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Time: 57 min
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In biopharmaceutical development, functional assays are key to showing that a drug target fits the desired functionality and quality profile before moving on to the next stage of development. Often, more than one assay is required since biopharmaceuticals may have more than one mechanism of action (MoA).
Reporter-gene assays are growing in popularity as they can be designed to reflect a drug’s MoA, which is required by regulatory authorities to ensure efficacy and safety. Another area where functional assessment has gained traction is in relation to the complement system where drugs can interact with complement components and cause adverse effects.