Reference standards for autologous products: material is not immaterial

“...the [cell and gene therapy] field is rapidly advancing, and guidance documents are often trying to keep pace with innovation.”

Reference standards are highly characterized materials that are used to ensure the quality and consistency of drug products. They play a critical role in calibrating assays, validating analytical methods, qualifying critical reagents, and ensuring batch-to-batch comparability. Despite their importance, there is no specific regulatory guidance for the development of reference standards within the cell and gene therapy sector. This inevitably leads to a lack of consistency in identifying and qualifying suitable reference standards which can delay or hinder clinical development. This article highlights some of the challenges that cell and gene therapy developers face when selecting and characterizing suitable reference standards.

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