Charles River to Perform Plasmid Production for Ship of Theseus
04 Abril 2024 - 9:00AM
Business Wire
GMP grade plasmid DNA to serve as a direct
therapeutic targeting various indications
Charles River Laboratories International, Inc. (NYSE: CRL) and
Ship of Theseus, a therapeutics company developing
degradation-resistant homeobox (HOX) family biologics, today
announced a Good Manufacturing Practice- (GMP) plasmid DNA contract
development and manufacturing organization (CDMO) agreement. Ship
of Theseus will leverage Charles River’s premier expertise to
manufacture GMP plasmid DNA to serve as the active drug substance
for its lead candidate.
Ship of Theseus is developing a proprietary suite of biologics
based on the HOX family of transcription factors, which are
responsible for driving the differentiation of tissue stem cells
towards their respective lineages to repair and maintain the
correct function of tissues and organs. Proprietary modifications
may enable these regulators to be used as therapeutics.
The collaboration between Charles River and Ship of Theseus will
support therapeutic development for a broad variety of target
indications such as diabetic and chronic wounds, neutropenia,
psoriasis, androgenetic alopecia, women’s health and infertility,
and epithelial cancers. Charles River’s GMP plasmid DNA CDMO center
of excellence based in Keele, United Kingdom will lead the
collaboration, providing services that include plasmid DNA backbone
generation, plasmid synthesis, GMP master cell bank (MCB)
generation, pre-production evaluation, and GMP plasmid DNA
manufacture including in-house release testing.
Plasmid DNA Manufacturing Services In recent years,
Charles River has significantly broadened its cell and gene therapy
portfolio with several acquisition integrations and expansions 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.
With plasmid product and service offerings spanning
off-the-shelf and custom production of research, High Quality (HQ)
and GMP grade DNA, the Company leverages its eXpDNA™ plasmid
manufacturing platform built on established processes and
fine-tuned over decades successfully supporting vaccine and
advanced therapy clients through clinical trials and beyond.
Available on-demand is a 30-minute case study webinar led by Dr.
Andrew Frazer, Associate Director, Scientific Solutions, Gene
Therapy CDMO Services, that explores the role of plasmid DNA as a
critical starting material, the latest advancements in associated
regulatory guidance to safeguard your therapeutic programs, and
case studies demonstrating expedited development and manufacture of
ATMPs: https://bit.ly/3Vl5rgu
Approved Quotes
- “We are thrilled to work with Ship of Theseus to produce GMP
plasmid DNA to help advance the organization’s mission to develop
HOX family biologics. Charles River’s robust plasmid DNA
manufacturing portfolio and track record makes us the ideal
candidate to produce this critical material which has the potential
to impact numerous patient indications.” – Kerstin Dolph, Corporate
Senior Vice President, Global Manufacturing, Charles River
- “Ship of Theseus is proud to collaborate with Charles River as
our manufacturing partner of choice. We trust the team’s decades of
success developing, producing, and reliably delivering plasmid DNA
and look forward to bringing our therapies to patients.” – Jeremy
Elser, Founding CEO, Ship of Theseus
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.
About Ship of Theseus Ship of Theseus develops
therapeutics across diverse indications by leveraging the homeobox
(HOX) family of transcription factors. Utilizing the broad and
powerful cell regulatory capabilities of the HOX family, Ship of
Theseus and its indication-specific subsidiaries are targeting an
array of indications, with early emphasis on topicals for chronic
wounds. Proprietary modifications improve intracellular dynamics
and half-life, overcoming prohibitive shortcomings in the
endogenous sequences.
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version on businesswire.com: https://www.businesswire.com/news/home/20240404780001/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
Ship of Theseus Investor Contact: Jeremy Elser,
PhD Chief Executive Officer jeremy@ship-of-theseus.com
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