Charles River Unveils Lentivation Platform to Expedite LVV-based Gene Therapy Manufacturing
26 Setembro 2023 - 9:00AM
Business Wire
The platform can reduce lentiviral vector
production timelines from 18 months to less than 7 months
Charles River Laboratories International, Inc. (NYSE: CRL) today
announced the launch of its lentiviral vector (LVV) manufacturing
platform, Lentivation™. The platform has the capability to reduce
LVV manufacturing timelines for gene and gene-modified cell
therapies by up to 60 percent, translating to fewer than seven
months compared to traditional manufacturing workflows.
Charles River provides viral vector production services ranging
from clone construction through good manufacturing practice (GMP)
for clinical trials or commercial use and offers a dedicated
portfolio to meet customer specific needs such as regulatory
requirements or product characteristics, with stringent, in-house
quality control adhering to the highest standards of purity and
potency.
Meeting growing client needs for clinical and commercial supply,
Lentivation leverages Charles River’s robust screening toolbox for
tackling challenging gene-of-interest plasmids, off-the-shelf (OTS)
LVV packaging plasmids, phase-appropriate production with
fit-for-purpose facilities, on-hand materials, and in-house
analytics.
Gene Therapy CDMO Services With over 20 years of viral
vector contract development and manufacturing organization (CDMO)
expertise and validated platform processes with a proven track
record, Charles River has standardized protocols for cell culture,
transfection, and downstream purification. These high-yield,
optimized methods increase speed to clinical manufacturing by
reducing process development time and costs while ensuring high
quality production.
The addition of Lentivation follows the launch of Charles
River’s OTS LVV packaging and AAV pHelper plasmids, and eXpDNA™
plasmid manufacturing platform, aimed at supporting both LVV-based
and AAV-based gene therapy programs. Lentivation also complements
the nAAVigation™ platform announced previously, further bolstering
Charles River’s cell and gene therapy manufacturing
capabilities.
These offerings have been established over decades of plasmid
DNA and viral vector CDMO scale-up experience which, combined with
the Company’s in-house testing capabilities, significantly reduces
production turnaround time for advanced therapy medicinal product
(ATMP) and vaccine developers.
The Lentivation platform will be presented during the
BioInsight’s Expert Roundtable: Exploring current and future trends
in lentiviral vector manufacturing featuring Ramin Baghirzade, PhD,
Senior Director, Global Head Commercial, Gene Therapy CDMO Services
on September 27, 2023, at 11:00 am EDT.
Approved Quotes
- “We are thrilled to add the Lentivation platform to our robust
portfolio of existing capabilities. Our LVV manufacturing offerings
allow us to further support advanced therapy programs and, most
importantly, deliver novel gene therapies to patients across the
globe." - Kerstin Dolph, Corporate Senior Vice President, Biologics
Solutions, Charles River
- “Charles River’s LVV platform provides a streamlined, reliable
path for therapeutic developers to clinic and commercial. The
proven platform builds on Charles River’s established capabilities
and processes, fine-tuned over decades spent successfully
supporting advanced therapy clients.” - Beth Tebeau, Site Director,
Rockville, MD, Charles River
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/20230926556363/en/
Investor Contact: Todd Spencer Corporate Vice President,
Investor Relations 781.222.6455 todd.spencer@crl.com
Media Contact: Amy Cianciaruso Corporate Vice President,
Chief Communications Officer 781.222.6168
amy.cianciaruso@crl.com
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