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Manufacture Business Practice, Drug Delivery, Ingredients, Quality & Compliance, Small Molecules, Trends & Forecasts

Characterization of IgG monomers & their aggregates

sponsored by Malvern Panalytical

Introduction

In biopharmaceutical formulations one of the key factors that manufacturers need to understand is the propensity of their samples to aggregate. Aggregates in biologic drugs are undesirable for two reasons. They reduce the amount of active ingredient in the sample, thereby reducing efficacy, and they can stimulate immunogenic responses in the body. This in turn can lead to more rapid clearance of the drug and again reduce efficacy, or in some cases can lead to severe immune responses. Full characterization of protein drug samples is therefore necessary both for those developing formulations and those characterizing final products. It is therefore extremely important to have a technique which can both measure the amount of different protein aggregate components and identify and characterize each of them. In this way a sample can be fully characterized and understood.

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