COLUMBUS, Ohio, May 23, 2024
/PRNewswire/ -- Andelyn Biosciences, Inc., a leading and
patient-focused cell and gene therapy Contract Development and
Manufacturing Organization (CDMO), has been selected to manufacture
adeno-associated vectors (AAV) therapies using its suspension AAV
Curator™ Platform under the California Institute for
Regenerative Medicine (CIRM) Accelerating Medicines Partnership
(AMP) Bespoke Gene Therapy Consortium (BGTC).
Andelyn Biosciences to manufacture gene
therapies using its suspension AAV Curator(TM) Platform for
CIRM
The CIRM partnership with Andelyn was established to advance
BGTC's mission to develop platforms and standards to propel the
development and delivery of customized or 'bespoke' gene therapies
for millions of people affected with rare diseases. BGTC is
focusing on development of cures for eight such diseases, with
Andelyn selected to optimize and scale the AAV therapy processes
for the treatment of Congenital Hereditary Endothelial Dystrophy –
Type 1.
Matt Niloff, Chief Commercial
Officer of Andelyn, said: "As a long-standing pioneer in AAV gene
therapies and historical connection to the clinic, we have great
synergies with the CIRM/BGTC. Andelyn is privileged to work with
the CIRM/BGTC on its first AMP established specifically for rare
disease and leverage our AAV Curator™ Platform to help
overcome the major obstacles related to developing gene
therapies."
Dr. Abla Creasey, PhD, Vice
President of Therapeutics Development at CIRM said: "This
partnership with Andelyn will enable progress in the field and help
overcome manufacturing obstacles that can potentially lead to
breakthroughs for rare diseases like Congenital Hereditary
Endothelial Dystrophy."
With exceptional quality and scalable end-to-end development and
manufacturing capabilities across its three Columbus, Ohio facilities, Andelyn is enabling
the progression of life-altering gene therapies for rare and
prevalent diseases.
About Andelyn Biosciences, Inc.
Andelyn Biosciences is
a full-service cell and gene therapy CDMO focused on the
development, characterization and production of viral vectors for
gene therapy. With more than 20 years of experience, Andelyn's deep
scientific expertise has resulted in the production of cGMP
material for more than 450 clinical batches and 75 global clinical
trials. Operating out of three Columbus,
Ohio facilities, Andelyn supports its clients in developing
cell and gene therapies from concept through plasmid engineering
and manufacturing, process and analytical development, and cGMP
clinical and commercial manufacturing. Andelyn can accelerate
programs and deliver high quality products by developing and
manufacturing processes on its configurable, data-driven AAV
Curator™ Platform, or tech transfer in an established client
program. Capabilities include cGMP manufacturing for both adherent
and suspension processes up to a 2,000-liter capacity. A rigorous
quality system, regulatory support and supply chain vertical
integration further support clients in bringing their critical
therapies to market. For more information, visit
andelynbio.com.
About the California Institute for Regenerative Medicine
(CIRM)
At CIRM, we never forget that we were created by the
people of California to accelerate
stem cell treatments to patients with unmet medical needs, and act
with a sense of urgency to succeed in that mission. To meet this
challenge, our team of highly trained and experienced professionals
actively partners with both academia and industry in a hands-on,
entrepreneurial environment to fast track the development of
today's most promising stem cell technologies. With $5.5 billion in funding and more than 150 active
stem cell programs in our portfolio, CIRM is one of the world's
largest institutions dedicated to helping people by bringing the
future of cellular medicine closer to reality. For more information
go to www.cirm.ca.gov
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SOURCE Andelyn Biosciences