Opinion: Airtightness for Decontamination by Fumigation of High-Containment Laboratories.

Introduction: While the European legislation states that laboratories of high-containment must be sealable for fumigation, they do not prescribe a minimal value for airtightness. Starting from a previous study in which we measured the airtightness in 4 BSL-3 laboratories with blower-door tests, we discuss the connection between airtightness and a successful decontamination by fumigation.

Methods: Biological indicators (BIs) consisting of spores of on metal disks were laid out in laboratories of different levels of airtightness before performing a fumigation with aerosolized hydrogen peroxide using an automated device, according to the manufacturer's instructions.

Environmental risk assessment of clinical trials involving modified vaccinia virus Ankara (MVA)-based vectors.

The modified vaccinia virus Ankara (MVA) strain, which has been developed as a vaccine against smallpox, is since the nineties widely tested in clinical trials as recombinant vector for vaccination or gene therapy applications. Although MVA is renowned for its safety, several biosafety aspects need to be considered when performing the risk assessment of a recombinant MVA (rMVA). This paper presents the biosafety issues and the main lessons learned from the evaluation of the clinical trials with rMVA performed in Belgium.

Engineering nucleases for gene targeting: safety and regulatory considerations.

Nuclease-based gene targeting (NBGT) represents a significant breakthrough in targeted genome editing since it is applicable from single-celled protozoa to human, including several species of economic importance. Along with the fast progress in NBGT and the increasing availability of customized nucleases, more data are available about off-target effects associated with the use of this approach. We discuss how NBGT may offer a new perspective for genetic modification, we address some aspects crucial for a safety improvement of the corresponding techniques and we also briefly relate the use of NBGT applications and products to the regulatory oversight.

Biosafety aspects of modified vaccinia virus Ankara (MVA)-based vectors used for gene therapy or vaccination.

The modified vaccinia virus Ankara (MVA) strain is a highly attenuated strain of vaccinia virus that has been demonstrated to be safe for humans. MVA is widely considered as the vaccinia virus strain of choice for clinical investigation because of its high safety profile. It also represents an excellent candidate for use as vector system in recombinant vaccine development for gene delivery or vaccination against infectious diseases or tumours, even in immunocompromised individuals.

Genetic modification through oligonucleotide-mediated mutagenesis. A GMO regulatory challenge?

In the European Union, the definition of a GMO is technology-based. This means that a novel organism will be regulated under the GMO regulatory framework only if it has been developed with the use of defined techniques. This approach is now challenged with the emergence of new techniques.

Bringing scientists to the people--the Co-Extra website.

Disseminating and facilitating access to science-based information is a necessity to enable the public to make informed decisions about appropriate uses of biotechnology products. It is also one of the major objectives of Co-Extra, a European-funded project addressing co-existence of genetically modified organisms and non-genetically modified organisms in Europe and their traceability. To this end, a dynamic and interactive website has been developed as the core element of the Co-Extra external communication strategy.