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Gammagard and reported hepatitis C virus episodes

¹Baxter Healthcare Corporation, Hyland Division, Glendale, California, USA.

Clinical Therapeutics

|January 1, 1996

Summary

Gammagard, a vital immunoglobulin therapy, was linked to hepatitis C virus transmission in 1994 due to manufacturing issues. Investigations identified at-risk donors and manufacturing steps, leading to improved safety protocols for this essential treatment.

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Area of Science:

Immunology
Virology
Pharmaceutical Manufacturing

Background:

Gammagard, an intravenous immunoglobulin (IVIG) product, was widely used and considered safe since 1986, even for patients with immunoglobulin A (IgA) deficiency.
Despite its established safety profile, reports emerged in early 1994 linking Gammagard batches manufactured from April 1993 onwards to hepatitis C virus (HCV) transmission.

Purpose of the Study:

To investigate the mechanisms of hepatitis C virus transmission associated with Gammagard administration.
To review the manufacturing processes and analytical studies conducted by Baxter and the US Food and Drug Administration (FDA) to understand the HCV transmission events.

Main Methods:

Utilized first- and second-generation enzyme-linked immunosorbent assays (ELISAs) and polymerase chain reaction (PCR) analyses to detect HCV.
Examined the effectiveness of the solvent-detergent viral inactivation step in the manufacturing process.
Conducted evaluations of donor histories to identify individuals who contributed to implicated Gammagard lots.

Main Results:

Identified specific Gammagard manufacturing lots associated with hepatitis C virus transmission.
Excluded a group of donors who contributed to the implicated lots from future donations.
Established classification schemes for patient reports of hepatitis and HCV episodes linked to Gammagard.

Conclusions:

The study highlights potential risks associated with plasma-derived products and the importance of rigorous manufacturing controls.
Investigative findings led to the exclusion of specific donors and underscored the need for continuous monitoring and improvement of viral inactivation methods.
The analysis provided a framework for classifying and understanding HCV transmission events related to Gammagard administration.

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