Charles River Laboratories International, Inc. and Ship of Theseus 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 "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 therapeutic programs, and case studies demonstrating expedited development and manufacture of ATMPs.