Uploaded July 2025 | Updated September 2026, 2 weeks ago
Viral clearance studies are part of a multifaceted approach to ensure the safety of biopharmaceutical products. In order to prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency on the removal or inactivation of adventitious agents early on during downstream process development.
A viral clearance study was performed to showcase the capabilities of a new weak anion exchange-hydrophobic interaction (AEX-HIC) mixed-mode resin, Nuvia wPrime 2A, with the introduction of co-spiked MuLV and MVM viruses. This occurred under three different pH conditions, and in all tested conditions, no residual infectivity was detected in the end products. These conditions assist in showing the promising capabilities of the Nuvia wPrime Media in viral clearance studies.
Practical considerations for developing a mAb purification process with mixed-mode chromatography with effective overall impurity clearance will also be discussed in this webcast.
Key Takeaways:
• Importance of early assessment.
• Effectiveness of Nuvia wPrime 2A media.
• Considerations for practical mAb purification.
#pharmaceutical #biopharma #chromatography
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00:00 - Speaker Intro
00:23 - Viral Clearance Intro
01:17 - Viral Clearance Study Design
02:50 - Pre-Tests Phase
04:44 - Single-Spiking Method
05:39 - Co-Spiking Method
06:20 - Mixed-Mode Chromatography
08:37 - Nuvia™ Mixed-Mode Media
10:03 - Nuvia w2Prime 2A Media Intro
11:19 - Nuvia w2Prime 2A Media Feasibility Runs
14:08 - Study Conditions
15:00 - Study Chromatograms
15:47 - Results
17:00 - Resources & Thank You
17:50 - Q&A
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Presenters:
• Janalyn Frederick, Supervisor, Process Evaluation, Charles River Laboratories
• Artur Stanczak, MSc, Field Application Specialist, Process Chromatography, Bio-Rad Laboratories
Janalyn Frederick is a viral clearance supervisor for Charles River Laboratories at their Wayne, PA location. Janalyn received her bachelor's degree in biology from DeSales University, Pennsylvania, in 2016. She started at Charles River Labs with the viral clearance department in 2016 as a technician and has been with the company for nine years. Her specialties are virus retentive filtration and virus propagation.
Artur Stanczak is a process chromatography application specialist at Bio-Rad Laboratories. He received his master's degree in biotechnology from the University of Maria Skłodowska-Curie in Lublin. Artur has more than 13 years of experience in the biotechnology and biopharma industry, specializing in downstream processing of therapeutics. He is experienced in process development, characterization, scale-up, and validation of biologics. Artur supports method development, downstream purification applications, and the Bio-Rad chromatography resins portfolio, as well as managing the process chromatography application laboratory located in Munich, Germany.
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Connect with Bio-Rad Online:
Visit Bio-Rad's Website: bio-rad.com
Follow Bio-Rad on LinkedIn: linkedin.com/company/bio-rad
Follow Bio-Rad on Facebook: facebook.com/biorad
Follow Bio-Rad on Instagram: instagram.com/bioradlabs
©2025 Bio-Rad is a trademark of Bio-Rad Laboratories, Inc. in certain jurisdictions. All trademarks used herein are the property of their respective owner.
Music used by permission granted by royalty-free license from Pond5.com
Viral clearance studies are part of a multifaceted approach to ensure the safety of biopharmaceutical products. In order to prevent costly changes to a manufacturing process, it is important to assess each operation unit for its efficiency on the removal or inactivation of adventitious agents early on during downstream process development.
A viral clearance study was performed to showcase the capabilities of a new weak anion exchange-hydrophobic interaction (AEX-HIC) mixed-mode resin, Nuvia wPrime 2A, with the introduction of co-spiked MuLV and MVM viruses. This occurred under three different pH conditions, and in all tested conditions, no residual infectivity was detected in the end products. These conditions assist in showing the promising capabilities of the Nuvia wPrime Media in viral clearance studies.
Practical considerations for developing a mAb purification process with mixed-mode chromatography with effective overall impurity clearance will also be discussed in this webcast.
Key Takeaways:
• Importance of early assessment.
• Effectiveness of Nuvia wPrime 2A media.
• Considerations for practical mAb purification.
#pharmaceutical #biopharma #chromatography
---
00:00 - Speaker Intro
00:23 - Viral Clearance Intro
01:17 - Viral Clearance Study Design
02:50 - Pre-Tests Phase
04:44 - Single-Spiking Method
05:39 - Co-Spiking Method
06:20 - Mixed-Mode Chromatography
08:37 - Nuvia™ Mixed-Mode Media
10:03 - Nuvia w2Prime 2A Media Intro
11:19 - Nuvia w2Prime 2A Media Feasibility Runs
14:08 - Study Conditions
15:00 - Study Chromatograms
15:47 - Results
17:00 - Resources & Thank You
17:50 - Q&A
---
Presenters:
• Janalyn Frederick, Supervisor, Process Evaluation, Charles River Laboratories
• Artur Stanczak, MSc, Field Application Specialist, Process Chromatography, Bio-Rad Laboratories
Janalyn Frederick is a viral clearance supervisor for Charles River Laboratories at their Wayne, PA location. Janalyn received her bachelor's degree in biology from DeSales University, Pennsylvania, in 2016. She started at Charles River Labs with the viral clearance department in 2016 as a technician and has been with the company for nine years. Her specialties are virus retentive filtration and virus propagation.
Artur Stanczak is a process chromatography application specialist at Bio-Rad Laboratories. He received his master's degree in biotechnology from the University of Maria Skłodowska-Curie in Lublin. Artur has more than 13 years of experience in the biotechnology and biopharma industry, specializing in downstream processing of therapeutics. He is experienced in process development, characterization, scale-up, and validation of biologics. Artur supports method development, downstream purification applications, and the Bio-Rad chromatography resins portfolio, as well as managing the process chromatography application laboratory located in Munich, Germany.
---
Connect with Bio-Rad Online:
Visit Bio-Rad's Website: bio-rad.com
Follow Bio-Rad on LinkedIn: linkedin.com/company/bio-rad
Follow Bio-Rad on Facebook: facebook.com/biorad
Follow Bio-Rad on Instagram: instagram.com/bioradlabs
©2025 Bio-Rad is a trademark of Bio-Rad Laboratories, Inc. in certain jurisdictions. All trademarks used herein are the property of their respective owner.
Music used by permission granted by royalty-free license from Pond5.com
