Biotech Values

[DewDiligence]

Re: Purification and residual viral load in plasma-derived drugs

I recently checked the FDA product label for Evithrom (plasma-derived human thrombin from JNJ/Omrix) to see what level of purification is specified with respect to viral pathogens. The answer: about 5-10 logs (10); HIV is at the high end (10.2 logs), while BVDV (a close cousin of hepatitis C) is at the low end (4.7 logs).

Further, the Evithrom label contains the following language (emphasis added):

http://www.fda.gov/CBER/label/evithromLB.pdf

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17 PATIENT COUNSELING INFORMATION

Some viruses such as hepatitis A virus and parvovirus B19 are particularly difficult to remove or inactivate. Parvovirus B19 most seriously affects pregnant women or immune-compromised individuals. Symptoms of parvovirus B19 infection include: fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, fatigue and low-grade fever followed by nausea, vomiting and abdominal pain. Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear.
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FWIW