Getting to Know Agilent Technologies: Sterile Processing and Infectious Disease Research

Infection Intel: Staying Ahead with Company Updates and Product Innovations

Countless companies work on improving our lives through research in infectious diseases and prevention. To discover what one company, Agilent Technologies, contributes to the infectious disease and sterile processing fields, Infection Control Today^® (ICT^®) interviewed Aimee Chiavario, global biopharma segment manager for Agilent Technologies.

Infection preventionists and other personnel involved in infection prevention are hands-on workers who need to know about ongoing and wide-ranging research being conducted behind the scenes to perform their roles safely and effectively.

ICT: Can you elaborate on Agilent's role in supporting scientists globally and its impact on cutting-edge life science research, patient diagnostics, and the testing of water, food, and pharmaceuticals?

Aimee Chiavario: Agilent is a leader in life sciences, diagnostics, and applied chemical markets. We provide laboratories worldwide with instruments, services, consumables, applications, and expertise, enabling customers to gain the insights they seek. Our mission is to advance quality of life by focusing our expertise in 6 key markets, including life science research, diagnostics, pharmaceuticals, food, environmental, and chemicals/advanced materials. With a team of approximately 18,000 employees worldwide, our global footprint enables us to deliver high-quality solutions to our valued customers in 110 countries.

Aimee Chiavario

ICT: Given Agilent's diverse areas of focus, particularly in infectious diseases, how does the company contribute to advancements in this field, and what innovative solutions does it offer to address current challenges?

AC: Agilent offers unique and comprehensive analytical solutions to help our customers advance infectious disease research and therapeutic development:

• Testing integrity of in vitro transcribed RNA vaccines
  Using automated parallel capillary electrophoresis, Agilent’s Fragment Analyzer system helps researchers analyze DNA and RNA fragments for a range of applications, including IVT RNA. In the early days of the COVID-19 pandemic, Pfizer researchers were tasked with optimizing and implementing good manufacturing procedures (GMP) for the IVT RNA Pfizer-BioNTech COVID-19 vaccine. RNA integrity is a critical component to ensure a safe and efficacious dose of the vaccine is provided.
  https://www.agilent.com/cs/library/casestudies/public/casestudy-in-vitro-transcribed-rna-vaccines-fragment-analyzer-5994-5251en-agilent.pdf
• SARS-CoV-2 wastewater analysis
  Researchers at Weck Laboratories developed a qRT-PCR-based SARS-CoV-2 test for wastewater using Agilent RNA purification kits, qRT-PCR reagents, and instrumentation. The assay reliably determined SARS-CoV-2 viral RNA levels in various raw wastewater samples with high sensitivity (observed as low as 8,000 viral genome copies per liter of wastewater).
  https://www.agilent.com/cs/library/applications/Application-wastewater-analysis-qRT-PCR-SARS-CoV-2-5994-2875EN-agilent.pdf
• Enabling whole genome sequencing of viruses and bacteria directly from clinical samples
  Agilent SureSelect target enrichment enables highly efficient whole pathogen genome sequencing without prior culture or PCR. A research group led by Professor Judith Breuer, FMedSci, at University College London, has pioneered the enrichment and sequencing of whole pathogen genomes directly from clinical research material using custom SureSelect NGS panels.
  https://www.agilent.com/cs/library/applications/infectious_APP5994-0909EN.pdf
• Serological assays for viral detection
  Florian Krammer, PhD’s laboratory at the Icahn School of Medicine at Mount Sinai, developed a serological assay to investigate SARS-CoV-2 using BioTek’s 405 LS Microplate Washer and a Synergy Hybrid Multi-Mode Reader, which later received authorization for emergency use from the US Food & Drug Administration (FDA).
  https://www.agilent.com/en/solutions/customer-stories/covid19-infectious-diseases/creating-a-serological-assay-for-the-investigation-of-sars-cov-2
• Analysis of cellular immune response, cytopathic mechanisms, and viral titration
  Automated viral cytopathic effects, viral plaque, and TCID50 assays can be performed using kinetic live cell imaging and powerful image analysis tools, including the Cytation Imaging Multi-Mode Reader and Lionheart FX Automated Microscope. Christopher Aiken lab members at Vanderbilt University are using the Agilent BioTek Cytation to determine infection levels of human immunodeficiency virus (HIV) with HeLa cells in culture.
  https://www.agilent.com/cs/library/applications/monitoring-viral-infection-HIV-5994-2542EN-agilent.pdf
• Automated scoring of acid-fast bacteria by fluorescent smear microscopy
  Some human and livestock diseases are caused by bacterial strains in the genus Mycobacterium, which are identified using acid-fast staining assays. Microscopy methods are used as part of a screening process to identify presumptive AFB-positive samples of those potentially exposed. An automated microscopy and analysis protocol using Agilent BioTek Lionheart FX automated microscope is an alternative method to increase accuracy and reproducibility over manual scoring.
  https://www.agilent.com/cs/library/applications/automated-scoring-AFB-5994-2546EN-agilent.pdf
• Rapid, high throughput screening of virus-neutralizing antibodies
  Agilent’s xCELLigence Real-Time Cell Analysis platform provides highly sensitive and quantitative measurements of viral cytopathic effects. This technology can be used to measure virus titers and high-throughput screen virus-neutralizing antibodies. Vanderbilt University Medical Center—James Crowe Laboratory researchers used this technology to discover highly potent neutralizing antibodies against the SARS-CoV-2 Spike protein.
  https://www.agilent.com/en/solutions/customer-stories/covid19-infectious-diseases/vanderbilt-vaccine-center
• Investigating host metabolism in respiratory viral infections
  Seahorse XF technology measures the two major metabolic pathways, glycolysis and mitochondrial respiration, providing insight into host-pathogen interaction, innate immune response to infection, and potential therapeutic targets. Heather Smallwood, PhD, at the University of Tennessee Health Science Center, uses the Seahorse XF system to investigate host metabolism in respiratory viral infections to address issues with vaccine and therapeutic development.
  https://www.agilent.com/en/solutions/cell-analysis/cell-metabolism/host-pathogen-metabolism
• Immunophenotyping, cytokine assessment, bacterial cell counting, and viability
  Novocyte flow cytometers provide robust, sensitive, and automated quantitative assays relevant to infectious disease research, including host response to pathogens.
  https://www.agilent.com/cs/library/applications/application-neutrophil-phagocytosis-novocyte-5994-1024en-agilent.pdf
  https://www.agilent.com/cs/library/applications/an-cytokine-production-on-NovoCyte-Penteon-5994-4033en-agilent.pdf
• Quantification of gut microbiota-derived metabolites
  Interest in the role of the human gut microbiota in health and disease research has created a demand for quantifying community-derived metabolites. This highly reproducible and robust ion-pair reversed-phase (IP-RP) dynamic multiple reaction monitoring (dMRM) method using Agilent 1290 Infinity II LC and 6470A triple quadrupole LC/MS provides efficient separation of over 200 central carbon metabolites.
  https://www.agilent.com/cs/library/applications/application-metabolite-quantitation-dMRM-database-and-method-5994-1254en-agilent.pdf

Infection Control Today's Topic of the Month for April: Celebrating Sterile Processing

ICT: In the context of sterile processing, can you share Agilent's approach to ensuring the reliability and accuracy of results in the testing of water, food, and pharmaceuticals, considering the global scale and diverse environments involved?

AC: Agilent ensures the reliability and accuracy of results in testing water, food, and pharmaceuticals by providing high-quality instruments and trusted solutions. Maintaining sterility is important to ensure that the products are free from viable microorganisms that can cause harm to human health. Various methods and technologies can be used to ensure sterility, including:

• Bacterial endotoxin testing
  FDA regulations require that raw materials used in parenteral drugs be tested for endotoxin levels. Agilent BioTek Absorbance Readers are proven platforms for performing bacterial endotoxin LAL assays. Bacterial endotoxins are lipopolysaccharides (LPS) generally found in the outer membrane of gram-negative bacteria, such as Escherichia coli. They are widely present in our environment and cause human effects ranging from fever to hemorrhagic stroke.
  https://www.agilent.com/en/solutions/cell-analysis/toxicology-research/endotoxin-analysis-lal-assay
• Monitoring the growth of bacteria
  The BioTek LogPhase 600 microbiology reader is designed for measuring microbial growth curves in up to four standard 96-well microplates. This microbiology plate reader features purpose-built robust shaking and consistent temperature controls, which are critical to optimal bacteria and yeast cell growth.
  https://www.agilent.com/en/product/microplate-instrumentation/microplate-readers/multiplate-absorbance-reader/biotek-logphase-600-microbiology-reader-1623185
• Bacterial detection in food
  Foodborne illness traced to fruits and vegetables has increased research on methods for ensuring end-product safety. The Agilent BioTek ELx800 absorbance microplate reader and BioTek ELx50 microplate strip washer are used in a low-cost semi-automated method to detect Escherichia coli O157:H7, Listeria monocytogenes, and Salmonella enterica Typhimurium from a 5% organic load of lettuce wash.
  www.agilent.com/cs/library/applications/concentration-detection-lettuce-wash-5994-2547EN-agilent.pdf
• Bacterial detection in environmental water
  NovoCyte flow cytometers provide a high sensitivity of detection for detecting and analyzing microbes in environmental water. Traditional bacterial identification methods are based on observations of the morphology of single cells or colony characteristics when grown on agar. However, the microbes grown on an agar medium with visible colonies are less than 1% of the total, and most bacteria, though present and active, are not efficiently cultured.
  www.agilent.com/cs/library/applications/application-detection-bacteria-environmental-waters-novocyte-5994-2114en-agilent.pdf
• Evaluating bacterial biofilms
  Bacteria prefer to live a communal lifestyle encased in a 3D extracellular matrix composed of a mix of extracellular polymeric substances (EPS). These bacterial biofilms are responsible for human and livestock diseases and can cause industrial air and water handling systems fouling. Agilent offers several in vitro methods to study biofilm systems, including biochemical, imaging, and cellular impedance assays.
  www.agilent.com/cs/library/applications/an-efficacy-of-confocal-imaging-reader-bacterial-biofilms-5994-6764EN-agilent.pdf
  www.agilent.com/cs/library/applications/application-bacterial-biofilms-xcelligence-5994-1065en-agilent.pdf

ICT: Following our previous conversation, have there been any notable developments or advancements in Agilent's technologies, instruments, or services related to sterile processing, and how do these contribute to optimal scientific, economic, and operational outcomes?

AC: Agilent’s latest portfolio of high throughput cell analysis tools enables the assessment of microbial growth, infection, and endotoxins in samples. These methods allow researchers to understand the underlying mechanisms that cause infectious disease and microbial contamination of food, environmental water, and industrial facilities. Additionally, Agilent CrossLab integrates services and consumables to support workflow success, improve productivity, and enhance operational efficiency. This wide range of products and services—from method optimization and training to full-lab relocations and operations analytics—helps laboratories manage their instruments for best performance.

Agilent CrossLab also helps labs reach their sustainability goals by disposing of used parts and packaging in an earth-friendly way with Agilent Green Recycling and extending instrument life to keep equipment out of landfills with proper routine maintenance.

ICT: Considering Agilent's presence in 110 countries, how does the company navigate and adapt to the regulatory landscapes and diverse requirements in different regions regarding sterile processing and ensuring the safety and quality of products in life science research and diagnostics?

AC: Today, regulatory bodies around the globe conduct more frequent audits, including the FDA, the European Medicines Agency, and Japan’s Pharmaceutical Development and Management Association. Agilent recognizes how this impacts customers. Agilent has developed systems, software, and services that integrate seamlessly and work together to handle these challenges confidently. Agilent’s CrossLab compliance consulting services are focused on critical areas such as computer system validation (CSV) for GAMP5 (risk-based approach and V model) and part/annex 11 (electronic records and signatures), audits/assessments for data integrity, and custom procedure writing. An example of custom procedure writing is helping laboratories comply with the 2017 USP <1058> for AIQ.
www.agilent.com/en/solutions/biopharma-pharma/compliance-support-services
www.agilent.com/en/service/laboratory-services/compliance-services/compliance-consulting