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Plasmid products are sensitive to environmental factors. Therefore, stability testing studies can be performed on plasmid products under a variety of environmental conditions over a specific time frame. These tests play a critical role in assessing the transport, storage and shelf life of plasmid DNA. As your experienced partner, Creative Biogene performs comprehensive stability testing studies prior to GMP plasmid production and product release, providing useful insights into plasmid stability information. This service can also be used for stability testing of other biological products such as proteins, peptides, vectors, etc. We can provide professional services to any client who needs them.
Typically, plasmid samples are stored under controlled environmental conditions, including humidity, temperature, light and pH, and then analyzed at various time points. Data accumulated over time are used to determine the effect of different environmental conditions on product quality. There is no single stability metric or parameter that can describe the stability of a plasmid product. Creative Biogene performs a comprehensive portfolio of stability tests as required by ICH guidelines. Forced degradation experiments are performed to predict the effects of light, temperature and pH on plasmid DNA stability and purity, and potency.
As an example of a stability study of plasmid samples, Creative Biogene stores the samples under set conditions and performs the following tests as required by the ICH guidelines:
Our scientists are also good at stability testing of other biological products. For example, forced degradation tests, accelerated stability studies, short and long-term stability studies of proteins, antibodies and other biologics. We can develop a customized portfolio of stability study methods based on the client's demands or sample type to ensure that any changes or information on the physicochemical properties, structure, aggregation, bioactivity, visual appearance, impurities, etc. of the sample are detected for the client.
The test is designed to study the kinetic degradation of plasmid products to assess their shelf life. In real-time stability testing, the product is stored under recommended storage conditions and monitored until it does not meet product specifications. In accelerated stability testing, the product is stored under high stress conditions (e.g., high temperature and/or humidity). A known relationship between acceleration factor and degradation rate can then be used to predict degradation under the recommended storage conditions.
The test is performed in conjunction with a real-time stability test. During the test, the product is stored under elevated stress conditions (e.g., high temperature and/or humidity). Degradation at the recommended storage conditions can then be predicted using known relationships between the acceleration factor and the degradation rate.
This test is designed to investigate the stability of the product by using extreme storage conditions to increase the rate of degradation. The test results can provide information on product breakdown and degradation pathways.
Long-term stability studies at expected storage conditions and shorter duration studies at higher temperatures to support in-use stability and shipping conditions.
Creative Biogene's expert quality control services team is ready to discuss the design of your stability studies and interpretation of guidelines. We provide total quality assurance expertise to help you meet and exceed quality, safety and regulatory standards. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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