Biosafety for Large-Scale Containment Level 1 Operations Using Recombinant DNA Technology: No Emerging Hazards

Fink, Richard; Moran, Enda

doi:10.1177/153567600501000104

Cited by 3 publications

(3 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Furthermore, the potential transfer of genes from transgenic plants to microorganisms is strongly restricted by biological and physical barriers (Bertolla and Simonet 1999). These barriers include: degradation by acid and nucleases in the stomach and intestines (Jonas et al 2001); restriction and modification systems in bacteria that destroy foreign DNA that enters the cell (Frank 1994); absence of homologous ends for efficient integration into the bacterial genome (Fink and Moran, 2005) and lack of selective pressure. In addition, when any DNA (including antibiotic resistance genes) is integrated into the plant genome, the codon usage may have been altered for more-efficient expression in the plant and the gene may have picked up methylation patterns of the plant.…”

Section: Barriers To the Transfer And Expression Of Transgenes In Othmentioning

confidence: 99%

Biosafety and risk assessment framework for selectable marker genes in transgenic crop plants: a case of the science not supporting the politics

et al. 2007

View full text Add to dashboard Cite

Selectable marker gene systems are vital for the development of transgenic crops. Since the creation of the first transgenic plants in the early 1980s and their subsequent commercialization worldwide over almost an entire decade, antibiotic and herbicide resistance selectable marker gene systems have been an integral feature of plant genetic modification. Without them, creating transgenic crops is not feasible on purely economic and practical terms. These systems allow the relatively straightforward identification and selection of plants that have stably incorporated not only the marker genes but also genes of interest, for example herbicide tolerance and pest resistance. Bacterial antibiotic resistance genes are also crucial in molecular biology manipulations in the laboratory. An unprecedented debate has accompanied the development and commercialization of transgenic crops. Divergent policies and their implementation in the European Union on one hand and the rest of the world on the other (industrialized and developing countries alike), have resulted in disputes with serious consequences on agricultural policy, world trade and food security. A lot of research effort has been directed towards the development of markerfree transformation or systems to remove selectable markers. Such research has been in a large part motivated by perceived problems with antibiotic resistance selectable markers; however, it is not justified from a safety point of view. The aim of this review is to discuss in some detail the currently available scientific evidence that overwhelmingly argues for the safety of these marker gene systems. Our conclusion, supported by numerous studies, most of which are commissioned by some of the very parties that have taken a position against the use of antibiotic selectable marker gene systems, is that there is no scientific basis to argue against the use and presence of selectable marker genes as a class in transgenic plants.

show abstract

Section: Barriers To the Transfer And Expression Of Transgenes In Othmentioning

confidence: 99%

Biosafety and risk assessment framework for selectable marker genes in transgenic crop plants: a case of the science not supporting the politics

et al. 2007

View full text Add to dashboard Cite

show abstract

“…7 Several articles have been published addressing large-scale containment for recombinant technology. 8,9 These guidelines were originally drawn up to address monoclonal antibody and biologic production and do not include specific considerations when it comes to assessing additional risks pertaining to CGT.…”

Section: Current Industry Risk Assessment Methodologiesmentioning

confidence: 99%

Environmental Health and Biosafety Risk Assessment Guidance for Commercial-Scale Cell and Gene Therapy Manufacturing

DiGiandomenico

Dunn²,

Sadowski³

et al. 2020

Applied Biosafety

View full text Add to dashboard Cite

Introduction: This article aims to identify best practices, improve risk controls, and aid regulatory agencies in developing guidance for environmental and biosafety risk assessment for commercial-scale cell and gene therapy manufacturing. Methods: A cross-functional team should start with hazard classification and testing requirements for materials used or generated by the process and process hazard characterization. Results: The team develops a safety profile of the process to mitigate risks, including: product biological contamination risk and process controls, including raw materials, facilities, operator and environmental controls, and method of detection; a technical review of the process to evaluate the operational and engineering controls; monitoring systems to mitigate the risk of failure and/or breach of the system, preventing the release of material to the facility or operator exposure; site sanitization strategy and facility containment measures, including engineering designs, air handling systems, spill containment measures, surface cleanability, waste flows, and decontamination practices; a review of site practices, including process, employee, material and waste flows, staff training, controlled access, operator gowning, and emergency response plans/measures. Discussion: The cross-functional team should regularly reconvene to provide solutions for enhanced process control, process life-cycle management, monitor assumptions, and track performance. The plan must be revised following any relevant failure event or process change. Conclusion: A risk assessment template is shared to bring to the reader’s attention the complexity of commercial-scale manufacturing, areas to assess, potential questions to ask, and other pertinent parties who may input to the risk assessment.

show abstract

“…This issue has driven a variety of studies regarding to survival of GEMs in the environment and the putative horizontal gene transfer of recombinant DNA from GEM to indigenous bacteria, (Pontiroli et al, 2007 andKeese, 2008). Another consideration is the fate of the DNA in the environment and the stability of the DNA relative to the time required for a competent cell (a cell capable of taking up DNA) to take in the genetic material (Fink and Moran, 2005).…”

Section: Introductionmentioning

confidence: 99%

Detection and Behavior Study of Some Genetically Engineered Microorganisms Released in Soil Using Plate Counting, Gene Transfer Assay and Specific PCR Methods

Hassan¹,

Alzohairy²

2012

Journal of Agricultural Chemistry and Biotechnology

View full text Add to dashboard Cite

The objective of this study was monitoring and behavior study of genetically engineered microorganisms (GEMs) that might be accidentally or deliberately released into the environments. Three methods (plate count, gene transfer and specific PCR) were used with four genetically engineered E. coli strains (A:pJan25, B: pJan25, pGWB533 and pGWB404) harboring antibiotics resistance genes with additional gfp and gus genes as a molecular markers. The GEMs were added to soil microcosms at 10 7 cells/g soil and incubated at room temperature for 35 days. After intervals time 0, 7, 14, 21, 28 and 35 days, bacterial cells were recovered and CFU/g were estimated. The number of viable cells were decreased from 10 7 to 10 3 after 28 days with A: pJan25 and pGWB533 and reached to zero at 35 days. Strain B: pJan25 was survived up to 35 days (10 3 CFU/g), while pGWB404 was disappeared after 21 days. Comparing with sterilized soil, it was found that the viable cells were alive up to 35 days (CFU/g was 10 4).The variation of CFU and presence of a viable cells in soil microcosm may due to the effect of indigenous microbial populations and the type of strain. Specific PCR was applied on the random selected colonies at 14, 21 and 28 days only, the target genes was gfp and gus. The results showed the presence of both genes in all tested colonies. This indicated that the tested GEMs could be maintained their constructed genes at long incubation time. Horizontal gene transfer was also assayed using conjugation under laboratory and soil microcosm conditions to confirm that GEMs genes were transferred to other organisms and to monitor the persistence of GEMs genes in soil. The gene transfer was started at 14 days in sterilized soil and 21 days in soil microcosm. The conjugation frequency under laboratory and sterilized soil conditions was higher than under soil microcosm condition. The results showed that the used GEMs were able to transferred three genes to recipient cells. This indicated that these genes were plasmid harboring and it were transferred to a recipient Keywords: Genetically engineered microorganisms (GEMs), horizontal gene transfer, PCR, gfp and gus genes.

show abstract

Biosafety for Large-Scale Containment Level 1 Operations Using Recombinant DNA Technology: No Emerging Hazards

Cited by 3 publications

References 22 publications

Biosafety and risk assessment framework for selectable marker genes in transgenic crop plants: a case of the science not supporting the politics

Biosafety and risk assessment framework for selectable marker genes in transgenic crop plants: a case of the science not supporting the politics

Environmental Health and Biosafety Risk Assessment Guidance for Commercial-Scale Cell and Gene Therapy Manufacturing

Detection and Behavior Study of Some Genetically Engineered Microorganisms Released in Soil Using Plate Counting, Gene Transfer Assay and Specific PCR Methods

Contact Info

Product

Resources

About