Charles River and Vertex Pharmaceuticals Reach Important Milestone in Cell Therapy Manufacturing Collaboration
18 Dezembro 2023 - 10:00AM
Business Wire
Charles River’s Memphis facility approved to
manufacture Vertex’s CASGEVY™ therapy, the world’s first
gene-edited therapy targeting severe sickle cell disease
Charles River Laboratories International, Inc. (NYSE: CRL) today
announced an important milestone in their strategic collaboration
to manufacture CASGEVY™ (exagamglogene autotemcel
[exa-cel]). CASGEVY is approved in some countries for certain
eligible patients.
The news follows Charles River’s Memphis center of excellence
passing back-to-back audits from both the U.S. Food and Drug
Administration (FDA) and the Health Products Regulatory Authority
(HPRA), on behalf of the European Medicines Agency (EMA). The
Memphis facility was the first North American contract development
and manufacturing organization (CDMO) to be approved by the EMA to
commercially manufacture an allogeneic cell therapy drug
product.
“Our team in Memphis is proud to receive regulatory approval to
manufacture CASGEVY,” said James C. Foster, Chairman, President and
Chief Executive Officer, Charles River. “We are pleased to reach
this milestone working hand-in-hand with Vertex to manufacture the
world’s first gene-edited therapy. There is a tremendous patient
need for this therapy and we look forward to working with Vertex to
help bring this treatment to patients.”
Leveraging CRISPR to Treat SCD SCD is an inherited blood
disease impacting millions of people worldwide. SCD affects
hemoglobin, a part of the blood that carries oxygen around the
body. People who suffer from this condition require lifelong
treatment and significant use of health care resources, ultimately
resulting in reduced life expectancy. Vertex collaborated with
CRISPR Therapeutics to leverage the use of a gene-editing
technology, known as CRISPR/Cas9, to discover and develop
CASGEVY.
Cell Therapy Manufacturing Services Charles River
provides cell and gene-modified cell therapy developers with an
efficient, robust, and scalable process to swiftly transition
autologous and allogeneic programs to clinic and commercialization
with one production partner.
In recent years, the Company has significantly broadened its
cell and gene therapy portfolio with a substantial good
manufacturing practice (GMP)-compliant commercial-ready capacity
expansion and the integration of several strategic acquisitions to
simplify complex supply chains and meet growing demand for plasmid
DNA, viral vector, and cell therapy services. Combined with the
Company’s legacy testing capabilities, Charles River offers an
industry-leading “concept-to-cure” advanced therapies solution.
About Charles River Charles River provides essential
products and services to help pharmaceutical and biotechnology
companies, government agencies and leading academic institutions
around the globe accelerate their research and drug development
efforts. Our dedicated employees are focused on providing clients
with exactly what they need to improve and expedite the discovery,
early-stage development and safe manufacture of new therapies for
the patients who need them. To learn more about our unique
portfolio and breadth of services, visit www.criver.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20231218358306/en/
Charles River Investor Contact: Todd Spencer Corporate
Vice President, Investor Relations 781.222.6455
todd.spencer@crl.com
Charles River Media Contact: Amy Cianciaruso Corporate
Vice President, Chief Communications Officer 781.222.6168
amy.cianciaruso@crl.com
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