Characterizing intact biotherapeutics such as monoclonal antibodies (mAbs) and antibody-drug
conjugates (ADCs) under physiological conditions is essential for understanding their critical quality
attributes. This paper will examine several advanced chromatographic and detection solutions—including
SEC, HIC, affinity chromatography, MALS, and HRMS—to support structural analysis, molecular weight
determination, and DAR quantification.
In this seventh part of " Conversations with Michael Dong," a series on fundamentals of HPLC in pharmaceutical analysis, LCGC International’s "Perspectives in HPLC" column editor explains why 2.1-mm i.d. columns are less preferred for pharmaceutical quality control.
Ultrahigh-performance liquid chromatography–quadrupole time-of-flight mass spectrometry (UHPLC–QTOF-MS) shows how soaking and cooking break down soybean fats.
Nicolai Zederkopff explores chromatography’s role to help implement the maximum tolerable level (MTL) framework for food adulteration to translate analytical results into compliance decisions.
Franz Berthiller (BOKU University, Austria) discusses a multilaboratory study that used retention index markers to align mycotoxin liquid chromatography–mass spectrometry (LC–MS) data.
A QuEChERS/ultrahigh-performance liquid chromatography and high-resolution mass spectrometry (UHPLC-HRMS) method tracks 23 plant toxins in cereals and spices. Michele Suman discusses the method with LCGC International.
