the overall objective of this Core is to provide the necessary infrastructure for the expression and purification of biologic molecules including proteins, glycoproteins, peptides, and other biologies from the Risk Group 4 viral entrants for investigators associated with the NEIDL. The design of the NEIDL incorporates both BSL-3 and BSL-4 Biomolecule Production Core laboratories. We believe that this design maximizes the efficiency of research that will be performed under high containment in the Institute by minimizing the extensive downtime that would be required for conversion of a single flexible laboratory module. Moreover, this design allows for concomitant use of both high containment laboratories, thereby increasing by more than 2-fold the total work flow in this Core. For example, at the same time Kyasanur Forest Disease virus can be propagated for challenge studies in the BSL-4 Biomolecule Production Core laboratory, Francisella tularensis may be grown for the extraction and purification of capsule to be used in an experimental conjugate vaccine in the BSL-3 Biomolecule Production Core laboratory. With a single flexible laboratory housing this Core, this work would, by design, have to be conducted sequentially. This would result in considerable down time for decontamination, and re-certification following conversion from BSL-4 to BSL-3, and back again to meet the standards for each level of containment. From an operational perspective, not all personnel trained for work in the BSL-3 Biomolecule Production Core will necessarily have to be certified to work under BSL-4 containment. However, it is anticipated that workers trained and certified for BSL-4 work will also be certified for BSL-3. It is clear that the Standard Operating Procedures (SOPs) governing the growth and purification of proteins and carbohydrates from BSL-3 bacterial pathogens (e.g., Francisella tularensis, Yersinia pestis, multi-resistant Mycobacterium tuberculosis); versus BSL-4, the growth and extraction of proteins and glycoproteins from the BSL-4 viral pathogens (e.g., Kyasanur Forest Disease, Ebola, Marburg, Lassa), as well as decontamination procedures, and operational plans will be different and appropriate for each level of containment.
|LeDuc, James W; Anderson, Kevin; Bloom, Marshall E et al. (2009) Potential impact of a 2-person security rule on BioSafety Level 4 laboratory workers. Emerg Infect Dis 15:e1|