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To reduce timelines and provide the critical support needed throughout drug development, Abzena develops bespoke assays to meet the exact needs of our customers. As needs require, we develop more complex assays to satisfy regulatory requirements to proceed to clinical trials.
Relative potency assays are a critical part of a drug’s lifecycle. They are designed to ensure that the efficacy and potency of manufactured batches, drug substance and drug product is maintained throughout drug development and once the drug is in the market. This is particularly important for biologics with complex MoAs. For example, a successful antibody-drug conjugate (ADC) requires multiple steps including binding to its target, internalization, release of payload intracellularly, and elimination of tumour cells via the payload’s mode of action. An ideal relative potency assay captures all of these processes, and reports on the final biological outcome…
Contributors: Nathan Shaw, Grant Harradence, Robert Cunningham, Pearce Curran, Pooja Yadav, Luis Takiguchi, Adele Kinsey, Erika Kovacs, Rob Holgate, Campbell Bunce