In the world of vaccine and antiviral development, access to high-quality, reliable viral reference materials can make or break a research program. Yet, few outside the industry understand how these critical reagents are manufactured, or by whom. When most people imagine a manufacturing facility, they envision assembly lines, industrial machinery, and perhaps the occasional whir of robotic arms. What they probably don’t picture is a highly specialized team working together to produce infectious viruses. But that is exactly what we do at Microbiologics, and we do it exceptionally well.

Specialized GMP Virology Manufacturing for Scientific Advancement

At Microbiologics’ Global Virology Center in San Diego, CA, we specialize in the production of both infectious and inactivated viral and bacterial materials. These biological standards are critical to advancing research, diagnostic assay development, pharmaceutical quality control, and more. Whether supporting vaccine development or assay validation, we understand the significance of each and every aliquot we produce.

Our GMP compliant viral manufacturing processes span a broad portfolio of wild-type and recombinant strains, including a wide range of enveloped and non-enveloped viruses. Supported by stringent quality systems that meet regulatory expectations for pharmaceutical and diagnostic development, we maintain a diverse in-stock inventory, including highly requested pathogens such as Influenza, RSV, Adenovirus, and SARS-CoV-2, HIV, and Arboviruses. We implement Good Manufacturing Practices and maintain ISO 13485 and GLP/GCLP frameworks to ensure product consistency, safety, and traceability across all production stages.

While many partners rely on our off-the-shelf viral and bacterial materials, we also offer highly customized production services. From upstream seed banking to downstream purification, inactivation, and titration, every step is executed with scientific precision and documented under stringent quality systems to ensure reproducibility and regulatory readiness.

High Impact Scientific Expertise and Agile Viral Stock Production

Our San Diego site is purpose-built for virological production and is operated by a dedicated team of scientists and production specialists. Each team member brings expertise in virology, cell culture, and process development. We also collaborate closely with our Custom Research and Assay Services teams to ensure each project aligns with both end-use and regulatory goals.

We consistently outperform larger organizations in agility, responsiveness, and customization. This strength allows for rapid decision-making and efficient project turnaround time. Direct engagement with our scientific and business development team ensures results.

Flexible Large-Scale Cell and Egg-Based Virus Propagation

At Microbiologics, we recognize that no single propagation system fits all viruses or scientific needs. Our production capabilities include both advanced cell-based culture systems and traditional egg-based methods, allowing us to select the optimal host environment for each viral strain.

For cell-based propagation, we maintain a wide range of mammalian and insect cell lines, both adherent and suspension, to support efficient viral growth under controlled, reproducible conditions. We maintain a wide range of expertise in both enveloped and non-enveloped viruses and routinely tech transfer and optimize production processes.

In addition, we offer egg-based propagation using embryonated chicken eggs—an established gold standard for influenza and other select viruses. This method leverages the unique biology of the egg to support high-yield viral replication, particularly when certain strains require conditions not easily replicated in vitro.

To support diverse project needs, we offer custom-scale production ranging from a few hundred milliliters to over 50 liters, enabling right-sized viral stock manufacturing for applications from research to clinical development.

By offering both systems, Microbiologics provides unmatched flexibility in custom viral stock production, enabling us to meet diverse research and manufacturing needs with precision and speed.

Viral and Cell Banking Services

Our capabilities include custom viral stock generation using strains from our own collection or partner-provided seed materials. We also establish and store high-quality seed stock for recurring or long-term use.

Production is supported at BSL-1, BSL-2, and BSL-3 levels, with scalable platforms in both adherent and suspension cell culture systems. Aliquots are available in a wide range of volumes, from as small as 10 µL to over 1 liter, to suit your specific application.

Quality control capabilities include:

• TCID₅₀
• Plaque assays
• ddPCR
• Genetic sequencing
• Hemagglutination
• Sterility
• Protein determination
• Endotoxin testing
• Mycoplasma testing
• Stability studies
• Purity testing

We also offer tech transfer of production and quality control methods to reduce variability and align output with your internal workflows. Inactivation is performed using validated methods such as heat, UV, gamma irradiation, and chemical treatment, depending on project needs.

In addition, our cell banking services support long-term, traceable development programs:

• Establishment of master and working cell banks
• Full traceability and characterization documentation
• Custom freeze media and cell concentrations
• Cryogenic storage options for recurring or project-specific use

We understand that repeatability and consistency are essential. Some of our most frequently requested quality controls include sterility testing, identity confirmation via bidirectional or whole genome sequencing, and titer verification. Each batch is accompanied by a comprehensive Certificate of Analysis to support transparency and regulatory compliance.

Scientific Collaboration That Drives Success

We view our customers as partners in a shared scientific mission. Each engagement begins with a detailed technical consultation to define project scope, deliverables, and intended use. From there, our team works in close alignment with our partner’s scientists to ensure precision, efficiency, and regulatory success.

Key elements of our collaborative approach include:

• Collaborative Project Management: Business development managers work alongside scientific leads to ensure all requirements are met from start to finish.
• Routine Communication: For complex or multi-phase projects, bi-weekly technical updates and milestone reviews ensure transparency and flexibility.
• Post-Delivery Support: Our scientists and business development managers remain available for ongoing technical consultation, whether a question arises a week or a year after delivery.

At Microbiologics, our focus on scientific rigor, clear communication, and long-term collaboration forms the foundation of everything we do. Through a combination of technical expertise, quality-driven manufacturing, and flexible project execution, we aim to provide researchers with the reliable viral materials they need to drive forward the development of life-saving therapies and diagnostics.

Special thanks to Afsaneh Kharazmi, Manufacturing Project Lead at Microbiologics’ Global Virology Center, for her contributions to this article and her leadership in viral stock production.

Looking for a partner in custom viral stock production?

Learn more about our capabilities, quality systems, and custom services designed to meet your research needs at Microbiologics.com.