FDA EIR - Lonza Houston, Inc - February 18, 2022

An FDA pre-license inspection of Lonza Houston, Inc. was conducted from February 14-18, 2022. This inspection supported two Biological License Applications (BLAs) for beti-cel and eli-cel from bluebird bio, Inc. The regulatory framework for this inspection was the Compliance Program Guidance Manual-45 Biological Drug Products, covering systems such as Quality, Facility and Equipment, Materials, Production, Packaging and Labeling, and Laboratory Control.

While many areas of the Lonza Houston facility demonstrated good practices, the inspection highlighted several key issues. A primary finding concerned the Batch Record Review and Release process, where critical data from a specific electronic system was not fully integrated into the final paper batch records. Lonza Houston committed to addressing this by developing and incorporating summary reports from this electronic system into their batch records. Additionally, a software bug was identified within an electronic system used for Chain of Identity/Chain of Custody, which had the potential to allow unauthorized modification of sensitive GMP data, posing a data integrity risk. The firm engaged in discussions with inspectors regarding this vulnerability. Finally, the inspection noted the absence of a defined process for relabeling non-conforming commercial drug products if they were to be released under an Investigational New Drug (IND) application. Lonza Houston was advised to establish such a mechanism to ensure comprehensive compliance for product disposition.