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Stand Alone Stability Testing

Cobra offers stability testing of customers’ DNA, protein, virus and cell products as a stand-alone service. Materials are tested according to ICH guidelines for Drug Substance & Drug Product, with the option of forced degradation and stability to support pre-formulation studies.

As part of the Quality Assurance process (material shelf-life assessment), products are tested according to ICH guidelines. The effects of different levels of light, heat, humidity and oxygen
levels, as well as a broad range of pH levels, are examined. These studies help to determine the effect of external factors on the active component within a customer’s product.

Forced degradation studies, to accelerate the natural degradation process, are also undertaken to determine the effect on the product.

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