Integrated CRO Laboratory Services for Infectious Disease and Biopharmaceutical Development

Navigating Complexity in Infectious Disease Research

Infectious disease programs rarely move in a straight line. Pathogens behave differently across systems, assay requirements evolve as programs mature, and early-stage materials or methods may need to support decisions much later in development.

Microbiologics approaches CRO laboratory support as a scientific partnership. Our teams engage with your program objectives, not just the task list in front of them, helping you think through study design, biological materials, assay strategy, quality requirements, and the downstream implications of the data being generated.

Whether your work focuses on infectious disease research, biopharmaceutical development, diagnostic innovation, or public health preparedness, Microbiologics brings together specialized laboratory capabilities that help reduce complexity, maintain scientific continuity, and support confident decision-making throughout your program.

Reducing Complexity from Discovery Through Regulatory Submission

As infectious disease programs advance, laboratory work becomes more interconnected. A viral stock may become the foundation for assay development. Genomic data may inform strain selection, resistance analysis, or diagnostic performance. Documentation generated early in a program may become important during regulatory review.

When each component is handled by a different partner, methods may vary, documentation may not align, and scientific context can be lost between handoffs. Microbiologics brings multiple infectious disease capabilities together within one organization, helping reduce unnecessary complexity and support continuity from discovery through regulatory submission.

Discovery: Establishing the Scientific Foundation

Early-stage work shapes the decisions that follow. Microbiologics helps teams select and characterize biological materials, develop assay strategies, evaluate feasibility, and generate exploratory data that can guide the next stage of development.

Development: Scaling with Consistency

As programs mature, reproducibility, documentation, and scale become increasingly important. Microbiologics supports development-stage programs through connected expertise across virology, microbiology, genomics, assay development, and pathogen characterization, helping teams maintain consistency as studies expand and program needs evolve.

Clinical and Regulatory Support: Generating Traceable Data

Programs approaching clinical or regulatory milestones require standardized execution, controlled documentation, and data that can withstand scientific and regulatory scrutiny. Microbiologics provides qualified assays, GCLP-aligned testing options, quality oversight, full data traceability, and submission-ready reporting to support confident decision-making.

Infectious Diseases and Pathogens We Support

Microbiologics supports research and product development programs involving a wide range of viral, bacterial, fungal, and emerging infectious diseases. Our scientists work with organizations developing vaccines, therapeutics, diagnostics, and public health solutions for both established and emerging pathogens.

Areas of experience include:

• Respiratory viruses, including influenza, RSV, and SARS-CoV-2
• Emerging and re-emerging viruses, including Mpox, dengue, Zika, and avian influenza
• Bloodborne and persistent viruses, including HIV, HBV, HCV, HSV, EBV, and CMV
• Mycobacteria, including Mycobacterium tuberculosis
• Antimicrobial-resistant bacteria, including ESKAPE pathogens, Neisseria gonorrhoeae, and other clinically relevant organisms
• Fungal pathogens and organisms relevant to antifungal development
• Microbiome and live biotherapeutic product programs
• Viral safety and adventitious agent detection programs for biologics, vaccines, viral vectors, and cell and gene therapies

Frequently Asked Questions About Infectious Disease CRO Laboratory Services

What laboratory services are commonly needed for infectious disease research and development?

Infectious disease programs often require a combination of microbiology and virology services, microbial and viral stock production, assay development, pathogen characterization, genomics, antimicrobial or antiviral testing, immunogenicity assays, and, in some cases, BSL-2 or BSL-3 laboratory support. Microbiologics brings these capabilities together to support vaccine, therapeutic, diagnostic, biopharmaceutical, and public health programs from early research through development.

How do CRO laboratory services support vaccine development?

Vaccine development often requires well-characterized biological materials, immunogenicity assays, pathogen characterization, and data generated under established quality systems. Microbiologics supports viral and bacterial vaccine programs with microbial and viral stock production, antigen characterization, assay development, assay qualification, and immunogenicity testing, including HAI, microneutralization, NAI/ELLA, OPK, SBA, and ELISA assay formats.

What laboratory capabilities are important for antimicrobial and antiviral drug development?

Antimicrobial and antiviral development typically involves efficacy testing, mechanism of action studies, resistance profiling, microbial or viral stock production, and cell-based assays. Microbiologics supports these programs through antibacterial, antifungal, and antiviral testing, including MIC, IC50, EC50, TCID50, ddPCR viral load quantification, neutralization assays, and cell-based anti-infective assays.

How do CROs support infectious disease diagnostic development?

Diagnostic developers often need characterized reference materials, microbial and viral stocks, pathogen characterization, and genomic analysis to support assay development and performance evaluation. Microbiologics provides these capabilities to help strengthen confidence in diagnostic performance throughout development and validation.

When is BSL-3 laboratory support required?

BSL-3 laboratories are required for research involving pathogens that present a higher risk of aerosol transmission or serious disease and therefore require enhanced biosafety containment. Microbiologics operates BSL-2 and BSL-3 laboratories that support custom virology and microbiology studies, pathogen characterization, microbial and viral stock production, antiviral testing, immunogenicity assay services, and other research involving high-consequence pathogens.

How does Microbiologics differ from a traditional CRO?

Unlike general-purpose CROs, Microbiologics specializes in infectious disease and microbiology research. Our integrated capabilities span microbiology, virology, genomics, assay development, microbial and viral stock production, high-containment laboratories, and viral safety program support, allowing organizations to work with a single scientific partner across multiple stages of development.

Does Microbiologics support viral safety programs for biologics and cell and gene therapies?

Yes. Microbiologics supports viral safety programs for biologics, vaccines, viral vectors, and cell and gene therapies by providing purified and custom viral stocks, reference materials, NGS services, bioinformatics, and scientific expertise that support viral safety and adventitious agent workflows. While we do not currently perform full viral clearance studies or complete viral safety testing programs, our materials and analytical capabilities help customers generate the data and controls needed throughout development.

What pathogens does Microbiologics support?

Microbiologics supports research involving respiratory viruses, bloodborne and persistent viruses, emerging pathogens, antimicrobial-resistant bacteria, mycobacteria, fungal pathogens, and microbiome organisms. Areas of experience include influenza, SARS-CoV-2, RSV, Mpox, HIV, dengue, Mycobacterium tuberculosis, Neisseria gonorrhoeae, ESKAPE pathogens, and other clinically relevant infectious organisms.

What types of organizations does Microbiologics support?

Microbiologics partners with biotechnology and pharmaceutical companies, diagnostic manufacturers, vaccine developers, biopharmaceutical organizations, cell and gene therapy innovators, public health agencies, government organizations, and academic researchers advancing infectious disease and microbiology programs.

How do we get started working with Microbiologics?

The best starting point is a conversation with our scientific team. Share your program goals, current development stage, target pathogen or organism, and the laboratory challenges you are working to address. We'll help identify the capabilities, services, and scientific expertise that best align with your program.