Operational and Performance Qualification

LCGC International sat down with Faith Johnson of ECOLAB to discuss her career and work with the Females in Mass Spectrometry (FeMS) group.

In the development of protein-based drugs, deep analysis of glycan types and locations and high-throughput trending analysis of glycan profiles are crucial to maintaining product quality.

Deriving antibodies from plasma products involves several steps, typically starting from the collection of plasma and ending with the purification of the desired antibodies. These are: plasma collection; plasma pooling; fractionation; antibody purification; concentration and formulation; quality control; and packaging and storage. This process results in a purified antibody product that can be used for therapeutic purposes, diagnostic tests, or research. Each step is critical to ensure the safety, efficacy, and quality of the final product. Applications of AI/GenAI in many of these steps can significantly help in the optimization of purification and yield of the desired antibodies. Some specific use-cases are: selecting and optimizing plasma units for optimized plasma pooling; GenAI solution for enterprise search on internal knowledge portal; analysing and optimizing production batch profitability, inventory, yields; monitoring production batch key performance indicators for outlier identification; monitoring production equipment to predict maintenance events; and reducing quality control laboratory testing turnaround time.

Researchers from Austria, Greece, and Italy conducted a study to analyze volatile organic compounds (VOCs) present in Irish and Scotch whiskys using solid-phase microextraction (SPME) Arrow with comprehensive two-dimensional gas chromatography coupled to mass spectrometry (GC×GC–MS) to examine the organoleptic characteristics that influence the taste of spirits.

A study has used gas chromatography coupled to a time-of-flight mass spectrometer to build an electron ionization mass spectra database of more than 250 chemicals classified as either volatile or semi-volatile compounds. An additional, confirmatory layer of liquid chromatography–mass spectrometry analysis was subsequently performed.