User:VolkerMorath/Safety
From 2010.igem.org
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Legal regularisation in the Federal Republic of Germany
In Germany all working that includes recombinant DNA technologies is regulated by the Gesetz zur Regelung der Gentechnik. This law regulates general aspects arising from the life sciences and refers for more precise interpretations in §4 to the Zentrale Kommission für die Biologische Sicherheit. The ZKBS is a commission composed of 20 technical experts that releases yearly statements to actual issues of biosafety. So far the ZKBS released three stratements affecting the work with Adeno-associated viral systems.
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At the Albert-Ludwigs-University Freiburg for all concerns of security the Stabsstelle Sicherheit is responsible and to contact if questions arise. Especially for questions of biological security Dr. Petra Markmeyer-Pieles is cognizant. We contacted her a first time befor the begin of our project in March when it was clear that the Adeno-associated Virus (AAV-2) was chosen as the topic of our project. At that time she proposed to do the cloning in the AAV-2 that is for sure to handle under biological security level 1 and to prepare everything for work under biological security level 2 to satisfy the precaution principle. The precaution principle was realized and all viral vectors that contained a modified capsid were handled under SII conditions until proven harmless. In August the planing of the project was completed, summarized in an Biosafety application and handed to the department for biological security of the regional board in Tübingen which had to to approve the whole project.
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Several composite parts that were assembled by our Team this year are alone capable of producing infectious viral particles when transduced together with a vector plasmid and a helper plasmid into AAV-293 cells. These special cells provide the adenoviral gene E1 stabily integrated in trans.
These cells are not provided in the Virus Construction Kit nor availible in the Parts Registry and have to purchased from other laboratories or a commercial supplyer.
For this reason we estimate the risk of a accidental transformation of AAV-293 cells with all three plasmids for negligible.
Nevertheless we considered it useful to mark every BioBrick or Composite Part in the Registry that contributes to the production or is capable of producing viral vectors when transformed under the previously mentioned conditions.