June 2024

Navin Rauniyar and Xuemei Han of Tanvex Biopharma USA recently discussed how identifying product-related variants through characterization enables the recognition of impurities that compromise the quality and safety of drugs.

In biotherapeutics manufacturing, controlling size variants of therapeutic monoclonal antibodies (mAbs) is critical for ensuring product quality.

This article discusses the challenges and effective solutions for high performance liquid chromatography (HPLC)-based analytical characterization of virus-like particles (VLPs).

In this month’s column, I highlight some of the primary considerations we face in method development and point to resources that can help users overcome uncertainty and develop highly effective 2D-LC methods.

This article describes the contents and associated calculations of CoAs for small-molecule drugs. It explains how these documents help to ensure drug quality in the supply chain.

In this installment, we establish why peak integration still poses challenges, and at the same time, see some of the computational techniques in action that we learn to use ourselves in future installments.

The basic operating principles of ion mobility spectrometers (IMS), their resulting strengths and weaknesses, and why both perfectly align with the capabilities and requirements of gas chromatographs are discussed.

Click here to view the LCGC International Europe June 2024 PDF in an interactive format.