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Viral Safety Assurance
 
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Prevent Adventitious Agent Contamination in Your mAb Process

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


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

Efficacy of Minute Virus of Mice (MVM) Inactivation Utilizing High Temperature Short Time (HTST) Pasteurization and Suitability Assessment of Pasteurized, Concentrated Glucose Feeds in Chinese Hamster Ovary (CHO) Cell Expression Systems

This study examines the efficacy of HTST pasteurization for inactivation of physiochemically resistant parvovirus using a bench-scale HTST system. Approximately six log10 inactivation of Minute Virus of Mice (MVM) was measured in concentrated glucose feeds and no impact was observed on the performance of the Chinese Hamster Ovary (CHO) expression system.


More Resources

Application note: High Temperature Short Time Pasteurization
Video: Pasteurization process
Webinar: HTST pasteurization of cell culture feeds for upstream viral safety


Product Information

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.

Featured Solution

Video Tech Talk: Using Nanofiltration to Prevent Virus Contamination of Cell Culture Processes

  • 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

Webinar: Defend your bioreactor: Barrier filtration as a key part of an upstream virus safety strategy
Webinar: Bioreactor Protection with the Viresolve® Barrier Filter
Poster: Implementation of a virus barrier media filter into fed-batch bioprocesses
Poster: Upstream virus safety: Protect your bioreactor by media filtration
Article: Upstream virus safety - Protect your Bioreactor with Media Filtration
Article: Advances in Upstream technologies Reduce Viral-Contamination
White Paper: Upstream Viral Safety - A Holistic Approach to Mitigating Contamination Risks


Product Information

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.

Featured Solution

Tech brief: CellPrime® rTrypsin Recombinant trypsin
Brochure: LONG®R3 IGF-I
 

More Resources

Webinar: Bioprocessing raw materials: Risk mitigation strategies


Product Information



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

Webinar: Genetic engineering of CHO cells for viral resistance to MVM

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

White Paper: MVM resistance through genetic engineering
Article: Protection at the genetic level – a new line of defense against contamination in biopharmaceutical manufacturing Sponsored supplement, Medicine Maker


Product Information

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

The Virus Risk Calculator tool is an algorithm to quantify the risk of virus contamination from animal-component free raw materials.

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