More than 20 years of experience
Structured approach
Stability indicating analytical methods
Selecting the best lead candidate is essential to de-risk drug development.
It involves intentionally subjecting a drug substance or drug product to harsh conditions, such as temperature extremes, humidity, exposure to light, and chemical agents, to accelerate the degradation of the product. The purpose of forced degradation studies is to:
Stability assessment under extreme conditions to predict its shelf life and storage requirements.
Identification of degradation products that may form during the drug's shelf life. Understanding the nature of these degradation products is crucial for safety and efficacy assessments.
Stress testing to assess the drug's vulnerability to various stress factors, including heat, humidity, oxidation, and light, to determine the critical degradation pathways. This information guides the formulation and packaging of the drug to protect it from these stressors.
Regulatory compliance requires forced degradation studies as part of the drug development process. The results are submitted in regulatory filings to demonstrate the drug's stability and safety.
Leukocare’s Forced Degradation Expertise
As forced degradation studies are crucial during the drug development process, Leukocare offers a full portfolio of testing methods. Whether you need stability data or are experiencing problems in downstream processing, we can help elucidate degradation pathways. Based on ICH Q1A guidelines, we use a well-established structured matrix of stress conditions to identify instabilities and aggregation problems. These include temperature, shear, freeze-thaw and light stress. In addition to our structured, laboratory-based approach, we apply state-of-the-art data science to interpret results for more comprehensive conclusions.
Key components of forced degradation studies, including:
Stress studies with chosen conditions based on the drug’s chemical properties and potential degradation pathways. Leukocare applies different types of stress to the DS according to ICH Q1A guidelines.
Time points when the samples are collected during the development to monitor changes in the drug’s stability and potential degradation products.
Analytical techniques such as HPLC or spectroscopy to detect and identify degradation products and assess the drug’s stability.
Characterization of degradation products by looking at the chemical structures of the degradation products to determine and understand their potential impact on safety and efficacy.
Validation of studies according to well-defined protocols and procedures to ensure the reliability and reproducibility of the results.
Stress studies within the ICH Q1A guideline:
Temperature
ICH compliant incubators at 5, 25, 40 °C
Shear force
Overhead rotation
Orbital shaking
Freeze-thaw
Various combinations of temperatures between -80 and +40 °C
Light
According to ICH conditions
Customized exposure protocols
