Microbiologics Increases BSL-3 Lab Space to Meet Demand for Pathogen Testing Services
As scientific research into new treatments continues to grow, the need to effectively test and contain infectious agents is increasingly becoming a top priority. Biosafety Levels (BSL) have been established to rank pathogen risk from the lowest risk, BSL-1, to the highest risk, BSL-4. A significant amount of research is currently being done with pathogens ranked as BSL-3. The BSL-3 risk group includes pathogens such as SARS-CoV-2 (COVID-19) and Mycobacterium tuberculosis (MTB).
BSL-3 represents a pivotal juncture in the biosafety continuum, introducing heightened measures to address the challenges posed by infectious agents of moderate risk. Unlike the introductory confines of BSL-1 and the controlled environment of BSL-2, BSL-3 laboratories are designed to handle pathogens that can cause serious disease through inhalation, but for which effective treatments may exist.
Microbiologics, a leading infectious disease contract research organization (CRO), recently announced an expansion of their Biosafety Level 3 laboratory spaces at the company’s Global Virology Center in San Diego, California. The increased BSL-3 space is the first phase of a broader expansion of the San Diego location, signifying Microbiologics’ commitment to supporting their partners and sharing their expertise in virology and microbiology. Phase one focuses on increasing capacity for BSL-3 infectious agents, including high-throughput virology assay services as well as the production and inactivation of viral stocks for research use.
Facility Overview
Microbiologics’ mission is to create a safer, healthier world by providing the highest quality biomaterials. They take pride in helping their partners and customers across the globe create confidence in science. The Microbiologics team brings a consultative approach to each engagement, and they collaborate with each customer to build a custom program for their specific needs. This expansion allows Microbiologics to further pursue their mission, ensuring they are prepared to continue growing and supporting their partners’ needs as a leading CRO.
Microbiologics acquired and renovated a 43,000 square foot building near its original Global Virology Center in the Mira Mesa biotechnology area of San Diego. The new facility features multiple BSL-3 laboratory spaces spanning over 2,000 square feet, including a designated campaign suite for sensitive projects. BSL-3 laboratories are equipped with unidirectional air flow, biosafety cabinets, and antechambers to allow proper donning of personal protective equipment, including respirators.
“Demand for our BSL-3 services continues to grow, and limited laboratory space was soon going to constrain our ability to support the industry,” says Microbiologics Vice President of Research and Development, Brian Beck, Ph. D. “The new San Diego facility allows us to grow alongside our partners. We aim to be the approachable experts our partners can rely on throughout the drug development process,” Beck added.
Many times, commercial BSL-3 facilities lack the space to execute multiple projects or to work with more than one pathogen at a time. In total, Microbiologics’ new BSL-3 laboratories are 4X the size of the company’s previous BSL-3 space in San Diego. They also have additional BSL-3 certified laboratory space at their World Headquarters in St. Cloud, Minnesota. The company will be further expanding their offering to include pathogens from the CDC and USDA Federal Select Agents and Toxins Program in the future.
Safety Measures
As BSL-3 research involves high-risk pathogens, testing is performed in highly specialized laboratories under negative pressure, stricter PPE, and extensive administrative controls based on risk assessments that are performed for each pathogen and type of work.
Common BSL-3 safety controls include:
- The use of full-body PPE (Tyvek suits/coveralls), including goggles and double layer of gloves • The use of respirators to protect against possible respiratory exposure
- Sustained directional airflow (negative pressure) to draw air into the laboratory from clean areas toward potentially contaminated areas before being exhausted through HEPA filters (exhaust air cannot be recirculated back into the lab)
- Self-closing set of locking doors with access away from general building corridors
- Extensive security protocols and redundancies. Access to a BSL-3 laboratory is restricted and always controlled.
- Laboratory safety manual, risk assessments, and SOPs that designate how the work is performed safely
Full Range of Testing Services
The Microbiologics team is highly experienced with BSL-3 pathogens. They have deep expertise with respiratory agents, including SARS-CoV-2 and MTB, as well as other emergent threats like Avian Influenza and Mpox. They also support research for HIV and mosquito-borne pathogens such as West Nile Virus and Chikungunya. With multiple BSL-3 laboratories, a variety of high-throughput antiviral testing and custom manufacturing services are available for any BSL-3 agent.
Antiviral Testing Services
Antiviral testing methods evaluate if a compound has any effects on the virus’ ability to cause an infection. “The same way we know if a cell is infected, we can also observe the lack of infection if an antiviral is added to the cells,” says Beck. “To do this, we mix the virus with the inhibitor (drug or antibody) and test if the virus is neutralized and no longer infects the cells. We have many different assays in which to do this depending on the virus system being used. For example, for influenza viruses, there are several standard assays to assess impact of a vaccine or drug on different virus components and we perform those assays to give the client a full scope of the impact of their drug or vaccine.”
Since the start of the COVID-19 pandemic, Microbiologics has been at the forefront of providing SARS-CoV-2 biomaterials and assay services to support researchers and developers. They continuously source and produce the most relevant variants for monitoring immunological responses to vaccines and therapies, measuring PCR signal detection, and performing other critical research. With a highly specialized team and ample BSL-3 laboratory space, Microbiologics provides high-titer inactivated SARS-CoV-2 viral stocks and high-throughput custom assay services. Antiviral testing is done using advanced 3D cell system models, and studies can be performed to look for escaped mutants with a customer’s antiviral or therapeutic.
To stay current with the emergence of new viral strains, Microbiologics readily obtains any new variants or strains as they are available from biospecimen depositories to maintain an up-to-date virus inventory. Modern molecular biology techniques are used to create custom mutations in viruses that are identified by partners to test if the virus is becoming resistant to treatment.
Antibacterial and Antifungal Testing Services
Microbiologics has deep expertise in designing and executing antimicrobial drug screening programs that lay the groundwork for seamless regulatory submission. “We offer a wide range of standard and custom antimicrobial assays, advanced microbial identification, extraction and preservation, as well as strategic consulting services,” says Beck. “Our partners also gain access to our extensive biobank comprising more than 10,000 clinically important microbial isolates to test compounds against.”
Mycobacterium tuberculosis (MTB) is responsible for more deaths worldwide than any other infectious agent with 10.6 million new cases and 1.6 million deaths in 2022. In support of the ongoing battle against MTB, Microbiologics is ready to assist with primary and secondary profiling for the research and development of new MTB treatments. The company has validated broth microdilution susceptibility testing of MTB using custom frozen panels. These panels can be made to suit customer screening needs with any number of investigational compounds alongside relevant comparators. A variety of MTB strains are available for primary profiling, including susceptible and resistant isolates.
Viral Stock Production
Microbiologics has developed and optimized virus stock production methods for multiple BSL-3 pathogens and has a method to inactivate virus allowing others to work with the material under more accessible conditions. They employ numerous control measures to ensure the consistency and quality of their product. Their Global Virology Center in San Diego has received ISO 13485 certification for its BSL-2 and BSL-3 viral stock production methods. A panel of assays is performed to provide full characterization of the viral stocks they produce, ensuring their quality.
Assay Development
Developing assays for antiviral, antibacterial, and antifungal testing is crucial. Microbiologics’ approach to assay development is to ensure accuracy, sensitivity, and reproducibility of results.
“We have a proven record of success in navigating the anti-infective drug development process from discovery and development through clinical research and FDA review,” says Beck. “We offer standard and custom virology and microbiology assays and biomaterial services including advanced sequencing, propagation and reverse genetics. Our team is skilled in a variety of cell-culture based assays for the assessment of anti-infective compounds.”
Current Market Perspective and Future Plans
The demand for accurate and reproducible antiviral, antibacterial, and antifungal testing services is expanding. Microbiologics is continuously reviewing their capabilities and assessing market needs to ensure they will be able to effectively support their partners long-term. “Infectious diseases caused by viruses and bacteria continue to pose significant threats to public health,” says Beck. “Accurate testing is essential for diagnosing infections, determining the appropriate treatment, and tracking the spread of diseases. Our team is highly trained and flexible, allowing us to work with unique compounds, testing procedures, or pathogens that can be difficult to grow or test.”
Beck continues, “We strive to challenge ourselves to think ahead even of our partners. With the expansion planned, we are being purposeful in earmarking space to be available when and where our partners require our support for developing new technologies and treatments. Since we support custom requests, we have a tremendous amount of flexibility, more than most CROs. Our team brings a consultative approach to each engagement, and we collaborate with our partners to build a custom program for their specific needs. This means that we have a long history of taking on challenges and learning alongside our customers.”
Publication Detail
This article appeared in American Pharmaceutical Review:
Vol. 26, No. 8
Nov/Dec 2023
Pages: 64-66
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