Formal and Informal Stability Testing for Live Biotherapeutic Products
During the process of drug development and approval, strict stability testing must be carried out to ensure the safety, integrity, shelf life, and storage conditions of the drug. The stability study should be well designed so the properties of the drug product can be estimated with a high degree of accuracy. At Creative Biolabs, we have the expertise to optimize each detail to ensure you get your desired outcome, achieving the highest levels of efficiency throughout.
Stability study is a key step in new drug and new formulation development. The stability of a drug refers to ability of a particular formulation in a particular container / closed system to maintain its physical, chemical, microbiological, toxicological, protective, and informative specifications.
Objectives of Stability Testing
Stability testing is designed to understand how the quality of APIs or drug products changes over time under various environments and to determine the retesting period or shelf life of APIs and recommended storage conditions.
Stability Testing Methods
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Real-time stability testing
Real-time stability testing is usually conducted over a longer period allowing significant degradation of a product under recommended storage conditions. The test cycle should be long enough to indicate that no measurable degradation occurs and must allow degradation to be distinguished from inter analytical variations.
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Accelerated stability testing
In accelerated stability testing, a product is stressed at several high temperatures, and the amount of heat required to cause product failure is determined. The purpose of this is to make the product in a state of accelerated degradation. This information is then used to predict shelf life or to compare the relative stability of alternative formulations.
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Retained sample stability testing
This is a usual practice for every marketed product for which stability data are required.
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Cyclic temperature stress testing
This is not a routine testing method for products already on the market. In this method, the cyclic temperature stress test is designed based on understanding the product to simulate the possible conditions of market storage.
Protocol for Stability Testing
Design a protocol for stability testing is a prerequisite. It is necessary to create a document that describes the critical components of the normative and well-controlled stability study. A well-designed stability protocol should contain the following information.
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Selection of batches
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Orientation of storage of containers
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Sampling plan
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Test parameters
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Acceptance criteria
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Container closure system
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Sampling time points
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Test storage conditions
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Test Methodology
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Photostability testing
Stability tests are carried out so that recommended storage conditions and shelf life can be included on the label to ensure that the medicine is safe and effective throughout its shelf life. Creative Biolabs will customize the most reasonable stability testing scheme for you according to your project requirements, and provide you with specific solutions to help you carry out the project more smoothly. If your project has progressed to this stage, please do not hesitate to contact us.
For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.
