Choosing a virology services provider is often framed around tangible transactional capabilities, virus stock inventory, assay panel availability, or specialized techniques. But experienced service teams know that technical execution is only as strong as the quality systems supporting it. Impure lots, incomplete testing packages, or missing documentation can delay regulatory submissions and derail timelines.

When selecting a virology service provider, it is easy to primarily focus on the virus stock or assay capabilities a potential partner has, the tangible elements necessary to execute a part of the larger clinical strategy. But any project manager will tell you that product execution can be positively or negatively impacted by the quality methods, testing, and documentation behind the product. Tight project timelines can be stretched or even broken by impure samples, gaps in testing and certification documentation, or lack of internal bandwidth to execute the necessary paperwork for an FDA filing. In practice, aligning laboratory execution with robust quality systems and clear documentation early in a project reduces downstream risk and supports regulatory readiness.

Inactivation Techniques for Safer Research

Many researchers prefer or even require inactivated virus preparations to support work under lower biosafety conditions. In regulated manufacturing environments, this flexibility must align with stringent safety and regulatory requirements. Although multiple inactivation methods exist, selecting the appropriate approach for each virus and downstream application requires experience. To ensure safety, best practice includes 100% lot-specific verification of residual infectivity using validated cell-based assays.

There are three primary techniques commonly used to inactivate viruses to reduce infectivity to lower biosafety levels:

• Beta-propiolactone (BPL). BPL is a widely used chemical inactivation method that preserves antigenic structure and is effective across virus families. When applied under controlled conditions, BPL has been shown to effectively inactivate both DNA and RNA high titer viruses while preserving key structural features. Additionally, it alters the capability of residual/contaminating cell DNA to be used as template by various polymerases.
• Heat Inactivation. Heat inactivation can be effective for certain viruses, particularly when sensitive genomic integrity must be preserved. Thermal inactivation is typically performed at specific temperatures and times points suitable for different virus types; however, this method is not as efficient or successful for all viruses as compared to BPL. Careful evaluation is required to ensure the appropriate inactivation approach is selected for a given research application.
• Custom Inactivation. There are other inactivation methods, such as formaldehyde or ether, that may be appropriate depending on the virus and downstream research needs.

Depending on the process requirements, it is critical to collaborate with clients to understand their downstream application and provide recommendations to meet their research and safety needs.

Purification, Concentration, and Processing of Biomaterials

For applications that require viral stocks with higher viral concentrations, accuracy, reproducibility, safety, reduced toxicity, or where appropriate reduced immunogenicity, additional processing and purification approaches can be applied. By integrating multiple processing and purification strategies with rigorous quality control, product performance can be enhanced while maintaining high yields and supporting scale requirements.

Common purification workflows include filtration, precipitation, and ultracentrifugation methods to eliminate contaminants while maintaining high yields of the viral target.

Some of the benefits of high purity biomaterials are:

• Vaccine Development. Purified viruses are less likely to contain toxins or host cell proteins that could cause adverse reactions. Purified viral preparations minimize residual host-cell proteins and nucleic acids that can often influence the immune response or introduce unwanted variability. It also ensures the immune system targets the virus target of interest and not any impurities present.
• Diagnostic Assay Development. Purified viruses are the go-to for viral reference standards for calibration and validation of diagnostic tools like NGS, PCR, ELISA, or lateral flow tests. High purity ensures consistent target genome and antigen content, enabling accurate calibration, sensitivity assessments, and improved lot-to-lot reproducibility.
• In-vivo Studies. Purified virus prep reduces toxicity from contaminants like endotoxins from bacterial or cell cultures that can skew the targets immune response or even kill the animal models, disrupting research and costing valuable time and money. Purified virus preparations reduce contaminants such as endotoxins, host-cell debris, and media components that can trigger non-specific inflammation, alter immune readouts, and even severe inflammatory reactions or morbidity in animal models. Clean material supports clearer interpretation of results and reduces the risk of study disruption.

Deliberate purification and processing strategies are critical to minimizing host and process related contaminants such as host-cell proteins, endotoxins, and cellular debris. Yielding viral materials that are safer, more consistent, and suitable for highly sensitive applications. High-quality, well-characterized biomaterials are essential for reliable assay performance, accurate biological interpretation, and successful translation from research through development.

Certificate of Analysis (COA)

A Certificate of Analysis is an essential document in maintaining the quality and safety of products across numerous industries. Rather than serving as a simple formality, a COA functions as a lot-specific record of test results, production details, and quality review that supports traceability and regulatory expectations.

A well-constructed Certificate of Analysis provides critical details regarding the safety, quality, and characterization of our final product, including the following sections:

• Product Identification. Product description, unique lot number, biological product classification, and any other relevant information that ensures traceability.
• Biosafety Level. Biosafety level of the viral target contained in prep.
• Production Method. General methods used to produce or process the viral prep as well as any additive reagents and final formulation.
• Test results. Includes standard testing such as infectious titer, genomic copy number, Hemagglutination titer, and sterility report where appropriate. Additional testing can be included, such as Endotoxin, Mycoplasma, and Whole Genome or Sanger sequencing reports.
• Approval and Signature. Each COA is reviewed before it is signed and approved by the Director of Virology Operations or Virology Services, certifying the accuracy of the document and the data reported.

Together, these elements allow research teams to evaluate material suitability and support quality review and regulatory submissions.

Quality Systems

In today’s tightly regulated life sciences landscape, maintaining robust quality systems is not optional, it’s essential. From pharmaceutical manufacturing to medical device development and laboratory testing, companies must adhere to established frameworks that ensure product safety, data integrity, and regulatory compliance. Key among these frameworks is Good Manufacturing Practices (GMP), an ISO 13485 certification, and Good Laboratory Practice (GLP)/Good Clinical Laboratory Practice (GCLP), particularly as outlined in 21 CFR Part 58.

Each standard serves a distinct purpose, but together, they form the backbone of a compliant and reliable quality management system (QMS) that supports:

• Product safety and effectiveness
• Data reliability and traceability
• Successful regulatory audits and submissions

Organizations that proactively implement and maintain these standards reduce the risk of regulatory findings, safeguard their reputations, and demonstrate a strong commitment to patient and consumer safety. Across applications, strong quality systems help ensure consistency, defensibility, and long-term reliability.

Elevating Confidence Through Inactivation, Purity, and Compliance

The integrity of your research depends on the quality of the materials you use. When viral stocks are inactivated, highly purified, and documented under robust quality systems, you reduce variability, protect your models, and support regulatory acceptance. Prioritizing transparency and scientific rigor at each step help research teams manage risk and support confident decision-making.

Translating Quality Standards into Research-Ready Viral Materials

Reliable viral research depends on more than technical capability. It requires carefully selected inactivation methods, strategic and well-controlled purification processes, and documentation supported by robust quality systems.

Microbiologics brings these elements together through custom preparation services and off-the-shelf viral stocks designed to support regulated research and development.

Visit our website to reach out and learn how we can help you meet your goals with confidence.

About the Authors

Shannon Orias

Shannon Orias is the contract manufacturing and operations leader at Microbiologics, specializing in virus manufacturing. She thrives at the intersection of science, quality, and operational efficiency—ensuring tight turnaround times, regulatory compliance, and cross-functional alignment in a high-stakes environment. With over 10 years of experience supporting pharmaceutical, diagnostics, and research partners, she brings proven expertise in delivering high-quality virus solutions with speed and precision.

Afsaneh Kharazmi

Afsaneh Kharazmi is a Manufacturing Project Lead at Microbiologics’ Global Virology Center, bringing more than 12 years of biotechnology industry experience and deep expertise in quality control and virology. In her leadership role, she provides strategic oversight of end-to-end viral production programs spanning diverse viral strains, leveraging advanced tissue culture technologies to ensure consistency, scalability, and strict adherence to quality standards. She directs complex manufacturing timelines and drives process optimization initiatives that enhance operational efficiency, reproducibility, and overall product integrity.

Jean-Marie Schwab

Jean-Marie (Jeannie) Schwab is a Quality Systems Manager at Microbiologics, responsible for the oversight and continuous improvement of quality systems that support the development and release of viral materials. Her work includes governance of controlled documentation, quality process alignment, and support of validated inactivation methodologies to ensure materials are produced consistently and in accordance with established quality and regulatory expectations. Jeannie works cross-functionally to reinforce data integrity, process control, and compliance, helping ensure Microbiologics delivers dependable, fit-for-purpose viral materials.