Biologics

Aseptic Processing/Documentation Failures at Lonza Cell Therapy Facility

FDA has cited Lonza Portsmouth for significant manufacturing and quality control deficiencies at its New Hampshire cell therapy facility, raising concerns about aseptic processing, environmental controls, documentation practices, and deviation management related to the production of Vertex Pharmaceuticals and CRISPR Therapeutics’ gene-edited therapy Casgevy.

FDA investigators conducted the inspection 6/2025 at Lonza’s Portsmouth site and cited the form over deficient aseptic processing practices observed during review of closed-circuit television footage from a 5/2025 manufacturing run. Inspectors reported that operators routinely changed sterile gloves and adjusted equipment within Grade A and Grade B environments without following required gowning and contamination-control procedures, according to a just-posted FDA Form 483.

In multiple instances, operators were observed reaching into biological safety cabinets without taking prescribed precautions, leaning against equipment during active aseptic operations, and reentering manufacturing activities without appropriate disinfection, FDA says.

FDA also cited failures in cleaning and sanitization of Grade-classified rooms and biological safety cabinets used in Casgevy manufacturing. Inspectors observed cleaning staff retrieving items from floors with bare hands, omitting hard-to-reach areas from cleaning, and failing to apply disinfectants as required by internal procedures, the inspection report says.

Additionally, the inspection also uncovered practices inconsistent with good documentation standards. FDA reported finding original quality control records and review notes discarded in trash receptacles near laboratory areas. In one case, batch record signatures were altered months after execution, with original electronic records missing and no audit trail available.

Inspectors also cited the use of uncontrolled spreadsheets for tracking quality data, including returned materials and environmental monitoring results, without validation, access controls, or accountability safeguards — raising concerns about data integrity.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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