On the safety of Bacillus subtilis and B. amyloliquefaciens: a review
On the safety of Bacillus subtilis and B. amyloliquefaciens: a review
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DOI：
10.1007/bf00164689
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发表时间：
1991-10
影响因子：
5
通讯作者：
Anne de Boer Sietske;B. Diderichsen
中科院分区：
文献类型：
--
作者：
Anne de Boer Sietske;B. Diderichsen
多年来，发酵工业已经使用微生物来生产抗生素、氨基酸、酶和其他有用的化合物。这些微生物已经从环境中分离出来，然后进行突变以增加所需产品的产量，已经证明处理起来是安全的。随着基因技术的出现，现在有可能将遗传特性从一种生物体转移到另一种生物体。人们普遍认为，只要受体微生物（宿主）是无害的，并且要转移的基因产物是无害的，基因工程微生物（重组体）就与宿主一样安全，预计工业上使用的绝大多数重组微生物都是基于无害的宿主（OECD 1986）。其中许多已被证明是安全的，多年的经验，在工业环境中。此外，在文献中可以找到关于其中一些生物体不能引起疾病（即非致病性和非致毒性潜力）的广泛信息。我们认为，对这些宿主生物的文献和现有经验进行综述，将有助于评估许多重组生物的安全性。特别是，它可能有助于将其中一些分类为OECD（1986）定义的GILSP（良好工业大规模规范）宿主生物体，从而促进通过既定生产程序使用重组菌株。此外，对选定的宿主微生物进行安全性审查可能会简化由这些宿主衍生的重组菌株生产的产品的批准过程。因此，合格的专家认为，使用基因工程本身并不需要进行任何额外的安全评估。相反，使用安全和众所周知的宿主生物体有时可能会使一些新药物的广泛动物试验变得多余。
For many years the fermentation industry has used microorganisms to produce antibiotics, amino acids, enzymes and other useful compounds. These microorganisms, which have been isolated from the environment and then mutated to increase yields of the desired product, have proved safe to handle. With the advent of gene technology, it is now possible to transfer genetic properties from one organism to another. It is widely accepted that as long as the recipient microorganism (the host) is harmless and the products of the genes to be transferred are innocuous, the genetically engineered microorganism (the recombinant) is as safe as the host.An overwhelming majority of recombinant microorganisms to be used by industry are expected to be based on harmless hosts (OECD 1986). Many of these have been proven safe over many years of experience in industrial settings. Furthermore, extensive information on the incapacity to cause disease, ie non-pathogenic and non-toxicogenic potential, of some of these organisms can be found in the literature. We believe that a review of the literature and present experience with some of these host organisms will be useful for assessment of the safety of many recombinant organisms. In particular it may help to classify some of these as GILSP (Good Industrial Large Scale Practice) host organisms as defined by the OECD (1986), thus facilitating the use of recombinant strains by established production procedures. Furthermore, safety reviews on selected host microorganisms may ease the approval process of products produced by recombinant strains derived from these hosts. Thus it is the opinion of qualified experts that the use of genetic engineering per se does not warrant any additional safety assessment. On the contrary, use of a safe and wellknown host organism may sometimes render superfluous some of the extensive animal testing of a new