Forced Degradation Study of Antibody Drugs

Forced degradation studies are an important part of antibody drug development. Forced degradation studies allow us to assess the drug's overall quality, establish degradation profiles, and identify potential degradation products or impurities. Creative Proteomics specializes in conducting forced degradation studies for antibody drugs. These studies help to understand the stability and degradation pathways of antibody drugs under different conditions and are important factors in establishing critical quality attributes (CQA) for protein therapeutics such as antibodies.

Purpose of The Forced Degradation Test

Forced degradation test refers to a series of tests in which APIs or preparations are subjected to relatively drastic test conditions to examine their stability. Generally speaking, the purpose of the test is mainly twofold:

• By examining the stability of a drug under a series of intense conditions, the inherent stabilizing properties of the drug, its degradation pathway and degradation products can be understood.
• These tests also provide a degree of validation of the specificity of the analytical methods used to examine the degradation products of the substance in question.

For newly developed antibody drugs, since all aspects of their properties are not well understood, the design of a more complete forced degradation test can provide a more comprehensive understanding of their stabilizing properties, thus providing a useful reference for the design of formulation prescriptions and processes, as well as the determination of product storage conditions.

Strategies for Forced Degradation Study of Antibody Drugs at Creative Proteomics

Our expert team utilizes various stress conditions, such as temperature, humidity, light, and pH, to mimic the potential degradation pathways encountered during storage, transportation, or administration processes. By subjecting antibody drugs to these stress conditions, we can evaluate their robustness and predict their shelf life. Our company offers a wide range of research strategies specifically designed for studying the forced degradation of antibody drugs. Here are several research services available for forced degradation studies on antibody drugs at our analytical laboratories:

• Forced degradation method development

We develop and validate specific methods for forced degradation of antibody drugs based on requirements and guidelines provided by regulatory agencies.

• Stress stability tests

We can perform stability testing on antibody drugs subjected to various stress conditions, including high temperatures, exposure to light, oxidation, and freeze-thaw cycles. These tests help identify potential degradation pathways and assess the drug's stability.

• Degradation product characterization

Our scientists can analyze and identify the degradation products formed during forced degradation studies using advanced analytical techniques, such as liquid chromatography-mass spectrometry (LC-MS) or high-resolution mass spectrometry (HRMS). This characterization provides insights into the degradation pathways and potential impurities that may arise over time.

• Analysis of Physicochemical Properties

We evaluate changes in various physicochemical properties of antibody drugs in forced degradation studies, including molecular weight, isoelectric point, charge heterogeneity, aggregation and fragmentation analyses. These analyses help assess the drug's integrity and potential stability concerns.

• Determination of degradation kinetics

We also perform more in-depth degradation kinetics studies to determine the degradation rate constants and half-life of antibody drugs under different stress conditions. This information is vital for understanding the drug's stability profile and shelf-life estimation.

Our Facilities and Technologies

At our research facilities, we maintain a world-class infrastructure that ensures accurate and reliable analysis of antibody drug degradation. Our laboratories are equipped with cutting-edge instrumentation, including high-performance liquid chromatography (HPLC), mass spectrometry (MS), nuclear magnetic resonance (NMR), and other spectroscopic techniques. This advanced technology allows us to detect and identify even trace amounts of degradation products and impurities, enabling a thorough characterization of the drug's stability profile.

What We Deliver?

Creative Proteomics' experts provide strong scientific and technical leadership, as well as program management and regulatory support Our customized research strategies can meet our clients' demands at any stage of development, moving your antibody drug development and manufacturing programs forward. For more information or to request our services, please feel free to contact us.