Stability Analysis of Antibody Drugs
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Stability testing is a critical component in the development and commercialization of antibody drugs. It involves evaluating the chemical, physical, and biological characteristics of drugs over time to ensure that their quality, safety, and efficacy remain consistent throughout their shelf-life. At Creative Proteomics, we provide comprehensive stability testing services for antibody drugs, offering a range of studies to support the integrity and reliability of your product.
Importance of Stability Testing for Antibody Drugs
Stability testing plays a vital role in the development of antibody drugs as it provides essential information on the drug's shelf-life, storage requirements, and formulation stability.
Antibody instability can lead to reduced production yields, lost or impaired efficacy, harmful immune reactions, patient-associated complications and limited or lost function when working in extreme conditions or during long-term storage (which is crucial for many antibody-based test formats and sensors). Because stability affects the efficacy of increasingly important antibody-based diagnostics and therapeutics, the study, analysis and promotion/enhancement of antibody stability during expression, production, storage (shelf-life) and application, are pressing issues.
Stability Testing Services for Antibody Drugs at Creative Proteomics
At Creative Proteomics, we offer a range of stability testing services designed specifically for antibody drugs. Our services include, but are not limited to:
We conduct forced degradation studies to assess the susceptibility of antibody drugs to different stress conditions. By subjecting the drugs to high temperature, light, humidity, and oxidative stress, we can identify potential degradation pathways and degradation products, allowing for the development of robust antibody drugs.
Accelerated degradation studies involve exposing antibody drugs to elevated temperatures, humidity, light, and sometimes even chemical accelerants. We offer customizable accelerated degradation study designs to accommodate the specific needs of our clients. Our comprehensive reports provide detailed information on the degradation kinetics, identification of degradation products, and potential degradation pathways observed during the study.
We subject antibody drugs to controlled degradation conditions, including temperature, humidity, light, and pH variations, to simulate the potential degradation pathways over an extended period. This enables us to identify degradation products, evaluate degradation kinetics, and determine stability-indicating parameters.
Antibody Drug Stability Test Methods at Creative Proteomics
- Peptide fingerprinting by Chromatography and Mass Spectrometry (MS)
- Peptide mapping and sequencing by LC-MS/MS including S-S (Di-sulphide) bridge mapping analysis
- Higher order structure characterisation by Circular Dichroism (CD), Nuclear Magnetic Resonance (NMR), Infra -Red Spectroscopy (FTIR) and other methods
- Gel electrophoresis (1-D and 2-D SDS-PAGE reducing and non-reducing)
- Western blot
- Isoelectric focusing
- Capillary electrophoresis (CE)
- Carbohydrate and glycosylation studies
- Liquid chromatographic patterns
- Immunochemistry techniques
- Cell-based Bioassays
- Spectroscopic profiles
Why Choose Us?
- Comprehensive analysis
- High-quality data
- Customized approach
- Fast turnaround time
- Regulatory compliance
Creative Proteomics is proud to offer antibody drug stability analysis services that aim to optimize the development and production processes of antibody-based therapeutics. Our team of experts utilizes state-of-the-art technologies, extensive knowledge, and industry best practices to deliver accurate and reliable results. For more information or to request our services, please feel free to contact us.
