Validation in Biotechnology and Well-Characterized Biopharmaceutical Products

Here is some of the most popular content posted on LCGC International this week.

A Monday session at the Eastern Analytical Symposium, sponsored by the Chinese American Chromatography Association, explored key challenges and solutions for achieving more sensitive oligonucleotide analysis.

A series of lectures focusing on emerging analytical techniques used to analyse food contamination took place on Wednesday 6 November 2024 at RAFA 2024 in Prague, Czech Republic. The session included new approaches for analysing per- and polyfluoroalkyl substances (PFAS), polychlorinated alkanes (PCAS), Mineral Oil Hydrocarbons (MOH), and short- and medium-chain chlorinated paraffins (SCCPs and MCCPs).

The method of standard additions (MoSA) enables quantification of volatile impurities in condensed-phase samples, such as emulsions, for which matrix-matched calibration standards are required. The technique is, however, expensive because it requires multiple analyses of each sample.

This article will discuss an ion-pair reversed-phase liquid chromatography mass spectrometry (IP-RPLC–MS) workflow for the characterization of three messenger RNA (mRNA) key critical quality attributes: 5’ Cap, ORF, and poly(A) tail.

Pharmaceutical excipients, such as polyethylene glycol-based polymers, must be tested for the presence of ethylene oxide (EtO) and 1,4-dioxane as part of a safety assessment, according to USP Chapter <228>.