General Quality Property Analysis
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As with any pharmaceutical product, it is crucial to thoroughly characterize the quality attributes of antibody drugs to ensure their safety, efficacy, and consistent performance. Quality attribute characterization services play a vital role in this process by evaluating various parameters such as physical properties, purity, impurities, biosafety, and stability. At Creative Proteomics, we take pride in offering comprehensive quality attribute analysis and characterization services for antibody drugs. Our expert team of scientists utilizes cutting-edge techniques and advanced technologies to provide an in-depth understanding of the physical and chemical properties of antibody drugs.
Antibody Drugs General Quality Property Characterization Services at Creative Proteomics
Our services encompass various aspects of quality assessment to ensure the safety, efficacy, and consistency of antibody drugs. Here is an overview of the services we offer:
We employ a range of analytical techniques to evaluate the physical attributes of antibody drugs. This includes assessing solubility, aggregation propensity, viscosity, particle size, and formulation compatibility. By thoroughly examining these properties, we can identify any potential issues that may affect drug performance and efficacy.
Our team conducts comprehensive purity analysis to determine the percentage of antibodies present in the drug product. We utilize advanced analytical techniques and cutting-edge equipment to assess the purity of your antibody drugs, ensuring that they meet the required specifications and regulatory guidelines. Our comprehensive testing services include characterizing the composition, identifying impurities, assessing stability, and evaluating the overall quality of your antibody drugs.
We understand the importance of identifying and quantifying impurities in antibody drugs. Our experts can help clients determine the types and levels of impurities associated with antibody drug processes and products, helping to meet regulatory requirements and ensure product safety. We use advanced analytical methods such as high-performance liquid chromatography (HPLC), capillary electrophoresis (CE), and mass spectrometry to identify and quantify impurities, such as degradation products, host cell proteins, and DNA.
Assessing the safety profile of antibody drugs is crucial for both preclinical and clinical development. We provide comprehensive biosafety analysis services, including testing for endotoxins, mycoplasma, adventitious agents, and viral safety. Our state-of-the-art facilities are equipped to meet industry standards and regulatory guidelines.
Antibody drugs must demonstrate stability throughout their shelf life to ensure consistency and maintain potency. With our state-of-the-art laboratories and cutting-edge equipment, we offer comprehensive stability characterization services that encompass a range of parameters to assess the stability of antibody drugs. Our comprehensive stability characterization services include physical stability testing, chemical stability testing, storage stability testing and forced degradation studies.
Creative Proteomics, as a leader in antibody drug characterization services, is committed to selecting the appropriate compendial test procedures for antibody molecules and providing advanced technical support to help our clients accelerate their drug development and market submission process. For more information or to request our services, please feel free to contact us.
