USP In-Process Revision Chapter <1223>, Validation of Alternative Microbiological Methods

The USP Expert Committee in Microbiology recently published a draft in-process revision of chapter <1223>, Validation of Alternative Microbiological Methods in the USP Pharmacopeial Forum (PF). Highlights include more detailed discussion and methods for validation parameters such as methods for demonstrating Limit of Detection, and multiple options and statistical calculations for... read more

Can the BacTx Bacterial Contamination Assay be Useful for Cell Therapy Products?

Researchers evaluating a rapid assay for detection of bacterial contamination in platelets suggested that a point-of-release assay using the BacTx (Immunetics, Inc.) might give an additional level of safety for platelet transfusion recipients. The BacTx assay is a colorimetric, qualitative, QC test for the detection of aerobic and anaerobic, Gram-positive and... read more