For the past 50 years, the Limulus amebocyte lysate (LAL) test has served as the foundation of drug and medical device manufacturing endotoxin control. Now, however, the United States Pharmacopeia (USP) has recognized the need to transition to recombinant methods.
Humans have been using biologics to treat disease for thousands of years. Unlike chemically derived medicines, biologics are typically very large, complex molecules or mixtures of molecules that are difficult to characterize.
As of 2023, CAR-T cell therapy is approved for use in individuals with some types of non-Hodgkin lymphomas, B-cell acute lymphoblastic leukemia, and multiple myeloma. While CAR-T cell therapy has shown remarkable clinical success in treating specific blood cancers, current manufacturing processes have significant room for improvement.
Matrix-assisted laser desorption ionisation (MALDI) uses a laser to absorb energy from a matrix to create ions with minimal fragmentation from large molecules. It can analyse biopolymers such as DNA, proteins, peptides, carbohydrates, and other organic macromolecules. In MALDI time-of-flight (TOF) mass spectrometry (MS), a TOF analyser measures the mass-to-charge (m/z) ratio of the charged molecules.
