Webinar Description:

This webinar will explore the use of a BSL-1 comptabile, non-infectious MVM particle to predict viral clearance results over a wide variety of process development applications.

Viruses can arise during the manufacture of biopharmaceuticals through contamination of exogenous viruses or endogenous expression of viral sequences. Regulatory agencies therefore require “viral clearance” validation studies for each biopharmaceutical prior to approval. These studies demonstrate the manufacturing processes ability to remove or inactivate virus and are conducted by spiking scaled-down process steps with live viruses. These studies are conducted in 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. The use of an accurate, economical and quantifiable non-infectious viral surrogate would enable downstream purification scientists to study viral clearance throughout process development.

A non-infectious Minute Virus of Mice – Mock Virus Particle (MVM-MVP) was generated by Cygnus Technologies for use as an economical spiking surrogate. In this webinar, we will discuss results from three studies. First, an AEX DOE study in which MVM-MVP clearance was compared to MVM and then used to generate a model for mapping design space. Second, a series of IEX high throughput screening experiments in which in-process vaccine material was spiked with MVM-MVP and processed through robo-columns under conditions of increased conductivity. Third, a comparative MVM vs. MVM-MVP clearance study utilizing AAVX resin (ThermoFisher) in a downstream AAV process. The results from these studies demonstrate the value of utilizing this non-infectious tool for process development and characterization.

Speakers:

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

David Cetlin is currently a Senior Director of R&D at Cygnus Technologies and was the founder and C.E.O. of MockV Solutions, Inc. - a company that pioneered and commercialized a novel series of BSL-1 compatible viral clearance prediction kits. These kits are designed to benefit downstream purification process scientists as they develop, characterize, and validate their downstream purification processes. In March 2020, MockV Solutions was acquired by Maravai LifeSciences the parent company of Cygnus Technologies, the worldwide leader in HCP assay kits.

Prior to MockV, David helped develop, characterize, and validate several monoclonal antibody purification processes at Human Genome Sciences and has worked with various separation techniques including all modes of column chromatography, tangential flow filtration, nano-filtration. During his time at HGS, David routinely designed and executed process related studies including resin lifetime studies, viral clearance studies, design of experiment (DOE) studies, etc. He also participated in the technology transfer of several processes to manufacturing scale cGMP facilities, provided on-site support during cGMP campaigns and conducted investigational studies to support deviations that occurred during such campaigns. He also explored and introduced new technologies and ideas to his purification team including a single pass mode of operating tangential flow filtration, a salt tolerant ion exchange membrane, and a pre-protein A depth filter for improving protein A lifetime.

Cost: No Cost!