Vitrology
News
Beckman
Coulter Genomics and Vitrology Ltd. Partner to Offer
Comprehensive Biologics Testing Solutions
Alliance
Provides One-Stop Biosafety Testing Service
January
2011
DANVERS, Mass., and GLASGOW, UK – (January
17, 2011) — Beckman Coulter Genomics and Vitrology Ltd.
today announced a strategic partnership to offer customers
a wide range of biosafety testing services. The alliance provides
the biopharmaceutical industry with two inclusive sources
for the full complement of molecular, in vitro and in vivo
genomic services necessary for the identification, stabilization
and purification of biological products.
The alliance also provides customers with access to the next
generation sequencing technologies that are revolutionizing
biology. It is widely recognized that massively parallel sequencing
technologies hold incredible promise for the study of DNA
sequence variation in vaccines, cell banks and gene therapy
products, and allow the use of an open-question approach for
the safety characterization of biologics.
“Partnering with leading-edge innovators
to respond to the dynamic research needs of our customers
worldwide is fundamental to our goals as a quality genomic
services provider,” said Elena Jouravleva, global product
manager for Biologics Testing Services at Beckman Coulter
Genomics. “This alliance supplements Beckman Coulter’s
existing biologics testing services, which have a focus on
identity and stability testing, with Vitrology’s expertise
in biosafety testing, in both Good Manufacturing Practice
and Good Laboratory Practice environments.”
“We are pleased to partner with Beckman
Coulter Genomics to offer the global biotechnology industry
an array of scientific assays to fully characterize a wide
range of biologics,” said Margaret Temple, CEO of Vitrology.
“This dynamic new alliance is a natural fit, coupling
Beckman Coulter Genomics’ sequencing and marketing capabilities
with the experience of the Vitrology team to offer an expert
source of safety testing with sequencing data and analysis.
Both companies are committed to ensuring that they offer the
appropriate range of assays to ensure clients can achieve
regulatory authority approval for product safety.”
Beckman Coulter Genomics provides Sanger and
next generation DNA sequencing, gene expression profiling,
genotyping and biologics testing services. The collaboration
between Beckman Coulter Genomics and Vitrology further expands
and complements both companies’ extensive biologics
testing services portfolios, which are available to clients
worldwide.
About Beckman Coulter Genomics
Beckman Coulter Genomics, with headquarters
in Danvers, Massachusetts, is a leading global provider of
genomic services and nucleic acid purification products, serving
life-science researchers and the pharmaceutical industry throughout
the world. The company was created by combining Beckman Coulter’s
Agencourt Bioscience with Cogenics. By providing technical
expertise, combined with personalized service, Beckman Coulter
Genomics delivers the highest quality data, robust analyses
and innovative thinking. For more information, visit www.beckmangenomics.com
About
Beckman Coulter Inc.
Beckman Coulter, Inc., based in Orange County, California,
develops, manufactures and markets products that simplify,
automate and innovate complex biomedical tests. More than
a quarter of a million Beckman Coulter systems operate in
laboratories around the world, supplying critical information
for improving patient health and reducing the cost of care.
Recurring revenue, consisting of consumable supplies (including
reagent test kits), service and operating-type lease payments,
represent about 80 percent of the company's 2009 revenue of
$3.3 billion. For more information, visit www.beckmancoulter.com
or www.beckmancoulter.com/75years.
About Vitrology Limited
Vitrology Limited is a contract testing organization based
in Glasgow, Scotland, providing GMP and GLP assays to detect
potential contaminants in biological products, as well as
offering regulatory and consulting services. The company has
a highly experienced team, whose members have tested a wide
range of biopharmaceutical, vaccine and veterinary products,
from pre-clinical to commercial stage, over a fifteen-year
period. For more information, visit www.vitrologybiotech.com.
Beckman Coulter and the stylized logo are
registered trademarks of Beckman Coulter, Inc.
Detection of Porcine Circovirus Contamination of Biological
Samples by Real-time QPCR.
April
2010
A recent press releases from a major biopharmaceutical
company reported the presence of Porcine circovirus Type-1
(PCV-1) DNA in their product. The drug maker confirmed its
presence in both the cell bank and the virus seed from which
the vaccine is derived, suggesting its presence from the early
stages of vaccine development.
PCV is a single stranded DNA virus that is non-enveloped with
a non-segmented circular genome. The viral capsid is icosahedral
and approximately 17 nm in diameter. It is robust and difficult
to remove or inactivate by physico-chemical means, including
gamma irradiation.
Studies have shown that human cell lines can be infected with
porcine circovirus type 1 (PCV1) and porcine circovirus type
2 (PCV2). Infection of PCV1 was observed with HEK 293 and
Hela cells. PCV1 can persist in cell lines without causing
any visible changes, while PCV2-transfected cells can show
a cytopathogenic effect. PCV contamination could possibly
occur from the use of porcine trypsin in a cell lines history.
Since most cell lines have been exposed to this reagent, the
screening of all such cell substrates used for manufacture
of clinical material is recommended.
To assist biotech companies in ensuring the absence of PCV-1
and PCV-2, Vitrology’s team of QPCR experts offer a
highly sensitive, fully validated, cGMP compliant, routine
nucleic acid based test capable of sensitively detecting PCV-1,
PCV-2 and Bovine circovirus in biological samples.
French
Ministry of Research Approves Vitrology Limited as R&D
Subcontractor.
April
2010
Glasgow based Vitrology Limited has been successfully
approved as a subcontractor for research and development projects
by the French Ministry of Research. This approval enables
private companies subject to corporate tax in France to claim
R&D tax credits for work subcontracted to Vitrology Limited.
The approval process required the company
to present a recent development project that demonstrated
their competence as a subcontractor and as innovator.
Vitrology Limited has a number of French companies
amongst its client base and this agreement will support future
business growth.
Mr Philippe Grimm, Marketing Director of Vitrology
Limited commented: "We are pleased to have received this
approval which confirms the innovation energy of Vitrology
in the Bio Safety testing market and allows our clients based
in France to benefit from a tax incentive on any GMP/GLP studies
performed at Vitrology."
Vitrology Limited is a contract research organization
providing research and testing services to the animal health,
pharmaceutical and biotechnology industries for pre-clinical,
clinical and commercial biological drugs and vaccines.
For further information contact Philippe Grimm,
Marketing Director, Vitrology Limited
T: +33 479 61 21 92 – email: philippe.grimm@vitrologybiotech.com
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