Robust sterility testing is essential to ensure the safety of cell therapies. However, traditional culture-based analysis takes several weeks to confirm a therapeutic’s microbial contamination, which ...

Key Benefits of the Microsart® ATMP Sterile Release Kit: Rapid Results: Obtain conclusive evidence of sterility in only 3 hours ... Streamlined Protocol: Our kit simplifies the testing process, ...

In the request, Mayes said the state would rely on stability testing conducted in 2022, and sterility testing would occur after the pentobarbital to be used on Gunches was compounded. Once that ...

However, it wasn’t until 2008 that the US Food and Drug Administration (FDA) codified container closure and integrity testing (CCIT) as a requirement to preserve product sterility. But ...

Sterility and mycoplasma testing in biotherapies, particularly cell therapy products, is critical. Developing an analytical strategy to detect contaminants such as mycoplasma can present several ...

Emergen Research Logo The extensive use of these products is largely responsible for the market's growth VANCOUVER, BC, CANADA, Febr ...