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Detect Viral Contamination in your mAb process

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/DETECT M3192_180508_212 jpeg.jpgProduction 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.  

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This white paper examines the current in vivo methods for virus detection and explores alternative testing strategies which can be implemented today.

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Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: A Biosafety Revolution, the Medicine Maker

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-video-rp.svg Webinar Ending MAP/HAP: A stepping stone for accelerating cell line characterization
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-video-rp.svg Webinar: Rapid methodologies for Biosafety testing of biologic therapeutics
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg 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.

2. Rapidly confirm that adventitious agents are not present in cell banks
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.

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This webinar illustrates how rapid molecular technologies can be implemented to accelerate cell line characterization tests, but also how alternative methods may replace other cell line characterization tests, positively impacting timelines.

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Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-video-rp.svg Webinar: Current regulatory expectations and technical advances in the quality control of biological medicinal products
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Viral risk mitigation: A global regulatory perspective – Special report, BPI, 2018

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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.

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In this webinar you will learn:
  • Approaches to develop a risk mitigation program
  • Methods of characterizing biopharma raw materials
  • Variability in biopharma raw materials

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Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: Clearing viral concerns in animal-derived biomaterials

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: Assuring equivalency of alternative lot-release test methods

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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.  

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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.

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Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg 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

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals

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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.