The reactivity of leachables is an area of growing concern, especially for therapeutic proteins and peptides, not only because it can lead to undesirable immunogenic effects, but it can also compromise the quality and efficacy of the drug product. In a lot of cases, an evaluation of the chemical structure of the leachable can “predict” its potential reactivity.

This presentation will explain the experimental work that Nelson Labs performed to link the structural reactivity to experimentally observed reactivity, using Glargine (an Insulin peptide) as a marker compound.

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