Cell Substrate Characterization In Vitro-based Virus Detection Methods

Regulatory authorities such as the US Food & Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) impose stringent limits on the amount of microbial contaminates and impurities present during the manufacturing of biological medicines and vaccines.

To establish that the testing procedures are accurate, regulatory authorities require proof of testing before clinical trials can be approved or a batch of commercial biopharmaceuticals or vaccines be released. This white paper explores how all components of the manufacturing process must undergo extensive safety testing to demonstrate identity, stability and purity.