Microbiology Testing Services

Our biomedical scientists and engineers offer bespoke identification and characterization of microorganisms like bacteria, fungi, and yeasts, frequently applying combinations of methodologies and developing novel approaches depending on sample complexity, the specific industry or application, from pharmaceuticals to food safety and more, and other factors. Our multidisciplinary teams can help clients identify specific organisms of interest, potential contaminants, and microorganisms that could compromise product sterility.

Our microbiological experts provide customized antibiotic susceptibility assay development and validation, often involving the creation of novel test methods or the modification or combination of existing ones to address unique challenges, such as testing rare pathogens or evaluating antimicrobial products that don't fit standard testing protocols. Our consultants provide data generation and reporting support for complaint analysis, CAPAs, and regulatory submissions, perform post-market surveillance, and offer guidance across the entire product lifecycle.

Exponent's biomedical engineers and scientists provide rigorous quality assessment and risk analysis to evaluate the efficacy of antimicrobial coatings and materials and tailored disinfection protocols for medical devices and consumer products.

Exponent's biomedical, health science, and industrial hygiene experts provide rigorous quality assessments and risk analysis to evaluate the risks of microbiological contamination in consumer products, medical devices, and manufacturing lines. We can perform root-cause analyses of microbiological contaminations (viral, bacterial, or fungal) and frequently support clients in related disputes, providing objective, data-driven analyses and science-based court testimony.

Our IVD consultants provide wide-ranging support for in vitro and companion diagnostics, spanning high-throughput clinical labs, point-of-care, and at-home testing products. Our capabilities include real-world evidence (RWE) analysis, identification of IVD safety risks such as use-related errors, assay and instrument development, and expertise in human factors, chemical, biological, mechanical, electrical, and materials considerations. We also offer support for microfluidics, disposables, and technical due diligence, delivering holistic solutions for diagnostic development and deployment to our clients.

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When testing solutions and investigations beyond standard protocols, rely on Exponent's custom unmatched expertise and state-of-the-art molecular biology laboratory.

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Microbiology testing involves the identification, characterization, and analysis of microorganisms — such as bacteria, fungi, and yeasts — that may be present in various samples. Identification and root-cause analysis of contamination in medical devices and consumer products with rapid response times helps to limit potential injury and speed remediation efforts. This testing is also critical for industries like pharmaceuticals and food safety because it helps ensure product sterility, prevent contamination, and safeguard consumer health. By detecting and identifying potential pathogens or spoilage organisms, companies can maintain regulatory compliance, avoid product recalls, and improve the overall quality and safety of their products.

Exponent scientists support contamination investigations by performing root-cause analyses to identify sources and pathways of microbial contamination, whether viral, bacterial or fungal. Our experts offer objective, data-driven assessments and risk analyses, often supporting clients during disputes or regulatory inquiries. We offer clients actionable solutions to prevent recurrence, maintain product quality, and meet industry standards.

Exponent offers a wide range of assays and analyses, including bespoke identification and characterization of microorganisms, antibiotic susceptibility testing, antimicrobial material efficacy testing, and contamination investigations. These services are tailored to address specific challenges, such as testing rare pathogens, validating disinfection protocols, and supporting CAPAs and regulatory submissions. Our multidisciplinary teams frequently develop novel methodologies or modify existing ones to suit unique industry requirements and sample complexities.

Our scientists and engineers validate the effectiveness of antimicrobial coatings and disinfection protocols by conducting rigorous quality assessments and risk analyses. These evaluations involve standardized and customized tests to measure the ability of coatings or protocols to reduce or eliminate microbial presence on surfaces or devices. The process often includes simulating real-world conditions and analyzing outcomes to advance both efficacy and safety, providing data-driven recommendations for both product development and regulatory compliance.