MockV Solutions Announces the Publication of Data in BioProcess International and the Availability of a Recently Conducted Webinar

Rockville, MD – June 7th 2019 – MockV Solutions, Inc. (MockV or the Company), a
biotechnology company developing non-infectious viral clearance prediction products that
address the unmet needs of process development scientists as they establish biopharmaceutical
manufacturing platforms, announced today that a scientific manuscript detailing a proof of
concept study with collaborator GlaxoSmithKline and has been published in the journal
BioProcess International. In addition, MockV announces that a recently conducted “Ask the
Expert” webinar, hosted by BioProcess International, featured MockV data with collaborators
NIH-VRC and ThermoFisher Scientific.

The published study examined the use of MockV’s non-infectious Mock Virus Particles (MVP’s)
as a surrogate for Minute Virus of Mice (MVM) during Anion Exchange Chromatography. In-
process material was spiked with either MVP or MVM and challenged through columns packed
with Anion Exchange resin. The results demonstrated good clearance comparability over a range
of pH and Conductivity process parameters. In addition, a full factorial design of experiments
(DOE) was conducted with MVP alone. The clearance results were used to build a statistical
model from which process design space was mapped. “This data demonstrates the utility of this
economical MVP as an accurate surrogate to live MVM for process development and
characterization studies”, said MockV Founder and CEO David Cetlin. “MockV provides these
BSL-1 compatible particles as part of the MVM-MVP Kit, which is currently available. This
commercial kit is helping scientists design robust viral clearance into their biopharmaceutical
processes.”

A link to the article is provided here: https://bioprocessintl.com/downstream-processing/viral-clearance/modeling-virus-clearance-use-of-a-noninfectious-surrogate-of-mouse-minute-virus-as-a-tool-for-evaluating-an-anion-exchange-chromatography-method/

 

The “Ask the Expert” Webinar was conducted and recorded by BioProcess International on
April 24, 2019. The webinar highlighted data sets generated from two separate collaborations:
1) a high-throughput AEX study, conducted with the National Institute of Health’s Vaccine
Research Center; and 2) a Hydrophobic Interaction Chromatography study, conducted with
ThermoFisher Scientific. Each study demonstrated the ability of MockV’s MVM-MVP to serve
as an accurate and economical MVM surrogate for downstream process development studies.

A link to the Webinar is provided here: https://bioprocessintl.com/sponsored-content/clearing-the-way-for-viral-clearance/

About MockV Solutions Inc.

MockV Solutions, Inc. (MVS) is a biotechnology company commercializing non-infectious
viral-surrogate tools for a variety of industries that currently rely on expensive and logistically
challenging live virus analysis. MockV is developing a novel series of analytical assay kits
which will enable biopharmaceutical process development scientists to study the efficacy of
manufacturing techniques intended to remove or inactive virus, a contaminant of great concern
during the manufacturing of biopharmaceuticals. These products are only approved for clinical
or commercial use after their manufacturing processes demonstrate sufficient viral clearance.
Currently, this is accomplished through the use of live mammalian model viruses (ex. MVM and
XMuLV) in expensive and logistically challenging “spiking studies”. The lack of economical
and accurate means of analyzing viral clearance during small scale process development
increases the risk of failing viral clearance regulatory requirements – jeopardizing the timely
approval of potentially life-altering therapies. MockV’s lead product, the MVM-MVP Kit
contains a non-infectious “Mock Virus Particle” (MVP) that mimics the physicochemical
characteristics of live infectious MVM, as well as reagents and components to quantify MVP in
solution. For further information regarding MockV Solutions, Inc., please visit the Company’s
website at www.mockvsolutions.com.