugs. These DNA residues, if unchecked, can lead to potential adverse immunogenic reactions in patients. Through our state-of-the-art laboratories and competent teams, our Exogenous DNA Residue Testing Service is designed to ensure your antibody drugs are free from extraneous DNA contaminants. We use highly sensitive polymerase chain reaction (PCR) protocols to detect and quantify trace amounts of exogenous DNA.
Our Methods
We employ state-of-the-art analytical technologies to conduct a comprehensive analysis of antibody drug impurities. Our extensive analysis methods include ELISA for host cell protein and residual DNA detection. We also take advantage of advanced bioinformatics tools and biophysical techniques for high-throughput analysis, offering a fuller understanding of the impurity profile of the product. Different types of antibody drugs may have different process-related impurities, we will analyze the actual situation and select the appropriate assay for our customers.
Services Features
- Customized testing solutions.
- Advanced analytical techniques.
- Timely project delivery.
Creative Proteomics is committed to providing customers with efficient and rapid antibody drug impurity detection services, identifying and quantitatively analyzing process-related impurities in drug products to ensure product safety and efficacy. For more information or to request our services, please feel free to contact us.
