Genzyme Cited for Thymoglobulin Manufacturing Operations

Genzyme used components and intermediates for the production of bulk Thymoglobulin lots that exceeded prespecified bioburden and pathogenic microorganism limits, according to an FDA warning letter.

Thymoglobulin (anti-thymocyte globulin [rabbit]) is a polyclonal antibody that suppresses certain types of immune cells responsible for acute organ rejection. Genzyme Polyclonals manufactures the product in Lyon, France.

The relationship between two animal deaths, which occurred during safety and potency testing, and two adverse event reports in humans, all associated with the same bulk lot, did not trigger a thorough investigation into all areas of the production process, the FDA said.

Although the finished product derived from the lots in question met all specifications, the FDA said if the firm does not correct the problem, then the risk of future product failures would increase substantially. “Of particular concern is that you continued to use components and intermediates that did not meet your internal in-process limits,” the FDA told Genzyme.

The warning letter can be accessed at www.fda.gov/foi/warning_letters/s6520c.pdf.