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 ...

The Karnataka government has sought assistance from the Union Health Minister in countering the menace of sale of drugs whic ...

Besides, he requested the Union Health Minister to create a system for all States and Central laboratories to share alerts with each other regarding drugs which have failed quality testing, especially ...

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 ...