Charles River Launches Rep/Cap Plasmids to Streamline Adeno-Associated Viral Vector Manufacturing
16 Enero 2024 - 7:00AM
Business Wire
Off-the-shelf Rep/Cap simplifies gene therapy
supply chains with immediate availability
Charles River Laboratories International, Inc. (NYSE: CRL) today
announced the launch of its off-the-shelf Rep/Cap plasmid offering,
designed to streamline adeno-associated virus (AAV)-based gene
therapy programs.
Following the previously announced launch of its lentiviral
packaging and AAV Helper plasmid products, the addition of AAV
Rep/Cap (RC2, 5, 6, 8, 9) supplements a comprehensive range of
contract development and manufacturing organization (CDMO) products
and services, reducing manufacturing effort by up to 66%. The
ready-to-use plasmid products are produced and released according
to batch production records, with CMC guidance and a Certificate of
Analysis (COA) to support Investigational New Drug (IND) and
Clinical Trial Application (CTA) filing.
Using standard off-the-shelf plasmids, such as Helper and
Rep/Cap plasmid required for AAV production, gene therapy
developers leverage the advantages of being immediately available,
reducing development costs, risks, and timelines, subsequently
simplifying supply chains. Charles River’s Rep/Cap has been used
successfully to support the production of a range of AAV serotypes
carrying various therapeutic transgenes at multiple development and
GMP production scales.
Advanced Therapies Week Launch
Charles River will officially launch the off-the-shelf Rep/Cap
plasmid offering during Advanced Therapies Week, January 16-19, at
the Miami Beach Convention Center.
Ramin Baghirzade, PhD, Senior Director, Global Head Commercial,
Gene Therapy CDMO Services, will present: How to Expedite your Gene
Therapy Program: Platform Manufacturing Approaches. Join Dr.
Baghirzade in the Gene Therapy Manufacturing Track as part of the
Regulatory Alignment for Gene Therapy Manufacturing session to
learn how to:
- Ensure alignment with phase-appropriate plasmid DNA, AAV, and
lentiviral vector (LVV) manufacturing best practices
- Adopt an established platform approach for speed and
predictability
- Jump-start production with off-the-shelf products
Matthew Hewitt, B.A. PhD, Vice President, Technical Officer CGT
& Biologics, and a wealth of expert speakers will explore: The
Future of Cell and Gene Therapy Manufacturing, Development, and
Commercialization.
- Development of Cell and Gene Therapies: Preclinical CRO
perspective
- Delivering Next Generation CGT Manufacturing Solutions
- A Decentralized CDMO Manufacturing Strategy for Future
Readiness
- Market Access and Reimbursements
Plasmid DNA and Viral Vector CDMO Services
The addition of Rep/Cap plasmids completes a comprehensive range
of off-the-shelf plasmid products to support AAV and LVV production
and follows the launch of the eXpDNA™ plasmid, nAAVigation™ AAV,
and Lentivation™ lentiviral vector manufacturing platforms,
established over decades of plasmid DNA and viral vector CDMO track
records to expedite turnaround times.
Charles River has significantly broadened its cell and gene
therapy portfolio with several acquisitions and capacity expansions
to simplify complex supply chains and meet the growing global
demand for plasmid DNA, viral vector, and cell therapy services.
Combined with the Company’s legacy testing services, Charles River
offers an industry-leading “concept-to-cure” solution for advanced
therapies, helping developers to navigate the path to clinic and
beyond.
For more information, register for Charles River’s upcoming
BioInsights webinar on February 21, 2024, hosted by Andrew Frazer,
PhD, Associate Director, Scientific Solutions, Gene Therapy CDMO
Services, to explore Expediting Development and Manufacture of
Advanced Therapies: Critical Starting Materials Case Study:
https://bit.ly/3tPnakC
Approved Quotes
- “The launch of Charles River’s off-the-shelf Rep/Cap offering
is the latest in a series of portfolio enhancements designed to
streamline adeno-associated virus (AAV)-based gene therapy
programs. The reduction in production time and improved efficacy of
the supply chain will help accomplish our ultimate goal of
delivering safe, effective therapies to patients, faster.” –
Kerstin Dolph, Senior Vice President, Manufacturing, Charles
River
- “Gene therapy clients leveraging the Rep/Cap offering, combined
with Charles River’s established CDMO capabilities and
phase-appropriate approach, can expect reduced development costs,
risks, and timelines while ensuring the highest quality product.” -
Andrew Frazer, PhD, Associate Director, Scientific Solutions, Gene
Therapy CDMO Services, 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/20240116052099/en/
Investor: Todd Spencer Corporate Vice President, Investor
Relations 781.222.6455 todd.spencer@crl.com
Media: Amy Cianciaruso Corporate Vice President, Chief
Communications Officer 781.222.6168 amy.cianciaruso@crl.com
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