Buy this domain.
Genzyme Suspends Production at Drug Plant Following Discovery of Viral Contamination | cialis online

Genzyme Suspends Production at Drug Plant Following Discovery of Viral Contamination

AddThis Social Bookmark Button

Genzyme has suspended production at the Massachusetts plant where it makes Cerezyme and Fabrazyme because of viral contamination. The Allston Landing plant is the only one where Genzyme produces Cerezyme and Fabrazyme.   Cerezyme is used to treat Gaucher disease, while Fabrazyme is a therapy for Fabry disease.

According to Genzyme, the shutdown could impact supplies the two drugs.  The company’s press release said that current inventories are not sufficient to meet projected global demand. The timing and extent of the Cerezyme supply constraint is being clarified and will be communicated as soon as possible. The company expects Fabrazyme supply constraints to occur for a limited period beginning in September.  Genzyme said it  will work with physicians, patients and regulators to minimize the impact of this constraint.

According to a Genzyme press release, the virus Vesivirus 2117 has been detected in one of six bioreactors at its Allston Landing manufacturing facility.   This virus has not been shown to cause human infection, but it is known to interfere with the growth of CHO cells used to produce biologic drugs.  Genzyme said it  was likely introduced through a nutrient used in the manufacturing process.

Genzyme said it has now confirmed that this virus was the cause of declines in cell productivity at its Allston and Geel facilities in two previous instances in 2008, which were subsequently fully addressed. The company was able to detect the virus in this case using a highly specific assay it developed after standard tests were unable to identify the cause of the previous productivity declines. Genzyme said it is adding steps to increase the robustness of its raw materials screening and viral removal processes.

According to, the Allston Landing facility was the subject of a Food & Drug Administration (FDA) warning letter that followed an inspection in September and October.  One of the FDA’s concerns was controls to protect against microbial contamination, Reuters said.

« »

Leave a Reply

You must be logged in to post a comment.




Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!

Whistle Blower

Stand up and say what you think is right. See something, say something.