LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) a
molecular diagnostics company that develops fully automated, rapid
pathogen detection systems, today announced it has successfully
utilized the MiQLab™ System to detect the presence of a slow
growing bacterium, responsible for millions of dollars of damages
to biopharmaceutical manufacturers.
Dr. Jack Regan, LexaGene’s CEO and Founder stated, “Last fall, a
global biopharmaceutical manufacturer contacted LexaGene and
purchased a MiQLab System as they wanted to improve their already
stringent quality assurance program centered around their
bioreactor work. This manufacturer continues to regularly use the
MiQLab System. As a result of discussions with this customer,
LexaGene is working to expand the number of targets included in its
bioreactor contamination panel and we expect our efforts supporting
this customer and the industry in general will drive additional
sales this summer.”
Dr. Regan added “The biopharmaceutical manufacturing sector is
rapidly growing and continues to ramp up to meet global demand for
vaccines, monoclonal antibodies, and therapeutic proteins. The
MiQLab System, using its fully automated sample preparation and PCR
technology, can screen a sample taken from a bioreactor for
multiple contaminants that could negatively affect a manufacturing
line. In comparison to standard lab-based testing methods, the
MiQLab System can return reliable results in a fraction of the
time.”
A brief interview with Dr. Regan may be viewed HERE.
Contamination within bioreactors is a common occurrence as it is
dependent on mammalian culture. It is critical to keep bioreactors
free of unwanted microorganisms. Vaccines made from culture must be
free of microorganisms for safety and contaminated batches must be
destroyed. Recently, Emergent Biosolutions had to discard 15
million doses of the Johnson & Johnson Covid-19 vaccine due to
quality issues when it was most needed in order to ensure a safe
vaccine supply.1,2 Microbial contamination has been responsible for
vaccine recalls and vaccine scarcity highlighting the need for
rigorous contamination testing during manufacturing process.3,4 One
of the more common contaminants in bioreactors is Cutibacterium
acnes (C. acnes), a commensal bacterium on human skin. The shedding
of dead skin cells from those maintaining bioreactors is a common
source of contamination with C. acnes.5,6 Not only is it common,
but it is also one of the hardest microorganisms to detect, because
it grows very slowly; taking a minimum of three days when starting
from ideal laboratory conditions and up to two weeks when starting
from a contaminated bioreactor sample.7 This very long growing time
has a massive negative impact on contract manufacturers
experiencing loss of very expensive products due to this
contamination.8
To minimize the impact of C. acnes on product stability and
conformity, rapid testing is needed during each of the four main
phases of manufacturing, including testing: the raw materials that
go into bioreactors, the seed cultures before transfer to a
bioreactor, the small bioreactor material being scaled up to a
larger bioreactor, and the final product prior to sending it to the
customer. Quickly identifying contamination during each of these
steps minimizes profit losses that are often assumed and built-in
to cost estimates for the manufacturer. Better testing also gives
the manufacturer more confidence in meeting their delivery
timelines for the customer.
Dr. Nathan Walsh, LexaGene’s Vice President of Applications
& Bioinformatics added, “We are pleased to announce that
LexaGene completed a study on C. acnes using the MiQLab System. In
this benchmark study, C. acnes was diluted in media down to
extremely low levels (below the limit of detection) and cultures
were grown for 24 hours to mimic growth in a bioreactor. Samples
were then collected for MiQLab processing and agar plating, where
the plates were incubated under ideal conditions and regularly
monitored for signs of countable colonies. Colonies on the plate
were not observable until three days after plating. In contrast,
the MiQLab successfully detected 100 percent of the samples in just
two hours.
Dr. Walsh concluded, “In real-world testing, the time benefit of
using the MiQLab System over culture may be greater than our
laboratory study as it generally takes two full weeks for primary
C. acnes cultures to grow from a bioreactor sample.6 Given the
MiQLab can detect this bacterium in just 2 hours, this represents a
168-times improvement in time-to-result. Such a drastic time
savings would potentially save manufacturers a significant amount
of money as they could more quickly identify contaminated
cultures.”
To learn more about LexaGene and the MiQLab System or subscribe
to company updates, visit www.lexagene.com, or follow us on Twitter
or LinkedIn.
On Behalf of the Board of DirectorsDr.
Jack ReganChief Executive Officer &
Chairman
For inquiries: 800.215.1824 | ir@lexagene.com or
info@lexagene.com
About LexaGene Holdings Inc.LexaGene is a
molecular diagnostics company that develops molecular diagnostic
systems for pathogen detection and genetic testing for other
molecular markers for on-site rapid testing in veterinary
diagnostics, food safety and for use in open-access markets such as
clinical research, agricultural testing and biodefense. End-users
simply need to collect a sample, load it onto the instrument with a
sample preparation cartridge, enter sample ID and press ‘go’. The
MiQLab™ system delivers excellent sensitivity, specificity, and
breadth of detection and can return results in approximately two
hours. The unique open-access feature is designed for custom
testing so that end-users can load their own real-time PCR assays
onto the instrument to target any genetic target of interest.
The TSX Venture Exchange Inc. has in no way
passed upon the merits of the proposed transaction and has neither
approved nor disapproved the contents of this press release.
Neither TSX Venture Exchange nor its Regulation Services Provider
(as that term is defined in the policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
This news release contains forward-looking information, which
involves known and unknown risks, uncertainties and other factors
that may cause actual events to differ materially from current
expectation. Important factors -- including the availability of
funds, the results of financing efforts, the success of technology
development efforts, the cost to procure critical parts,
performance of the instrument, market acceptance of the technology,
regulatory acceptance, and licensing issues -- that could cause
actual results to differ materially from the Company's expectations
as disclosed in the Company's documents filed from time to time on
SEDAR (see www.sedar.com). Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date of this press release. The company disclaims
any intention or obligation, except to the extent required by law,
to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
[1]
https://www.nbcnews.com/health/health-news/johnson-johnson-confirms-one-vaccine-batch-was-discarded-over-production-n1262696
[2]
https://www.jnj.com/johnson-johnson-statement-on-u-s-covid-19-vaccine-manufacturing
[3]
https://www.baltimoresun.com/news/bs-xpm-2004-11-18-0411180376-story.html
[4]
https://www.cdc.gov/vaccinesafety/concerns/history/hib-recall.html
[5] Lange-Asschenfeldt, B, D Marenbach, C Lang, A Patzelt, M
Ulrich, A Maltusch, D Terhorst, E Stockfleth, W Sterry, and J
Lademann. 2011. “Distribution of Bacteria in the Epidermal Layers
and Hair Follicles of the Human Skin.” Skin Pharmacology and
Physiology 24 (6): 305–11.
[6] Salaman-Byron, Angel L. 2020. “Probable Scenarios of Process
Contamination with Cutibacterium (Propionibacterium) Acnes in
Mammalian Cell Bioreactor.” PDA Journal of Pharmaceutical Science
and Technology 74 (5): 592–601.
[7] Piwowarek, Kamil, Edyta Lipińska, Elżbieta Hać-Szymańczuk,
Marek Kieliszek, and Iwona Ścibisz. 2018. “Propionibacterium
Spp.—Source of Propionic Acid, Vitamin B12, and Other Metabolites
Important for the Industry.” Applied Microbiology and Biotechnology
102 (2): 515–38.
[8] McDaniel, A. 2007. “Microbial Detection in Mammalian Cell
Culture Systems.” American Pharmaceutical Review 10 (2): 24.
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