Latest Developments and Best Study Design Practices in Extractables & Leachables for Lyophilized Drug Products
Innovation Pitch
2026-05-28 | 10:40 AM - 10:55 AM | The Innovation Corner
Abstract
Although lyophilized presentations were historically considered lowrisk due to their solid state, current understanding shows that lyo systems possess unique container closure interaction pathways.
Outgassing from elastomeric components, together with the highly adsorptive character of the porous lyo cake, can lead to meaningful accumulation of volatile and semivolatile compounds. This increased presence of leachables on the lyo cake in a solvent-free environment can also facilitate the chemical interaction with the drug product. Furthermore, the nature of the manufacturing process, as well as the inherent stability and reactivity challenges posed by drug products typically found in lyophilized form, make this field one of the most complex puzzles in Extractables & Leachables study design.
We address the challenges facing Extractables and Leachables studies of lyophilized drug products, and the newest developments regarding study design.
