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Viral Safety Assurance
 
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Remove Virus from the mAb Downstream Process

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Downstream purification operations help reduce the levels of infectious virus in the bulk material by either removing or inactivating virus. Downstream purification typically includes:

No matter which technology is used to reduce levels of virus, the clearance capabilities of downstream steps must be demonstrated as part of the process viral safety assessment.


Watch our video to learn more about virus removal


1. Leverage chromatography steps to help reach viral clearance targets

Most downstream processes include at least two chromatography operations and, although their primary objective is purification, efficient operation of these steps is critical to reaching viral clearance targets.

Featured Solution

Webinar: IEX chromatography: How to get the most out of Your mAb process

Ion exchange chromatography (IEX) following protein A capture comprises cation exchange chromatography (CEX) that reduces antibody aggregate levels and anion exchange chromatography(AEX) that removes residual host cell proteins and DNA. Both CEX and AEX can contribute to viral safety and process optimization of key factors influencing the separation of mAbs on IEX chromatographic columns will be presented during this webinar.



More Resources

Poster: Efficient virus clearance across the Merck downstream purification portfolio
Poster: Virus clearance using Eshmuno® HCX multi-mode cation exchange resin on minimally purified biopharmaceutical product feed
Article: Viral clearance in antibody purification using tentacle ion exchangers


Product Information

Affinity and ion exchange chromatography resins

Process-Scale Chromatography: Your key to a successful journey from process development to production scale.



2. Meet high quality standards for raw materials used for viral inactivation

Chemicals, used for virus inactivation, must meet the same high-quality standards as other raw materials in your process.

Your raw materials should be manufactured under GMP* to ensure reliable performance and should include comprehensive documentation to simplify regulatory filings.

*based in IPEC - PQG GMP guide for pharmaceutical excipients 2006

Featured Solution

All our high quality raw materials are either manufactured or purified under GMP in consistent high purity, thus making your process reliable. They bear the EMPROVE® trademark and come with comprehensive documentation to simplify your regulatory filings.



Product Information

Emprove® products for low pH and solvent/detergent treatments

High Quality Chemicals for Virus Inactivation



3. Productive, reliable virus filtration

Virus filtration is a dedicated viral clearance step in most biopharma processes and is a key step in meeting viral safety targets. Understanding the operating conditions for processing efficiency and reliable virus retention mitigates risk and provides peace of mind.

Featured Solution

Webinar: QBD for downstream virus filtration

QbD principles can be applied to understand the critical processing and feed parameters affecting virus retention, guiding the development of a streamlined validation approach and robust process control strategy for virus clearance unit operations.

 

More Resources

Webinar: Parvovirus-retentive filter performance and removal mechanisms during process interruptions
Article: Impact of process interruption on virus retention of small-virus filters
Webinar: Quality by Design (QbD) for virus filtration
Application Note: Virus Retention Performance of Viresolve® Pro Devices under a Range of Processing Conditions

Download Guidebook


Product Information
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/viresolve.jpg
Viresolve® Pro virus filtration solution

The Viresolve® Pro Solution provides a comprehensive, flexible template solution for viral clearance within mAb and recombinant protein bioproduction.


4. Improve virus filtration efficiency with prefiltration technologies

Selecting a virus filter that delivers the performance you expect, is easy. Achieving optimum performance that can be relied on for the life of the production process requires time and resources. Filtration efficiency can be dramatically improved by incorporating prefiltration technologies to increase throughput on the virus filter and assure long-term cost effectiveness for your process.

Featured Solution

Webinar: Viral clearance with Viresolve® Pro Solution: Prefiltration strategies for optimizing performance

Although process intermediates are highly purified prior to viral clearance filtration, the presence of protein aggregates, denatured proteins and other trace fouling species can negatively impact the hydraulic performance of virus filters, increasing the required filtration area. Implementing a robust prefiltration step will clear these fouling species, leading to significant improvements in virus filter capacity, flux and an overall decrease in viral filtration costs.



More Resources

Webinar: Optimizing viral clearance filtration: Enhancing performance with the use of adsorptive depth or surface modified prefilters
Article: Virus filtration process development optimization
Poster: Prefiltration and process improvements: Enhancing virus filter performance with the use of adsorptive depth or surface modified prefilters


Product Information

Viresolve® Pro virus filtration solution

The Viresolve® Pro Solution provides a comprehensive, flexible template solution for viral clearance within mAb and recombinant protein bioproduction.



5. Predicting virus filter area requirements for production scale processes

Sizing filters to predict the virus filter area requirements for larger production scale processes, is a critical step in process development. This short video describes how to perform small-scale studies with the Vmax™ method to predict filter area requirements for larger, production-scale processes.

Featured Solution

Tech Tutorial Vmax™ Constant Pressure Test for Sizing Viral Clearance Filters (video)

This video describes how to perform small scale virus filtration studies with Vmax™ filter sizing method, to assess the performance of any feed solution on a virus filter, and how to use the results of the small-scale study to predict the virus filter area requirements for larger, production scale processes. The Vmax™ filter sizing method is appropriate for sizing filters run under constant pressure such as Viresolve® Pro filters for virus removal in downstream processes.


More Resources

Tech Tutorial Vmax™ Constant Pressure Test for Sizing Viral Clearance Filters


Product Information
Vmax™ Test Kit Viresolve® Pro
micro devices		 Viresolve® Pro Shield Viresolve® Pro Shield H


6. Demonstrate the effectiveness of the viral clearance steps

Manufacturers of biologics are required to evaluate their downstream manufacturing process for the ability of selected unit operations to inactivate or remove potential contaminants. The results of such clearance studies are required by regulatory authorities for investigational new drug (IND) submissions. Understanding regulatory expectations is a key component of clearance study design and informs your entire viral safety strategy.

Featured Solution

Webinar: Getting it Right. A Candid Conversation About Remote Viral Clearance Studies

Discover how we partner with you early on study design and discuss study preparation considerations, potential challenges, and how we deliver best-in-class Provise™ clearance services without the need to ever travel.

 

More Resources

Webinar: Parvovirus Retentive Filter Spiking Study Best Practices
Article: Fundamentals of viral clearance studies part 1: Selection of a viral panel and an appropriate virus spike
Article: Fundamentals of viral clearance studies part 2: How to design pre-study experiments for viral clearance studies
Article: Fundamentals of viral clearance studies part 3: Study design factors for optimal log reduction
Article: Fundamentals of viral clearance studies part 4: Considerations for evaluating viral clearance by chromatography steps
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: Fundamentals of viral clearance studies part 5: How much is enough?
Article: Filterability of virus stocks


Product Information

Provise™ Clearance Services (sigmaaldrich.com)

Our Provise™ Clearance Services can deploy a team of highly trained process scientists and study directors on your behalf, performing all your required process steps at our state-of-the-art facilities.



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