Charge heterogeneity is present in most biopharmaceutical protein products. During the manufacturing process, charge heterogeneity of the protein therapeutics can occur due to enzymatic cleavage and chemical post-translational modifications (PTM). For therapeutics like ADCs, not only the antibody contributes to the heterogeneity but also the linker and payload, which add even more complexity to the charge variant profiles. Characterizing the charge heterogeneity of ADCs is essential for critical quality attribute (CQA) assessment to ensure drug safety, efficacy, and potency.
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.
