Predicting Viral Clearance: DOE, HTS, and AAV Case Studies Using a Non-Infectious MVM Surrogate in Downstream Development

Register free: https://www.biopharminternational.com/bp_w/predicting_viral_clearance​

Event Overview:

As viruses can arise during the manufacture of biopharmaceuticals, regulatory agencies require viral clearance validation studies for each biopharmaceutical prior to approval. These studies are typically conducted in biosafety level (BSL)-2 facilities and require large capital and human resources. Due to these hurdles, process knowledge pertaining to viral clearance is limited during development and characterization.

This webcast will explore the use of a BSL-1 compatible, non-infectious minute virus of mice (MVM) particle to predict viral clearance results over a wide variety of process development applications.

The use of an accurate, economical and quantifiable non-infectious viral surrogate enables downstream purification scientists to study viral clearance throughout process development.

In this webcast, learn about the results from several studies using an economical spiking surrogate, a non-infectious MVM-mock virus particle (MVM-MVP). Results from an anion exchange design-of-experiment study, ion exchange high-throughput screening, and downstream purification of an adeno-associated virus (AAV)-based viral vector will be presented.

Key Learning Objectives:

• Learn how viral clearance prediction is possible through the use of non-infectious surrogates (MVM-MVP) that mimic the physiochemical properties of live mammalian viruse
• Understand how MVM-MVP can be applied to downstream efforts such as design of experiments and high throughput screening and help facilitate process development/optimization.
• Review a study that demonstrated that AAVX resin was an effective viral clearance step within an AAV downstream purification process and comparative MVM vs. MVM-MVP data showed favorable prediction through the use of the non-infectious surrogate.

Speaker: David Cetlin, MS, Senior Director Research and Development, Cygnus Technologies, LLC.

Time and Date: Tuesday, Oct 6, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

On demand available after final airing until Oct. 6, 2021.

Sponsor:  Cygnus Technologies

Register free: https://www.biopharminternational.com/bp_w/predicting_viral_clearance​