In-Use Stability of Oncology Antibody Therapeutics: Risks, Analytical Strategies, and Regulatory Perspectives.

Authors

Carlos Victor Montefusco-Pereira

Published in

PDA journal of pharmaceutical science and technology. Oct 23, 2026. Epub Oct 23, 2026.

Abstract

Oncology antibody therapeutics, including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and multispecific antibodies, are therapeutically important yet physicochemically complex drug products. Their clinical performance depends on preserving structural and functional integrity throughout preparation and administration. Transfer from the primary container into a syringe, pump reservoir, infusion bag, filter, tubing set, or closed-system transfer device creates an in-use phase with mechanical, thermal, photochemical, interfacial, and microbiological risks that differ from those addressed by shelf-life studies in the unopened commercial container.This review examines in-use stability for oncology antibody therapeutics. It distinguishes shelf life, expiration date, beyond-use date (BUD), and in-use stability; evaluates degradation mechanisms, formulation effects, and device-material compatibility; reviews orthogonal analytical strategies; and assesses study design across the complete preparation and administration pathway. Regulatory and compounding expectations are considered without assuming that physicochemical stability alone establishes a permissible BUD. Published examples are interpreted at the level of the specific product, concentration, diluent, container, storage sequence, analytical panel, and aseptic-control context studied.

PMID:
42919676
Bibliographic data and abstract were imported from PubMed on 24 Oct 2026.

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