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Prevent Adventitious Agent Contamination in Your mAb Process


Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/bioreactor-man.jpg Bioreactors are at particular risk of contamination from adventitious agents. A contamination event can interrupt manufacturing schedules and require costly investigations resulting in lost revenue and potential disruptions in drug supply.

Traditionally, preventing upstream microorganism contamination has focused on sourcing and testing raw materials as well as filtration to remove bacteria and mycoplasma. High profile viral contamination events have led manufacturers to re-examine risk assessments around viral safety and consider implementing additional steps upstream of the bioreactor to reduce the risk of viral contamination. Such steps might include:
Quantify your risk of a potential virus contamination with the Risk Calculator


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Watch our video to know more about viral contamination prevention in upstream processes
1. Prevent viral contamination from cell culture media feeds with HTST treated glucose
Glucose is a critical component of many cell culture media and is generally regarded as a high-risk raw material for viral contamination. This high-risk designation arises from the plant origin source (sugarcane or beet fields) coupled with its innate attractiveness to virus-carrying rodents. HTST (High Temperature Short Time) pasteurization of glucose enables robust clearance of viruses with high physico-chemical resistance, and provides a point-of-origin solution to mitigate the risk of viral contamination in high-risk cell culture components.

Treatment of high-risk materials such as glucose with HTST brings peace of mind without compromising cell culture performance.

Featured Solution

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We have expanded our HTST pasteurization capabilities and can provide HTST-treated glucose, manufactured under an ISO9001:2015 comprehensive Quality Management System, to global markets. This application note describes how HTST pasteurization can provide viral contamination risk mitigation for large volume, high-risk raw materials such as glucose, without impacting feed viability or cell culture performance.
 

More Resources

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-video-rp.svg Video: Pasteurization process
 

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-video-rp.svg Webinar: HTST pasteurization of cell culture feeds for upstream viral safety
 
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Poster: Development of a High Temperature Short Time (HTST) viral load reduction model and process optimization for cell culture media treatment in an armfield pilot scale system


Product Information
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/HTST-Mid Scale-minimal-insulation-300px.png
High Temperature Short Time (HTST) treated glucose

HTST pasteurization is a highly effective method to inactivate viruses.




2. Prevent viral contamination from cell culture media using nanofiltration
Learn how the Viresolve® Barrier filter offers a familiar, easy-to-use technology, for efficient processing of cell culture media components to reduce the risk of bioreactor contamination.

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  • Removal of both enveloped and non-enveloped viruses in addition to bacteria and mycoplasma
  • Improved process economics compared to using downstream virus filters
  • Maintained cell culture performance
 

More Resources

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-video-rp.svg Webinar: Defend your bioreactor: Barrier filtration as a key part of an upstream virus safety strategy
 

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-video-rp.svg Webinar: Bioreactor Protection with the Viresolve® Barrier Filter
 

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Poster: Implementation of a virus barrier media filter into fed-batch bioprocesses
 
 
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Poster: Upstream virus safety: Protect your bioreactor by media filtration
 
 
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: Upstream virus safety - Protect your Bioreactor with Media Filtration
 
 
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: Advances in Upstream technologies Reduce Viral-Contamination
 
 
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg White Paper: Upstream Viral Safety - A Holistic Approach to Mitigating Contamination Risks


Product Information
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/viresolve-barrier.jpg
Viresolve® Barrier filters

Specifically designed to process cell culture media, Viresolve® Barrier filters are the last line of defense against bioreactor contamination.




3. Reduce viral contamination risks with non-animal origin and chemically-defined raw materials
Contamination often originates from raw materials and animal-derived components such as bovine serum or trypsin. Wherever possible, raw materials and animal-derived components at high risk of virus contamination should be replaced with low(er)-risk alternatives, such as chemically-defined cell culture media and non-animal origin recombinant supplements. 

 

More Resources

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Webinar: Bioprocessing raw materials: Risk mitigation strategies




4. Make your CHO cell line resistant to MVM infection
The risk of bioreactor contamination with an adventitious virus, such as Minute Virus of Mice (MVM), remains a challenge for all biopharmaceutical manufacturers. Fortunately, Chinese Hamster Ovary (CHO) cells that are resistant to MVM infection have been developed, offering a powerful tool to prevent bioreactor contamination. 

Featured Solution

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This webinar explains:
  • How genetic engineering technologies can be used to create viral resistance in CHO cells
  • How to include genetically engineered MVM resistance into a viral risk mitigation strategy
  • How to validate viral resistance in CHO cells
 

More Resources

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg White Paper: MVM resistance through genetic engineering
 
 
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: Protection at the genetic level – a new line of defense against contamination in biopharmaceutical manufacturing Sponsored supplement, Medicine Maker


Product Information
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/mvm-centinel.jpg
Centinel Intelligent Virus Defense™ technology

Centinel™ delivers true organizational value by reducing the risk of contamination, and in doing so, supports patient safety.


5. Tools: Understand your viral contamination risk
Understanding the risk of viral contamination from individual components in the upstream process can be challenging, and must be considered in the context of both the likelihood of a contamination, and the probability that contamination will be detected. Quantify your risk of a potential virus contamination with the Risk Calculator based on your specific process parameters. 


Viral Safety – Risk Calculator

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/tvs-calculator-thumbnail.jpgThe Virus Risk Calculator tool is an algorithm to quantify the risk of virus contamination from animal-component free raw materials.

Open Calculator