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Baxter H5N1 Contamination: Causes were a unique combination of process, technical and human errors
Since we started our coverage of the Baxter-Contamination Story in Europe shares of the big pharmaceutical company in Deerfield, IL have lost more more than 8 percent in two days, as a look at Google Finance reveals. Baxter's Chief of Communications in the US, Christopher Bona, supported our idea for an exclusive interview, so Jutta Brenn-Vogt, Manager Communications at Baxter Deutschland GmbH explained LifeGen.de what really happened with H5N1, and how security measures - not only at Baxter - should work on a global scale.
LifeGen.de: How and when did Baxter find out about the contamination?
Brenn-Vogt: A suspicion concerning a potential contamination arose at AVIR Greenhills' contracted lab in the Czech Republic during the late afternoon of Friday, February 6. Baxter was then notified by AVIR Greenhills about this situation in three locations (Slovenia, Czech Republic, Austria) during the early evening of Friday, February 6. The last notification was on February 17 from AVIR Greenhills regarding a laboratory in Germany.
LifeGen.de: Promed mentions H5N1 and/or H3N2 as contaminants. Could you describe us what exactly happened to the charges?
Brenn-Vogt: Firstly, the material that was contaminated with H5N1 was not a vaccine, but was an experimental virus material. The impacted material was made at Baxter’s facility in Orth, Austria. It was produced exclusively for laboratory testing for AVIR Greenhills. It was not used for product production or for use in humans.
The root cause of the incident has been identified. It was due to a unique combination of process, technical and human error in a procedure used for this specific research project in our facility in Austria (Orth). The chances of such a confluence of events repeating itself are virtually impossible. Cross-contamination of commercial product, clinical material or other experimental material has been absolutely excluded. The public health authorities in Austria performed an audit at Baxter’s research facility in Austria and Baxter’s corrective and preventative actions were found appropriate by the auditors. The contamination occurred only during the process for this specific research project for AVIR Greenhills in Baxter’s facility.
The employees who may have been exposed to this material have gone through a specific examination by infectious disease specialists. These people were tested or considered by disease specialists not to be at risk. The results of all performed tests were negative.
LifeGen.de: Baxter is handling H5N1 in BSL3 labs. Where is the security lack of the system? In other words: How could the charges get in European 4 countries without intention?
Brenn-Vogt: As this material was not produced for human use, testing for potential contamination is not routinely carried out. Baxter sent this material to AVIR Greenhills in Austria, they, in turn, reported to us later that they sent it to four labs with whom they contract. As explained above, this was not the result of a lack of security but it was due to a unique combination of process, technical and human error in a procedure used for this specific research project.
LifeGen.de: Do you think smaller companies like Avir Green Hills Biotechnology should handle Baxter's charges?
Brenn-Vogt: Baxter is contracted to provide influenza virus material to AVIR Greenhills for that company's use in developing their influenza vaccine. In this case, Baxter produced one component of the influenza vaccine. The individuals working with the experimental material were operating in laboratory containment conditions specifically designed to prevent exposure. We see no need to speculate on how the size of a lab had bearing on this incident.
LifeGen.de: After the Antrhrax mailings in 2001, which is no Baxter related case, but not less risky, this is the second virological contamination starting directly
from the US. How will Baxter prevent future accidents like the one in Europe for the future?
Brenn-Vogt: Exposure was highly unlikely -- the individuals working with the experimental material were operating in laboratory containment conditions specifically designed to prevent exposure. All H5N1 infections that have been reported to date have been associated with direct exposure to infected poultry/birds.
As mentioned above, this incident originated in Austria, not the US. The circumstances of the contamination were a unique combination of process, technical and human errors. Cross-contamination of commercial product, clinical material or other experimental material has been absolutely excluded. The public health authorities in Austria performed an audit at Baxter’s research facility in Austria (Feb. 16) and Baxter’s corrective and preventative actions were found appropriate by the auditors. The contamination occurred only during the process for this specific research project for AVIR Greenhills in Baxter’s facility. Further details about the process will not be discussed as it is proprietary information.
LifeGen.de: Will the contamination in Europe lead to management changes in your company?
questions by Vlad Georgescu
The special interest online-magazine LifeGen.de reaches more than 90.000 unique users coming from 146 countries worldwide. The magazine is read by the scientific community, by members of political institutions and by major public media. LifeGen.de was founded in 2001 an is considered to be one of Europes most important lifescience Online-Magazines. More than 7100 articles can be found at the German Business Information (GENIOS)
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