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Freeze and Thaw Stability Assay

Creative Biolabs is a provider of laboratory testing and manufacturing services to the international life sciences market. Our services range from physical and chemical quality control assaying of pharmaceutical raw materials to finished dosage forms to cover release, stability, and validation. We can develop assay methods from scratch or based on client methods.

Freeze and Thaw Stability Assay

Stability studies are performed to assess the resistance of the drug candidate for storage and processing, such as freezing and thawing or cryopreservation. The freeze and thaw stability assay is a part of the stability testing and is a way to determine whether or not your formulation will remain stable under various conditions. It is common to freeze the formula, then thaw it and test how it affects your product. To perform a thorough freeze-thaw test, you must repeat the cycle several times. This process typically involves subjecting the sample to several cycles of freezing and thawing or lyophilization and redissolution and analysis of the aggregate content and biological activity of the sample.

Why Need Freeze-thaw Stability Assay?

Freeze-thaw stability assay is used to measure the effect of temperature changes on the formulation. There are two reasons for this, one is to measure overall stability as this accelerates the change, and the second is to mimic potential outdoor storage conditions of the final formulation. Therefore, the freeze-thaw assay gives you important information that is not available with routine stability testing. That is, it will show whether your formula will remain stable under varied conditions that may be encountered during the transportation and storage phases of the product life cycle.

Services

Freeze-thaw stability assays are necessary and should be performed to confirm the molecular specific stability of each molecule during process development. Storage involves two steps: one is freezing, where the molecules are subjected to subzero temperatures to turn into a solid-state, and the second is thawing, where the molecules return to room temperature at the end of storage. Creative Biolabs has extensive experience in physical stability assay and is able to customize test methods to meet customer's needs while maintaining adherence to the standards of these methods. The following is the protocol of our freeze-thaw stability assay:

Our expertise in innovative technology enables us to provide our customers with high quality and unique stability assay services. We work with our customers to provide individual advice and tailored solutions to help them achieve their goals. Please contact us to discuss whether or not the customized assay may be beneficial to your research.


All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.

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