Schedule of EBSA Conference 2024 and Preconference courses

Submit your proposal for oral presentation here

Laboratory accidents and pathogen escapes are more commonplace than reported. Most laboratory-related incidents are caused by errors in following standard of procedures (SOPs) and emergency response measures, owed to insufficient training or fatigue of workers. To reduce the occurrence of operational errors it is imperative for biosafety training practices to follow a risk-and-evidence based approach. Establishing provisional risk analysis strategies will ensure biosafety encompasses individuals in the lab, as well as the wider community and environment.

As such, the WHO Risk Assessment Tool (WHO RAST) mobile phone application was developed to enable scenario-based risk assessment and evidence-based decision support. The application offers an accessible way to follow the biosafety risk assessment guidelines outlined in the WHO Laboratory Biosafety Manual 4^th edition (LBM4). The WHO RAST app utilises a logic-based algorithm to assess the risk associated with intended laboratory activities in diagnostic, research, or fieldwork settings. The introduction of technology and immersive tools will progress the current biosafety and biosecurity training landscape, by providing an interactive learning environment for laboratory personnel.

To ensure successful implementation of the WHO RAST in biosafety programs and training, the validity of the risk outcomes and control recommendations will be compared against the WHO SEARO Risk Assessment Manual as well as SOPs used in the Mahidol-Oxford Tropical Medicine Research Unit (MORU) laboratory network. The objective of this study is to 1) determine gaps in the WHO RAST app, 2) understand the local feasibility of implementing WHO RAST and other similar learning tools in laboratories, and 3) gather feedback to enhance usability of the app. It is essential for risk assessment processes and tools to be validated prior to implementation to safeguard individuals working in the lab, as well as the general public. Ultimately, an accurate risk prediction model can proactively aid in the prevention of biosafety incidents and improve response capacity of laboratories.

Much research is being done on the development and application of ‘viral replicons’. Viral replicons are derived from viruses (virus vectors) and are used, among other things, in research on vaccines and cancer. Replicons are able to replicate their viral genome, but cannot form new virus particles and are therefore unable to spread further. This is because one or more genes encoding the structural proteins that make up the virus particle have been deleted or replaced by a transgene. If structural proteins are provided externally during production, replicon RNA is packaged in so-called viral replicon particles. Examples of replicons are the self-amplifying mRNA vaccines against COVID-19 and influenza.

The Netherlands Commission on Genetic Modification (COGEM) is of the opinion that given the characteristics of replicons and viral replicon particles derived from alphaviruses (genus Alphavirus) and flaviviruses (genus Flavivirus), generic downscaling of containment requirements is possible. Depending on which structural genes have been deleted, COGEM advises the following:

• Laboratory work with ‘naked’ alphavirus or flavivirus replicons can be carried out at containment level I, or at one level lower than the pathogenicity class of the parental virus;
• Laboratory work with viral replicon particles can be carried out at one level lower than the pathogenicity class of the parental virus;
• Generic conditions apply to work with both naked replicons and replicon particles: the cells used must contain no related alphaviruses or flaviviruses, and the transgenes used must not restore the removed functions;
• In addition, viral replicon particle preparations must not contain any virus generated during production that is capable of replicating and spreading.

When the above conditions are met, COGEM considers that the environmental risks of carrying out work with alphavirus and flavivirus replicons at the stated containment levels are negligible.

1. Equipment Design in an Unregulated Environment - Welcome to the Wild West
   by Faye Litherland
2. A broad introduction to the design and construction of biosafety laboratories in low-resource settings
   by Mark Wheatley
3. Infectious sample transport: Evaluating the use of Parafilm™ for sealing primary containers
   by Jay Robinson
4. Biosafety aspects of activities of a high containment area for infectious diseases patients
   by Lucian Lereescu
5. US's Resilience and Contributions: Safeguarding Research and Community during the COVID-19 Pandemic
   by Suzette De Leon
6. Implementing Institutional Biorisk Management: Models, Metrics, and Impacts
   by Timothy Burke
7. Chromatography systems decontamination in multiuser laboratories is key to avoid unwanted biological agent release by Melanie Marchand
8. ow long does Mpox persist on stationary surfaces? 
   Risk assessment for the release of laboratory equipment or rooms from a BSL-3 facility - a scenario with Mpox by Katja Branitzki-Heinemann

Short presentations from the exhibitors so you know what to expect at their booths.

For the first couple of million years that humans existed, our distant relatives survived by hunting and gathering. Then, when the end of the last Ice Age brought a warmer, more stable climate about 12,000 years ago, communities in the Fertile Crescent began to experiment with agriculture. The transition from foraging to farming was a boon for infectious diseases. James C Scott, the American anthropologist, refers to the villages in which early farmers settled as “multi-species resettlement camps”. For the first time, humans lived cheek by jowl with animals and each other. This created unprecedented opportunities for zoonotic pathogens to jump from livestock to humans, and then to spread from person to person. Unsurprisingly, a variety of evidence – from the Yersinia pestis DNA found in 5,000 year old skeletons to the pockmarked bodies of Egyptian mummies – demonstrates that infectious diseases like plague, smallpox and many others first appeared in the wake of the move from hunting and gathering to settled agriculture. Ever since, pathogens have been the protagonists in many of the most important social, political and economic transformations in history.

Outbreaks of infectious diseases have destroyed millions of lives and decimated whole civilizations, but the devastation has created opportunities for new societies and ideas to emerge and thrive. Germs have played crucial but largely overlooked roles in: the growth of Christianity and Islam from small sects in Palestine and the Hijaz to world religions; the shift from feudalism to capitalism; and the devastation wrought by European colonialism; the emergence of the transatlantic slave trade; and the creation of the modern welfare state. We like to think that pathogens have much less of an impact on the modern world. It is true that advances in medicine and public health have allowed humanity to tame many of the infectious diseases that have devastated humanity since the shift from foraging to farming. Our species is not on the verge of winning the war against pathogens, however. Unprecedented growth in the world’s population, encroachment on animal habitats, industrial-scale factory farming, and ease with which we can travel between far-flung have combined to create the perfect conditions for new microbes to jump the species barrier and spread. We need concerted effort to tackle the threat posed by emerging infectious diseases.

Implementing biosecurity requirements in an academic environment, such as a university, presents a constant challenge. On one hand, this topic is often absent from university curricula, and on the other hand, many researchers are unaware of the rules and its implications. Because of their complexity, export controls and dual-use regulations can be overwhelming for many researchers. The scope of biosecurity is also very often underestimated, as it involves not only structural measures but also, for example, the publication of data or the exchange of scientific staff between research institutes. Researchers are very often left alone with their questions and lack a central, competent point of contact understanding biomedical research issues.

The presentation will discuss the challenges encountered in a university setting and provide an overview of the solutions implemented at the University of Bern, with a critical evaluation from a user's perspective.

Introduction

Sample and data management in high containment laboratories has to meet several biosecurity requirements. These include full traceability of generation, processing, and use of bio-samples as well as protection of data related to these samples such as pathogen sequences and experimental data, which goes hand-in-hand with the needs of proper biobanking information management system (BIMS) and advanced cyber security solution in compliance with international, European and national regulations, standards and guidelines.

Objectives

The aim was to establish a BIMS and high-end cyber security for a BSL-3(plus) laboratory for various biospecimens, i.e. human autopsy specimens, primary patient samples, high-risk pathogens, cell lines as well as pathogen sequence data and experimental data. The BIMS has to support a wide range of experimental workflows including sample collection and biobanking of tissues from human autopsies, processing of human swaps and serum samples, isolation and propagation of pathogens, sequencing of pathogens, investigation of pathogen-host interaction, virus neutralization assays in various in vitro models including cultures of human organ slices.

Material & Methods

The BIMS is based on the open-source, highly configurable biospecimen management system OpenSpecimen. Data entry forms of OpenSpecimen have been customized to the workflow in a high-containment laboratory with special emphasis on sample traceability. This work included the testing of labels and barcode scanners that work in a BSL-3 environment (i.e., to be properly used with PPE and resistant to various decontamination reagents). Based on users' input, the appropriate software tools are specified and data interchange protocols are defined. The architecture for a quality monitoring system and the secure storage and transmission of sequence data from high-risk pathogens, using a Shamir Secret Sharing encryption technology and Quantum Key Distribution protected connections have been developed. The work was performed in the context of the European Teaming project CY-BIOBANK and the project QCI-CAT of the EuroQCI initiative.

Results

OpenSpecimen was implemented in the BSL-3 laboratory at Medical University Graz and successfully tested in a wide range of research projects related to SARS-CoV-2 and other respiratory viruses. The OpenSpecimen implementation for biobanking of high-risk pathogens has been transferred to the biobanks of Cyprus (CY-BIOBANK). Open Specimen is currently extended from BIMS to be used for the management of pathogen sequence data.

The OpenSpecimen MySQL database is encrypted locally (at rest) by using Shamir Secret Sharing technology provided by fragmentiX. The Secret Sharing algorithm generates information-theoretic secure (ITS) data fragments that can be stored on different S3 storage servers. None of the data fragments contains any information that can be read by an attacker, and in case a server gets damaged a lost data fragment can be recovered from remaining fragments. For secure data transfer between storage servers and cooperation partners (security on transit), we are employing quantum key distribution using the Austrian national-wide quantum communication network that is currently established.

Conclusion

The adaption of OpenSpecimen BIMS that covers all processes from the collection of bio-samples containing high-risk pathogens to results from sample analysis can be made available as it is based on an open-source solution. Because of the sensitive nature of high-risk pathogen data it might be necessary to treat at least parts of the data as European Classified Information. Therefore, the required level of protection should be complemented by the use of strong hardened and protected user devices. These examples show how the use of advanced cybersecurity solutions may contribute to improve biosecurity in high containment laboratories.

Submit your proposal for oral presentation here

Biotechnology will be incremental in the process of achieving the UN sustainable development goals. At least 11 fields of biotechnology and 10 top molecular biology techniques have the potential to improve sustainable development according to the UN multi-stakeholder Forum on Science, Technology and Innovation with additional ones evolving regularly. As Jennifer Douda explained in her April 2023 TED-talk, CRISPR's next advance is bigger than you think. CRISPR has the potential to solve much of the methane production problem in dairy animals. But sustainable biotechnology is applicable in many more fields than agricultural biotechnology, i.e. human and veterinary medicine, bioremediation, astrobiology, electrobiology, synthetic biology, production of bio-based instead of petro-based products and energy generation. In all these exciting areas, assessment, mitigation and monitoring of biological and environmental risks are prerequisites for the sustainable use of these techniques and for the development of a sustainable bioeconomy. Not only has biotechnology to be environmentally friendly, but it has to be of true value for society including needs of indigenous populations of various corners of the globe. For these goals to be achieved, we need the integration of biosafety and biosecurity and the participation and interaction of competent biorisk management professionals in all areas of biotechnology. This presentation will cover various developments in biotechnology and how biosafety & biosecurity can support their safe and secure use.

Emerging at the intersection of life sciences and state-of-the-art Artificial Intelligence (AI) capabilities, biotechnological advancements are propelled, enhancing scientists' capacity to engineer living systems beyond conventional boundaries. Key AI tools in this transformative landscape encompass large language models (LLMs), bio-design tools, and AI-enabled automation within the life sciences. The rapid development of AI and its increasing convergence with the life sciences (referred to as AI-bio) unlock enormous potential for human health, transformative opportunities for pandemic preparedness, and the swift development of vaccines and therapeutics.

Despite the major advantages, AI tools within life sciences may be unintentionally or intentionally misused, posing a significant threat with the potential for a global biological catastrophe. Concerns about this upcoming AI tools in biotechnology are not only voiced by scientists but also by governments and the AI industry itself. Although revolutionary, the democratization of access amplifies the risk landscape, facilitating the manipulation of engineered micro-organisms by an expanding array of actors.

AI-bio prompts a critical inquiry into the biosafety, biosecurity, and dual-use implications of its capabilities. What are the multifaceted challenges and risks, and what are the potential solutions surrounding the convergence of AI and biotechnology to ensure responsible and secure progress?

Molecular biology laboratories regularly use plasmids carrying at least one antibiotic resistance gene for experimental purposes (selection of transformed bacteria based on their acquired resistance). After discovering bacterial taxa with unexpected resistance plasmids in the university's wastewater pipes, we hypothesized that naturally competent cells in the pipes had taken up undestroyed laboratory plasmids. We then demonstrated that not all biocides are effective DNA destroyers (for more details see: 10.1007/s11356-023-28733-0). Besides explaining the investigation methods used, the presentation will also consider adopting the basic preventive approach: avoiding the use of antibiotic-resistant plasmids in laboratories. Examples of alternative options will be presented.

The past pandemic crisis demonstrates how vulnerable our society has become to disasters caused by emerging diseases. In order to prepare for future incidents and outbreaks building, testing and implementing an incident management system is crucial. We proactively should have measures and incident response plans in place to prevent, respond to and mitigate incidents that involve biological agents which have the potential to cause harm to human, animal or plant health. Regularly training, drills, and continuous improvement efforts are essential for maintaining a state of readiness.

Bioremediation addresses the pressing issue of pollution caused by heavy metals, pesticides, hydrocarbons, pharmaceuticals and other contaminants. Organisms acting as natural bioremediators, provide a sustainable alternative to chemical and physical remediation methods.

In this break-out session, we introduce Nymphe, a European project dedicated to tackling environmental pollution by developing innovative bioremediation solutions. The ambition is to remove multiple pollutants (such as microplastics and pesticides in the agricultural soil, and chlorinated solvents and petroleum hydrocarbon in groundwater and sediments in the industrial area) from different contaminated sites in Europe, targeting at least 90% removal of the pollutants that are characteristic of the matrix to be depolluted.

To achieve these goals, Nymphe researchers develop bioremediation/revitalization strategies based on available and new biologics (enzymes, microorganisms, bivalves and earthworms, plants and their holobiont). Combinations of biologics will be assembled in bioremediation systems to be reimplanted in actual contaminated matrices.

While bioremediation holds the promise to be less intrusive and preserving delicate ecosystems, its success depends on responsible practices and adherence to regulations. When assembling complex microbial communities and/or working with organisms modified through modern genetic techniques, it will be challenging to make a robust risk assessment. During the break-out session participants will be invited to discuss their perspectives and thereby contribute to advancing safe application of bioremediation.

When working with genetically modified organisms (GMO) and/or pathogens, there are strict regulatory requirements defined by, amongst other, the 'contained use' legislation and Good Manufacturing Practices (GMP). One such requirement is the use of validated methods for the inactivation of these GMOs and pathogens. This is where the Biocides Regulation (BPR) comes in. However, for certain applications (e.g. parasite inactivation, disinfection of contaminated liquids, …), there are currently no approved biocides on the market. 

This breakout session on biocides focuses on the actions taken in the Netherlands and those taken by the EBSA taskforce BPR, including a survey amongst the members. Alongside, we will outline the timeline that the EBSA TF BPR and the Dutch BVF platform (BSO association), the Dutch ministry of Infrastructure and Water-management and the Dutch authorisation board for biocides together with the interest association of biocides producers (Biocides for Europe) are undertaking towards the European Commission in preparation for the refit of the BPR in 2025.

During the breakout session, the above will be explained in more detail, but there will also be plenty of opportunity to hear from our members if/where there are still issues regarding the use of biocides. The possible issues will be taken into account by the EBSA TF BPR in the route to the EC.

This breakout session will take a detailed look at Bowtie Analysis and how it can be applied to the Biosafety Industry to understand and effectively communicate the risks associated with the inadvertent or intentional release of dangerous pathogens.

A Bowtie Analysis is a visual risk management tool used since the 1990s, originally developed for and used in high hazard high consequence industries such as chemical, oil and gas, and aviation to communicate and present high hazard scenarios and demonstrate how the risk is being managed within an organisation.

During the last 15 years the Bowtie Analysis has proven it’s strength and versatility in the Biorisk management (BRM) area.

The breakout session will cover:

• Fundamentals of a Risk Assessment  
• Basics of a Bowtie Analysis
• A simplified Bowtie Analysis methodology
• A step-by-step demonstration of a Bowtie Analysis using a real-life industrial example.

The second half of the session will be an interactive session where delegates in groups can have a go at creating their own Bowtie Analysis using flipcharts and post-it notes before feeding back and discussing with their peers.

Delegates will leave the breakout session informed about the Bowtie philosophy and the effectiveness of presenting your risk assessments as a visual 'one pager’ to communicate your risk strategy to peers, stakeholders, and regulatory authorities.

This session is aimed at those organisations that handle and/or process hazardous pathogens in their facility, specifically aimed at those individuals who have a role in driving and implementing the safety strategy on site.

The past pandemic crisis demonstrates how vulnerable our society has become to disasters caused by emerging diseases. In order to prepare for future incidents and outbreaks building, testing and implementing an incident management system is crucial. We proactively should have measures and incident response plans in place to prevent, respond to and mitigate incidents that involve biological agents which have the potential to cause harm to human, animal or plant health. Regularly training, drills, and continuous improvement efforts are essential for maintaining a state of readiness.

Bioremediation addresses the pressing issue of pollution caused by heavy metals, pesticides, hydrocarbons, pharmaceuticals and other contaminants. Organisms acting as natural bioremediators, provide a sustainable alternative to chemical and physical remediation methods.

In this break-out session, we introduce Nymphe, a European project dedicated to tackling environmental pollution by developing innovative bioremediation solutions. The ambition is to remove multiple pollutants (such as microplastics and pesticides in the agricultural soil, and chlorinated solvents and petroleum hydrocarbon in groundwater and sediments in the industrial area) from different contaminated sites in Europe, targeting at least 90% removal of the pollutants that are characteristic of the matrix to be depolluted.

To achieve these goals, Nymphe researchers develop bioremediation/revitalization strategies based on available and new biologics (enzymes, microorganisms, bivalves and earthworms, plants and their holobiont). Combinations of biologics will be assembled in bioremediation systems to be reimplanted in actual contaminated matrices.

While bioremediation holds the promise to be less intrusive and preserving delicate ecosystems, its success depends on responsible practices and adherence to regulations. When assembling complex microbial communities and/or working with organisms modified through modern genetic techniques, it will be challenging to make a robust risk assessment. During the break-out session participants will be invited to discuss their perspectives and thereby contribute to advancing safe application of bioremediation.

When working with genetically modified organisms (GMO) and/or pathogens, there are strict regulatory requirements defined by, amongst other, the 'contained use' legislation and Good Manufacturing Practices (GMP). One such requirement is the use of validated methods for the inactivation of these GMOs and pathogens. This is where the Biocides Regulation (BPR) comes in. However, for certain applications (e.g. parasite inactivation, disinfection of contaminated liquids, …), there are currently no approved biocides on the market. 

This breakout session on biocides focuses on the actions taken in the Netherlands and those taken by the EBSA taskforce BPR, including a survey amongst the members. Alongside, we will outline the timeline that the EBSA TF BPR and the Dutch BVF platform (BSO association), the Dutch ministry of Infrastructure and Water-management and the Dutch authorisation board for biocides together with the interest association of biocides producers (Biocides for Europe) are undertaking towards the European Commission in preparation for the refit of the BPR in 2025.

During the breakout session, the above will be explained in more detail, but there will also be plenty of opportunity to hear from our members if/where there are still issues regarding the use of biocides. The possible issues will be taken into account by the EBSA TF BPR in the route to the EC.

This breakout session will take a detailed look at Bowtie Analysis and how it can be applied to the Biosafety Industry to understand and effectively communicate the risks associated with the inadvertent or intentional release of dangerous pathogens.

A Bowtie Analysis is a visual risk management tool used since the 1990s, originally developed for and used in high hazard high consequence industries such as chemical, oil and gas, and aviation to communicate and present high hazard scenarios and demonstrate how the risk is being managed within an organisation.

During the last 15 years the Bowtie Analysis has proven it’s strength and versatility in the Biorisk management (BRM) area.

The breakout session will cover:

• Fundamentals of a Risk Assessment  
• Basics of a Bowtie Analysis
• A simplified Bowtie Analysis methodology
• A step-by-step demonstration of a Bowtie Analysis using a real-life industrial example.

The second half of the session will be an interactive session where delegates in groups can have a go at creating their own Bowtie Analysis using flipcharts and post-it notes before feeding back and discussing with their peers.

Delegates will leave the breakout session informed about the Bowtie philosophy and the effectiveness of presenting your risk assessments as a visual 'one pager’ to communicate your risk strategy to peers, stakeholders, and regulatory authorities.

This session is aimed at those organisations that handle and/or process hazardous pathogens in their facility, specifically aimed at those individuals who have a role in driving and implementing the safety strategy on site.

Submit your proposal for oral presentation here

Proper disinfection and inactivation of highly pathogenic viruses is an essential component of public health and prevention. Depending on environment, surfaces, and type of contaminant, various methods of disinfection must be both efficient and available. To test both established and novel chemical disinfectants against risk group 4 viruses in our maximum containment facility, we developed a standardized protocol and assessed the chemical inactivation of the two Ebola virus variants Mayinga and Makona suspended in two different biological soil loads. Standard chemical disinfectants ethanol and sodium hypochlorite completely inactivate both Ebola variants after 30 s in suspension at 70 % and 0.5 % v/v, respectively, concentrations recommended for disinfection by the World Health Organization. Additionally, peracetic acid is also inactivating at 0.2 % v/v under the same conditions. Continued vigilance and optimization of current disinfection protocols is extremely important due to the continuous presence of Ebola virus on the African continent and increased zoonotic spillover of novel viral pathogens. Furthermore, to facilitate general pandemic preparedness, the establishment and sharing of standardized protocols is very important as it allows for rapid testing and evaluation of novel pathogens and/or chemical disinfectants.

How to decide on a decontamination strategy and select the most appropriate decontamination agents? A thorough literature review is the obvious method to use, but is it sufficient?

This podium presentation will walk the audience through a roadmap of surprises, considerations, and decisions concerning the often used phrase “well, the literature says it is so, then it must be true” to a culture of “trust, but verify”.

We will take you on tour and share our journey, the meetings, and the confusion and discussions that led us to the realization that there is only so much you can read and so much you can trust. We will discuss how we decided on appropriate decontamination strategies in a new production facility for Rabies and Tickborne Encephalitis vaccines by questioning the “the literature says that this works” and focusing on “this is what actually works in our production facility?”.

We work with large volumes of highly infectious material, and we have to get it right the first time. Decontamination of live active virus is of outmost importance. We will share with you our thoughts and discussions behind our validation study designs, including finding a laboratory that could assist us with the verification testing we could not do in-house, obtaining the first results and realizing what is written in the literature is not always what is true in real life. We will also share our thoughts and discussions about developing additional studies, revamping our decontamination strategy throughout our facility, and for the first time genuinely understanding our challenges on the production process. Ultimately, we were able to use the results from our validation studies to create a solid decontamination strategy with the most appropriate decontamination agents to minimize the risk of cross contamination in our multiple product GMP vaccine production while also keeping our production and maintenance staff and external service technicians safe when working with pathogenic agents.

The ability to insert genes into host genomes makes HIV1-based lentiviral vectors (LVV) a useful and common tool in research and medicine. A safety concern in the use of LVV is the formation of replication-competent lentivirus (RCL) though recombination as lentiviruses in general have a high recombination and mutation rate. Although the safety of LVV has been improved with each generation, by splitting up the essential HIV1 genes onto more plasmids, reducing homologous sequences and using self-inactivating (SIN) vectors, a theoretical potential for recombination remains. Another danger lies in (unintentional) mixing of different LVV types (different generations) and especially with wild-type HIV-1. To assess the potential risk of mix-ups and replication in laboratories using LVV, we collected LVV samples (plasmids, vector particles, cell supernatants) from public sources or obtained directly from research laboratories and tested them for their identity and the genes they contain. While we could not detect any recombination in the samples obtained, we found a high amount of contaminated LVV plasmids. Experiments with VSV-G carrying plasmids to trace the contaminations pointed to a general problem with centrifugation during DNA preparation. On top, the level of contaminations observed was sufficient to result in VSV-G pseudotyped LVV in otherwise VSV-G-free LVV packaging systems. Our experiments indicate that contaminations of as little as 0.32 nl of an average pMD2.G (popular VSV-G plasmid) Mini Prep (450 ng/μl) could have significant biosafety consequences if the contaminating plasmids lead to an accidental pseudotyping.