Expertise Supports Public Health and Safety
Anthrax, botulism, and plague. Most people are familiar with these names but may not recognize the significant work it takes to keep these and other biological agents from posing a threat. As part of this work, our team at MRIGlobal develops custom pathogen detection panels, creating solutions that help maintain public health and safety.
Bio-Preparedness and Threat Detection
Bio-preparedness is a broad term that encompasses the comprehensive approach to managing biological threats starting with the early detection of those threats and then through the public health response.
This detection of emerging biothreats is a key component of bio-preparedness. However, organizations in need of these detection capabilities often cannot create such tools. In response to this need, MRIGlobal creates bespoke pathogen detection panels specific to each client and can take these panels though the entire lifecycle of development from initial conceptualization to creation, through validation, and final delivery.
Because emerging biothreats are an ever-present threat, it is important to maintain a surveillance and response network that is consistently challenged, ensuring it can sound the alarm when a threat is detected. Challenging that network requires a way to demonstrate that readiness maintenance and one means of this is through mock sample pathogen detection panels that simulate a real-world scenario. Our clients utilize the test panels produced by the scientists in our Integrated Health, Surveillance, and Diagnostics group to periodically challenge their surveillance networks. This not only assesses possible weaknesses that could be strengthened, but also demonstrates the competency of both the assays and involved laboratories, as well as their operational response and reporting to the simulated positive samples.
These panels encompass a wide spectrum of targets dependent on customer needs, including viruses, bacteria, toxins, extracted materials, surrogates, and antibiotic resistance markers. The panels can then be screened on multiple detection assays, from molecular, to immuno detection, to micro. MRIGlobal’s ability to develop and produce high consequence pathogen proficiency panels enables clients to tackle a broad array of challenges related to biosecurity, public health, and biodefense, thereby fortifying global preparedness against emerging threats.
Five Key Capabilities to Support Pathogen Proficiency Development
Our team develops these custom panels around the five key capabilities that support this development.
- Targets – We have the laboratories and expertise to handle targets that include whole organisms (bacteria and viruses), toxins, and extracted genomic material to meet almost all possible client assay needs. We also have experience using surrogate, or very closely related, organisms in lieu of highly pathogenic organisms.
- Shipping & Logistics – Shipping Risk Group 2 and 3 organisms or material requires specialty permitting and staff training. We hold an USDA APHIS permit and maintain staff IATA training to ensure that all shipping of potentially Dangerous Goods is done safely. We also have a dedicated packaging space that allows for large-scale shipment preparation, ad-hoc shipments, standing deliveries, or time sensitive delivery processing.
We often ship developed pathogen panels to clients for activities like process validation testing, which requires very specific materials, training, and permitting. We also often receive biological agents from partner institutions for the creation of these panels, which requires adherence to strict protocols.
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Facilities – We have more than 30 distinct laboratory spaces with strict titer flow, magnehelic air pressure monitoring, and dedicated clean and high-titer BSL-2 and BSL-3 designations. While some lab spaces are dedicated to long-standing clients, others have a variety of instrumentation and equipment that enables us to quickly adapt to new programs or requests. Basic research, spore productions, assay development, microbiology culture are just some of the things that we can do within this facility.
- Assay Types – While there are many different types of detection assays, they can be generally grouped into the following categories – molecular (namely PCR and sequencing), immunoassays, and classical microbiology. Regardless of assay mechanism, detection methods can be classified as either “known target” or “target agnostic” which each require a very different development processes. We have experience developing, validating, and deploying all of these assay types for various clients.
- Institutional Knowledge – Our staff carries decades of experience developing, validating, and delivering this type of work, which creates an institutional knowledge base to tackle almost any innovation or challenge. This knowledge base was built on past and on-going technical training for all staff levels and includes areas such as Select Agent experience, small to large scale production execution, and Quality and Compliance collaboration. Also, our long-standing positive client relationships help us quickly understand their needs and provide innovative solutions to the complex and important challenges they face.
Facilities and Expertise Support Customization
Our Gaithersburg, Md. facility has BSL-2 and BSL-3 laboratories that enable us to handle and test a wide range of pathogen targets that include Risk Group 3 agents. Additionally, we have the instrumentation necessary to perform microbiological tasks such as spore preparation, multi-condition incubators, and a dedicated biohazard material packaging space. Too, the proximity of this facility, as well as one in Arlington, Va., to Washington, D.C., allows for quick response times to emerging threats in the region.
Combined with longstanding client relationships, this breadth of capabilities means that we can translate customer needs into practical and scientifically sound solutions. We also have the support of a dedicated Quality Assurance team which enables us to track compliance across many different program and client requirements, assuring delivery of a quality final product.
Development of a Custom Pathogen Panel
With such a deep understanding of the most important pathogens, coupled with our experience working with all pathogen types, our team is well-equipped to properly execute projects that meet the exacting needs and specifications presented by our customers by producing high quality, scientifically sound deliverables.
Often, those customers are not scientists themselves, so rely on our team to propose well-rounded study designs to best achieve whatever their goals. When creating custom panels, the benefit of our expertise is demonstrated not only in the design, but also in the scientific integrity of their execution and the high-quality final deliverables we provide.
Regardless of the panel type, whether actual microbial organisms, assays, or data sets, we leverage our expertise, facilities, and staff to adapt to almost any challenge. Development of a custom pathogen panel usually follows one of two processes:
- When the client knows generally what they want on a whole organism panel, we will identify, source, and culture material to the requisite panel production scale, and then package and ship the panel to the identified recipients.
- When asked to develop a panel of detection assays, we are often given a whole-organism target and will then develop either molecular or immunoassays depending on the client request. These assay panels can be single-plex (one target) or multi-plexed (multiple targets). For newly developed assays, we can also determine their specificity and sensitivity, and have a range of established study designs that can be adapted to meet client needs.
MRIGlobal’s wide array of capabilities are primed to create custom solutions from development to delivery for high consequence pathogen detection. These solutions enable clients from all sectors to solve challenges in every aspect of pathogen detection, which helps maintain public health and safety.
