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The technical aspects of bioassay strategies are essential as ever while the biotech industry launches new biologics including modified proteins, DNA, RNA and cell-based therapeutics. The focus of this session will reinforce the importance of those bioassay technical features that contribute to the successful performance of a bioassay from assay development through to the post-marketing stage. Some of the common threads intersecting bioassay applications and strategies that will be discussed during this session include bioassay design considerations, critical reagents (e.g. reference standards), data analysis approaches, and control measures used throughout the product lifecycle.