VIRAL SAFETY SOLUTIONS: PURIFIED VIRAL STOCKS AND ADVANCED NGS SERVICES

Prevent Contamination, Detect Threats, and Remove Risks with Precision

In the development and manufacturing of biologics, viral safety is paramount. Undetected viral contaminants can compromise product integrity, endanger patients, and result in regulatory setbacks. Viral safety testing ensures that biologic products, including biopharmaceuticals, cell and gene therapies, and vaccines, meet stringent safety and efficacy standards.

PRINCIPLES OF VIRAL SAFETY TESTING

Our approach is grounded in the principles of Prevent, Detect, and Remove to give you complete confidence in your biologics production.

Key Challenges

Each aspect of viral safety presents its own unique challenges. At Microbiologics, we deliver targeted solutions to navigate the complexities of viral safety testing. By leveraging advanced technologies, deep scientific expertise, and uncompromising quality standards, we empower you to safeguard your products, processes, and patients at every stage, including:

Assay Validation and Standardization: Ensuring your viral safety assays are optimized, reproducible, and meet the highest industry standards.

Contamination Monitoring and Resolution: Rapidly identifying and addressing contaminants to prevent costly disruptions.

Regulatory Compliance for Biologics and Vaccines: Providing guidance and tools to navigate complex regulatory requirements with confidence.

Training and Proficiency Testing: Enhancing your team’s expertise to maintain operational excellence and regulatory readiness.

OUR VIRAL SAFETY SOLUTIONS

Backed by over 50 years of expertise, Microbiologics provides customized viral safety solutions tailored to the specific demands of the bio/pharmaceutical industry. With state-of-the-art BSL-2 and BSL-3 laboratories and a collaborative, consultative approach, we deliver the confidence and reliability you need. Whether you're taking your first steps in viral safety or tackling complex challenges, our experts are ready to support you.

Purified Viral Stocks

Streamline your testing workflows with our ready-to-ship viral stocks. Designed for use with human and animal cell lines, these stocks are rigorously characterized for genome copy number, host copy number, and infectious titer to align with industry standards. Each stock is purified to ensure genome integrity and regulatory compliance, offering a reliable resource for your viral safety applications.

Custom Viral Stocks

Tailored to your specifications, our custom viral stocks are designed to address the unique demands of your research and manufacturing processes. Whether you need a specific strain or aim to replicate production conditions with your proprietary material, our experts deliver reliable, high-quality solutions. We offer full customization, allowing you to choose host cells, culture conditions, purification methods, titration parameters, and options for inactivation or attenuation to suit your exact requirements.

In Vitro Viral Safety Assays

In vitro viral safety assays provide rapid and reliable detection of adventitious agents to support biologics development and manufacturing. Traditional methods remain essential for regulatory compliance, and advanced technologies such as cell-based assays, PCR-based assays, immunological assays, and next-generation sequencing (NGS) all play important roles in building a comprehensive viral safety strategy.

Cell-Based Infectivity Assays

Detect replication-competent viruses using indicator cell lines that support broad-spectrum viral growth. Essential for screening cell substrates, raw materials, and manufacturing intermediates.

PCR-Based Detection Assays

Provide highly specific and sensitive detection of viral nucleic acids, identifying both active and inactive particles. Critical for targeted screening and viral clearance validation.

Immunological Assays (ELISA-based)

Enable detection of viral antigens and immune responses to contamination. Ideal for screening specific viral families, monitoring manufacturing environments, and validating inactivation processes.

Our Comprehensive Assay Capabilities

Microbiologics offers a full suite of specialized viral assays including TCID50, plaque assays, microneutralization, hemagglutination inhibition (HAI), neuraminidase inhibition (NAI), and IC50 testing. Our expert team develops custom assays for product release testing, including replication competent virus detection for viral vectors. We also provide avian influenza assay support for both low pathogenic (LPAI) and highly pathogenic (HPAI) strains, antiviral efficacy testing, and specialized applications like antiviral activity testing for textiles and plastics.

Learn more about our Assay Development Services

Next-Generation Sequencing (NGS) and Bioinformatics Services

The emerging standard for viral safety testing, delivering comprehensive insights into viral genomes, the composition of complex biological samples, and contamination events. This advanced technology excels in detecting genetic mutations, identifying pathogens, and supporting high-throughput analysis, making it ideal for bio/pharmaceutical viral safety testing and research. Our full end-to-end NGS offering enables comprehensive adventitious agent detection programs that surpass traditional methods in sensitivity and scope.

Learn more about our NGS and Bioinformatics Services

ELEVATE YOUR VIRAL SAFETY WITH MICROBIOLOGICS

Let Microbiologics be your trusted partner in viral safety. Our comprehensive solutions are designed to overcome your most pressing challenges, ensuring the integrity of your biologics and the safety of your patients. When you partner with Microbiologics you get access to:

Unmatched Expertise: 50+ years of experience in microbial and viral solutions.

Advanced Laboratories: State-of-the-art technologies designed to address the evolving challenges of viral safety.

Collaborative Approach: Partnering with you to develop customized solutions for your specific needs.

Commitment to Quality: A proven track record of delivering precise, reliable, and compliant products and services.