As part of the Quality Assurance
process, DNA plasmid stability is tested according to ICH guidelines for Drug Substance & Drug Product. These studies help to determine the effect of external factors on the active component within a customer’s product and are critical for regulators.
The effects of different levels of light, heat, humidity and oxygen levels, as well as a broad range of pH levels, are examined.
Forced degradation studies, to accelerate the natural degradation process, are also undertaken to determine the effect on the product.