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Charles River (CRL) Forges Collaboration With Ship of Theseus
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Charles River Laboratories International, Inc. (CRL - Free Report) recently announced a Good Manufacturing Practice (“GMP”) plasmid DNA contract development and manufacturing organization (“CDMO”) agreement with Ship of Theseus, a therapeutics company developing degradation-resistant homeobox (HOX) family biologics. Under the collaboration, the latter will leverage Charles River’s premier expertise to manufacture GMP plasmid DNA to serve as the active drug substance for its lead candidate.
The latest development is also expected to significantly boost the company’s Manufacturing Solutions segment.
Significance of the Collaboration
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 toward 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 partnership between Charles River and Ship of Theseus aims to 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. The company’s GMP plasmid DNA CDMO center of excellence based in Keele, United Kingdom, will lead the collaboration by providing services, such as plasmid DNA backbone generation, plasmid synthesis, GMP master cell bank generation, pre-production evaluation and GMP plasmid DNA manufacture, including in-house release testing.
More on the News
Charles River’s Global Manufacturing spokesperson expressed delight about working with Ship of Theseus to help advance the organization’s mission to develop HOX family biologics. The company has significantly broadened its cell and gene therapy portfolio in recent years, with several acquisition integrations and expansions to simplify complex supply chains and meet the growing demand for plasmid DNA, viral vector and cell therapy services.
With a robust plasmid DNA manufacturing portfolio and track record, Charles River is well-positioned to produce this critical material, which can potentially impact numerous patient indications. Combined with its legacy testing capabilities, the company offers an industry-leading “concept to cure” advanced therapies solution to help developers navigate the path to clinic and beyond.
With its plasmid product and service offerings spanning off-the-shelf and custom production of research, High Quality (HQ) and GMP grade DNA, Charles River leverages its eXpDNA plasmid manufacturing platform. eXpDNA was built on established processes and fine-tuned over decades by successfully supporting vaccine and advanced therapy clients through clinical trials and beyond.
Industry Prospects
Per a Research report, the global plasmid DNA manufacturing market was valued at $1.80 billion in 2023 and is expected to witness a CAGR of 21% by 2030.
Plasmid DNA forms the foundation for gene therapies and vaccines for several infectious, genetic and acquired diseases, enteric pathogens and influenza. The growing acceptance of cell and gene therapy products to treat various diseases globally and the availability of approved gene therapy products are boosting industry growth. Further, companies and research institutions are accelerating their R&D efforts to develop advanced therapies that target the cause of the disease at the genomic level, leading to heightened demand for plasmid DNA.
Other Developments in the Manufacturing Segment
Last month, Charles River announced an extension of the gene therapy manufacturing alliance with the National University of Singapore’s Yong Loo Lin School of Medicine. The collaboration will leverage Charles River’s market-leading CDMO expertise in HQ and GMP-compliant plasmid DNA, which serves as a critical starting material for its engineered stem cell cancer therapy and builds on a historic provision of research-grade plasmid.
The company also announced a comprehensive gene therapy manufacturing collaboration with Navega Therapeutics. As part of Charles River’s Cell and Gene Therapy Accelerator Program, Navega will have access to established CDMO capabilities and advisory services to produce an adeno-associated virus (AAV)-based gene therapy, NT-Z001, for Phase I clinical trials.
Updates From Peers
In the broader cell and gene therapy market, Charles River competes with prominent medtech players who are also making notable progress in their respective fields.
Thermo Fisher Scientific (TMO - Free Report) recently introduced the TSX Universal Series ultra-low temperature freezers, with enhancements to performance, user experience and energy efficiency. Featuring the Universal V-Drive technology, tighter control, faster recovery times, universal voltage and an expanded setpoint range, the TSX Universal Series seamlessly adapts to diverse workflows — from high-use academic labs to longer-term storage facilities.
Thermo Fisher also introduced the LInspector Edge In-line Mass Profilometer, which has set a new benchmark for electrode coating analysis. It also provides a foundation for higher-performance batteries, reduced risk to quality, better process control and more profitable operation.
Catalent, Inc. (CTLT - Free Report) recently entered into an all-cash merger agreement with Novo Holdings for an enterprise value of $16.5 billion. The strategic move allows the company to leverage Novo Holdings’ significant resources to accelerate investment in its business and enhance key offerings to continue offering premium development and manufacturing solutions for pharma and biotech customers.
Catalent also upgraded its capsule filling of Dry Powders for Inhalation and capsule blistering suites in the Boston facility to handle potent drugs. The company has now emerged as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.
The Swiss–American biotechnology company, CRISPR Therapeutics (CRSP - Free Report) , recently achieved significant regulatory milestones for its CRISPR/Cas9 gene-edited cell therapy, CASGEVY (exagamglogene autotemcel). Following the grant of conditional marketing authorization by the European Commission, CASGEVY is now the only genetic therapy approved in the European Union for treating severe sickle cell disease or transfusion-dependent beta thalassemia (TDT) in patients aged 12 years and older. The news comes less than a month after CRISPR Therapeutics secured the FDA’s approval for CASGEVY for the treatment of TDT, reflecting the power of the CRISPR platform to bring a potentially curative treatment option for this devastating disease.
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Charles River (CRL) Forges Collaboration With Ship of Theseus
Charles River Laboratories International, Inc. (CRL - Free Report) recently announced a Good Manufacturing Practice (“GMP”) plasmid DNA contract development and manufacturing organization (“CDMO”) agreement with Ship of Theseus, a therapeutics company developing degradation-resistant homeobox (HOX) family biologics. Under the collaboration, the latter will leverage Charles River’s premier expertise to manufacture GMP plasmid DNA to serve as the active drug substance for its lead candidate.
The latest development is also expected to significantly boost the company’s Manufacturing Solutions segment.
Significance of the Collaboration
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 toward 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 partnership between Charles River and Ship of Theseus aims to 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. The company’s GMP plasmid DNA CDMO center of excellence based in Keele, United Kingdom, will lead the collaboration by providing services, such as plasmid DNA backbone generation, plasmid synthesis, GMP master cell bank generation, pre-production evaluation and GMP plasmid DNA manufacture, including in-house release testing.
More on the News
Charles River’s Global Manufacturing spokesperson expressed delight about working with Ship of Theseus to help advance the organization’s mission to develop HOX family biologics. The company has significantly broadened its cell and gene therapy portfolio in recent years, with several acquisition integrations and expansions to simplify complex supply chains and meet the growing demand for plasmid DNA, viral vector and cell therapy services.
With a robust plasmid DNA manufacturing portfolio and track record, Charles River is well-positioned to produce this critical material, which can potentially impact numerous patient indications. Combined with its legacy testing capabilities, the company offers an industry-leading “concept to cure” advanced therapies solution to help developers navigate the path to clinic and beyond.
With its plasmid product and service offerings spanning off-the-shelf and custom production of research, High Quality (HQ) and GMP grade DNA, Charles River leverages its eXpDNA plasmid manufacturing platform. eXpDNA was built on established processes and fine-tuned over decades by successfully supporting vaccine and advanced therapy clients through clinical trials and beyond.
Industry Prospects
Per a Research report, the global plasmid DNA manufacturing market was valued at $1.80 billion in 2023 and is expected to witness a CAGR of 21% by 2030.
Plasmid DNA forms the foundation for gene therapies and vaccines for several infectious, genetic and acquired diseases, enteric pathogens and influenza. The growing acceptance of cell and gene therapy products to treat various diseases globally and the availability of approved gene therapy products are boosting industry growth. Further, companies and research institutions are accelerating their R&D efforts to develop advanced therapies that target the cause of the disease at the genomic level, leading to heightened demand for plasmid DNA.
Other Developments in the Manufacturing Segment
Last month, Charles River announced an extension of the gene therapy manufacturing alliance with the National University of Singapore’s Yong Loo Lin School of Medicine. The collaboration will leverage Charles River’s market-leading CDMO expertise in HQ and GMP-compliant plasmid DNA, which serves as a critical starting material for its engineered stem cell cancer therapy and builds on a historic provision of research-grade plasmid.
The company also announced a comprehensive gene therapy manufacturing collaboration with Navega Therapeutics. As part of Charles River’s Cell and Gene Therapy Accelerator Program, Navega will have access to established CDMO capabilities and advisory services to produce an adeno-associated virus (AAV)-based gene therapy, NT-Z001, for Phase I clinical trials.
Updates From Peers
In the broader cell and gene therapy market, Charles River competes with prominent medtech players who are also making notable progress in their respective fields.
Thermo Fisher Scientific (TMO - Free Report) recently introduced the TSX Universal Series ultra-low temperature freezers, with enhancements to performance, user experience and energy efficiency. Featuring the Universal V-Drive technology, tighter control, faster recovery times, universal voltage and an expanded setpoint range, the TSX Universal Series seamlessly adapts to diverse workflows — from high-use academic labs to longer-term storage facilities.
Thermo Fisher also introduced the LInspector Edge In-line Mass Profilometer, which has set a new benchmark for electrode coating analysis. It also provides a foundation for higher-performance batteries, reduced risk to quality, better process control and more profitable operation.
Catalent, Inc. (CTLT - Free Report) recently entered into an all-cash merger agreement with Novo Holdings for an enterprise value of $16.5 billion. The strategic move allows the company to leverage Novo Holdings’ significant resources to accelerate investment in its business and enhance key offerings to continue offering premium development and manufacturing solutions for pharma and biotech customers.
Catalent also upgraded its capsule filling of Dry Powders for Inhalation and capsule blistering suites in the Boston facility to handle potent drugs. The company has now emerged as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.
The Swiss–American biotechnology company, CRISPR Therapeutics (CRSP - Free Report) , recently achieved significant regulatory milestones for its CRISPR/Cas9 gene-edited cell therapy, CASGEVY (exagamglogene autotemcel). Following the grant of conditional marketing authorization by the European Commission, CASGEVY is now the only genetic therapy approved in the European Union for treating severe sickle cell disease or transfusion-dependent beta thalassemia (TDT) in patients aged 12 years and older. The news comes less than a month after CRISPR Therapeutics secured the FDA’s approval for CASGEVY for the treatment of TDT, reflecting the power of the CRISPR platform to bring a potentially curative treatment option for this devastating disease.