Tag: Stability of Antibody-Based Drugs

SOP for Conducting Stress Testing of Active Pharmaceutical Ingredients (APIs) Procedure for Stress Testing of Active Pharmaceutical Ingredients (APIs) 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stress testing of Active Pharmaceutical Ingredients (APIs) to determine their intrinsic stability and to identify degradation products. This information is used…

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How to Establish Shelf Life Using Stability Data Determining Shelf Life with Stability Data: A Step-by-Step Guide Introduction Establishing the shelf life of drug products is a vital step in the pharmaceutical development process, ensuring that the products remain effective and safe for use over time. Shelf life is determined based on stability data, which…

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How to Perform Real-Time Stability Testing for Drug Substances Step-by-Step Guide to Real-Time Stability Testing of Drug Substances Introduction Real-time stability testing is a fundamental aspect of pharmaceutical development, providing the most accurate representation of a drug substance’s stability under normal storage conditions. This type of testing is essential for determining the shelf life and…

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How to Design a Stability Study Protocol for Drug Products Creating an Effective Stability Study Protocol for Drug Products Introduction Designing a stability study protocol is a critical step in ensuring the safety, efficacy, and quality of drug products throughout their shelf life. A well-designed protocol outlines the conditions and procedures for stability testing, providing…

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How to Conduct Accelerated Stability Testing of Pharmaceuticals A Comprehensive Guide to Accelerated Stability Testing of Pharmaceuticals Introduction Accelerated stability testing is a crucial aspect of the pharmaceutical development process, allowing manufacturers to estimate the shelf life of drug products in a relatively short period. This type of testing is important because it helps ensure…

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How to Assess Stability for Drug Products in Extreme Conditions Stability Testing Guidelines for Pharmaceuticals Exposed to Extreme Environments Introduction Drug products that may be exposed to extreme conditions, such as high temperatures, freezing, high humidity, or low pressure (as in air transport), require specialized stability testing to ensure their safety and efficacy. Stability studies…

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How to Conduct Stability Studies for Temperature-Sensitive Biologics Stability Testing Guidelines for Biologics Requiring Strict Temperature Control Introduction Temperature-sensitive biologics, such as vaccines, monoclonal antibodies, and recombinant proteins, require precise stability testing to ensure they remain effective and safe throughout their shelf life. These biologics are often sensitive to temperature fluctuations, which can lead to…

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How to Perform Stability Studies for Sterile Products Stability Testing Guidelines for Sterile Pharmaceuticals Introduction Sterile products, including injectables, ophthalmic solutions, and surgical irrigations, require rigorous stability testing to ensure they remain free from microbial contamination, effective, and safe throughout their shelf life. These products must meet stringent sterility and quality standards to prevent infection…

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