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Detect Viral Contamination in your mAb process

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Production processes should be free from detectable adventitious agents. Traditional tests for adventitious viruses offer opportunities for broad detection of diverse viruses however, these are time consuming tests and have limitations in terms of sensitivity and identification of specific contaminants. Molecular testing technologies such as Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) complement traditional cell-based methods, opening doors for more rapid, sensitive detection of viral contaminants.

Watch our video to learn more about viral detection

1. Accelerate biosafety testing of biological therapies

Traditional approaches to virus detection– cell-based and in vivo assays - have served the biopharma industry very well over the years, but they have a long turn-around and do not identify specific contaminants. New molecular methods such as broad specificity degenerate PCR, and next generation sequencing (NGS) have been developed not only to replace or supplement traditional test methods but also expand the detection capabilities, thus expediting viral safety testing.

The Blazar™ platform provides researchers with accurate and highly sensitive viral detection in just days. Combining the breadth of detection of NGS with the speed and sensitivity of PCR, Blazar™ platform relies on degenerate PCR primers for coverage of more than 5000 viral variants. By amplifying multiple targets within a conserved region of the viral family genome, Blazar™ platform detects a much broader range of adventitious viruses as compared to traditional PCR methods.

Featured Solution

White paper: Rapid Biosafety testing enables the future of manufacturing

This white paper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing that are more aligned with manufacturing trends.

More Resources

White paper: Alternatives to in vivo assays for biosafety testing of biologics
Article: A Biosafety Revolution, the Medicine Maker
Webinar Ending MAP/HAP: A stepping stone for accelerating cell line characterization
Webinar: Rapid methodologies for Biosafety testing of biologic therapeutics
Sponsored tutorial, GEN: Utility of Next-Generation Sequencing (NGS) for Biosafety Assessment of Biological Products

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Next Generation Sequencing

Our expertise in NGS-based biosafety testing services allows us to provide complete solutions to our clients, from sample preparation and library generation through sequencing and data mining using state of the art computational and bioinformatics platforms, tools and methodologies. These results provide our clients with peace of mind, so they know that their test material is safe for biopharmaceucal production.

Blazar™ Rapid Molecular Platform

The Blazar™ rapid molecular platform is a viable alternative to in vitro detection assays.

2. Cell line characterization using rapid methods

Extensive characterization of cell lines for biologics production is performed to confirm identity, stability and purity. There are many options for cell line analysis, and newer molecular methodologies offer opportunities for more rapid time to results.

Featured Solution

Avoid Surprises With Comprehensive Cell Line Characterization

Learn more about how cell line characterization is a key element of viral safety assurance and critical to preventing cell line contaminants from entering the manufacturing process.


More Resources

Webinar: Ending MAP/HAP: A stepping stone for accelerating cell line characterization
Webinar: Current regulatory expectations and technical advances in the quality control of biological medicinal products
Viral risk mitigation: A global regulatory perspective – Special report, BPI, 2018

Product Information

Cell line characterization

Cell Line Characterization is required by the regulatory bodies to confirm the species origin and history of the cell line; and characterize and test the identity, stability and purity.

3. Confirm that adventitious agents are not present in raw materials and bulks

Variability is inherently introduced by bioprocessing raw materials. A detailed initiative to fully characterize raw materials using orthogonal techniques can provide assurance that the raw materials are fit for purpose.

Featured Solution

Webinar: Setting up for Successful Lot Release Testing

In this presentation, we will cover the CMC testing requirements with a CHO production platform for global commercialization. We will explain testing of product intermediates and final product, product-specific qualification studies and highlight the application of new testing methods and their benefits to lot release testing.

More Resources

Webinar: Bioprocessing raw materials: Risk mitigation strategies
Article: Clearing viral concerns in animal-derived biomaterials
Article: Assuring equivalency of alternative lot-release test methods

Product Information

Raw Material Testing (

Our services are aimed at ensuring the quality and purity of raw materials used in the production of biologics.

Bulk lot release testing

We offer a comprehensive range of services and assays aimed at ensuring the quality and purity of unprocessed and purified bulk harvest materials used in the production of biologicals for the pharmaceutical and biotech industries.

4. Detect emerging viruses in raw materials

Viral contamination is a constant challenge to all biopharmaceutical production processes. Emerging viruses are of particular concern and need to be characterized to understand the potential threat to your process. Understanding the susceptibility of your raw materials to these viral contaminants, and the capability of classical assays to detect them, will affect your viral safety strategy.

Featured Solution

Webinar: Emerging Viral Risks and Mitigation Strategies in Biologics Manufacturing

Using Zika, Schmallenberg and Hepatitis E viruses as examples, watch our webinar to learn how to evaluate the risk of emerging viruses in raw materials and integrate appropriate testing into a holistic viral safety strategy.


More Resources

Article: Schmallenberg virus, an emerging viral pathogen of cattle and sheep and a potential contaminant of raw materials, is detectable by classical in-vitro adventitious virus assays
Article: Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals

Product Information

Adventitious Agents / Virology Testing

We perform in vitro assays designed to detect adventitious viruses in cell banks, virus seed stock, raw materials and final products.