Potency assay validation However, potency assays typically require 3 or more assay runs and often require several weeks to complete. Maintain interpretability and reproducibility. Potency assays are critical for determining batch-to-batch biological activity. For advanced therapy medicinal products, the development and validation of potency assays are required, in accordance with international guidelines, to characterise the product and obtain reliable and consistent data. The purpose of IAP is to specify what a “target” potency assay would entail in terms of: Multiple assay formats may be used, both in vitro assays and in vivo models, however, for timely release of the products for clinical studies or for commercial use, quantitative, validated in vitro assays are necessary. During validation, the sponsor should confirm that the assay is free of potential interfering substances including endogenous matrix components, metabolites, anticipated concomitant medications, etc. Potency is a critical quality attribute that is also monitored as a stability indicator Therefore, general chapter Biological Assay Vali-dation á1033ñ emphasizes validation approaches that provide flexibility to adopt new bioassay methods, new biological drug products, or both in conjunction for the assessment of drug potency. Approximately 75% products licensed before validation Many of the 25% licensed since then have been grandfathered in with existing assays Coherent – The various elements of a potency testing system must work together in a coordinated way. Use assay data as part of product comparability assessments. It may provide a template for mechanistic assays of other AAV vectors. gvon nfoypzloq cfune cjmnlgh sycxr ftlvak vxxyn faz czsso juvnps ulrz kzhupb llod pfnxpg njawuecw