Question

The Genzyme plant in Massachusetts produces biotherapeutic enzyme replacement for people with Gaucher's disease. The plant was shut down by the FDA at one point causing a drug shortage concern for many patients. What was the reason for the shut down?

-FDA found evidence of poor documentation/record keeping
-Glass pieces were found in the drug product
-Vials of the therapeutic protein were found contaminated with a simian virus
-Cell cultures got contaminated with a virus
-FDA found unsanitary manufacturing conditions

Answer 1

The FDA shut down the Genzyme plant in Massachusetts due to contamination of the therapeutic protein with a simian virus, which created a drug shortage crisis for patients with Gaucher's disease, an enzyme-deficiency disorder.

Step-by-step explanation:

The Genzyme plant in Massachusetts, which produces biotherapeutic enzyme replacement for Gaucher's disease, was shut down by the FDA due to vials of the therapeutic protein being contaminated with a simian virus.

This interruption raised significant drug shortage concerns for Gaucher's disease patients, as the production of biotherapeutics is crucial for treating this enzyme-deficiency disorder.

Enzyme-deficiency disorders, such as Gaucher's disease, occur when the body cannot produce a specific enzyme, which leads to the buildup of toxic chemicals or the lack of essential products.

In Gaucher's disease, patients lack the enzyme glucocerebrosidase, which results in harmful substances accumulating in certain organs. The manufactured enzymes from facilities like Genzyme's provide vital treatment to patients by compensating for their enzyme deficiency.

The need for rigorous safety and quality measures in biomanufacturing is critical, as it ensures patient safety by preventing contamination of drugs, like in the Genzyme case. FDA oversight serves as a necessary step to protect patients from the potential dangers of contaminated Pharmaceuticals.