Chimeric antigen receptor T-Cell (CAR-T) therapy has been approved by FDA to treat B-cell leukemias and has seen great clinical success. CAR-T cell manufacturing involves isolating T-cells from a ...

Approved biological products are required to be accompanied by analytical tests to demonstrate safety, purity, and potency. Manufacturing and testing processes for approved products are validated and ...

How many times have you read scary stories in the press about addictive drugs of unprecedented purity? How often in movies has the villain been the one to cook up an incredibly pure drug? “Pure” in ...

The HPLC analysis of amphotericin B reported in the literature used either a weak acid or the chelating agent EDTA in the mobile phase. The weak acid improves the chromatographic peak shape by ...