Important Information
About
Bovine Serum Albumin
January 9, 2004
To Our Customers:
This response is to address customer’s inquiries
regarding the recent identification of a cow in Washington State infected with
BSE. This cow was a dairy cow in excess of 6 years of age. While trace-back and
trace-forward investigations are not complete, all tissue from this animal has
been isolated.
There is no possibility that serum from this cow was
used at American Bioanalytical’s manufacturing facility. The following facts are
cited to demonstrate the remoteness of American Bioanalytical’s albumin products
being infected with BSE.
1.
American Bioanalytical uses serum from West Laboratories, Inc.
exclusively. This is the foremost supplier of blood products in the
world. This blood is collected in Joslin, Illinois, and is over 2100km from
Washington State.
2.
Procedures at West Laboratories, Inc. dated June 2000, proscribe
collecting blood from cows, Canadian or suspect cattle.
3.
Thermal fractionation has been shown to be effective in prion clearance.
(see Budnick, et. al., BioPharm,
Oct 1994).
4.
Blood serum is considered to be a Category IV tissue by the European Pharmacopeia.
This category has, as the Pharmacopeia states, “No Detectable Infectivity.”
If there are any further questions, please feel free to
contact us at any time.
Quality Control
American Bioanalytical Inc.
15 Erie Drive
Natick, MA 01760
click here to see the European Directorate for the Quality of
Medicines (EDQM)
certificate
(pdf)
Below is a complete list of Bovine Serum Albumin products offered by
American Bioanalytical
AB01088 - Bovine Serum Albumin, heat shock
AB00440 - Bovine Serum Albumin,
fraction V
AB00441 - Bovine Serum Albumin, fraction V, low salt
AB00448 - Bovine Serum Albumin, fraction V, protease free
AB01240 - Bovine Serum Albumin,
fraction V, protease free, lyophilized
AB01087 - Bovine Serum Albumin,
acetylated, nuclease free
AB00445 - Bovine Serum Albumin,
fraction V, fatty acid free
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