Cell Substrate Characterization In-Vitro Based 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 contaminants and impurities present during the manufacturing of biological medicines and vaccines. These regulations ensure sterile products and thus patient safety. 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. Consequently, all components of the manufacturing process must undergo extensive safety testing to demonstrate identity, stability, and purity.