Leaching

Leaching is a physicochemical process rather than a specific biological target molecule, receptor, or enzyme. In the biotechnology and pharmaceutical industries, it refers to the unintended migration of chemical or biological substances from manufacturing equipment, container-closure systems, or medical devices into a drug product under normal storage and use conditions [3, 4, 6]. Common examples include the leaching of Protein A from affinity chromatography resins during purification or the release of plasticizers (e.g., phthalates), antioxidants, and metal ions from plastic packaging into liquid formulations [1, 2, 5]. While leaching is not a therapeutic target, it is a significant concern for drug safety and efficacy, as 'leachables' can be toxic, carcinogenic, or immunogenic, and may also cause degradation of the active pharmaceutical ingredient [9, 10]. Consequently, characterizing and controlling extractables and leachables (E&L) is a critical regulatory requirement in drug development and manufacturing [6, 10]. Proper management of leaching ensures that any substances entering the drug product remain below established safety thresholds to prevent adverse patient reactions [10].

Other names

Extractables and leachablesE&LProtein A leachingMetal leachingMigration