Charles River Collaborates with Pluristyx, Expanding its Portfolio of Human Pluripotent Stem Cells

Rhea-AI Summary

Charles River Laboratories International, Inc. (NYSE: CRL) has partnered with Pluristyx Inc. to expand its stem cell research tools, including high-quality embryonic stem cells and induced pluripotent stem cells. The collaboration aims to accelerate therapeutic development by providing researchers with advanced cell lines and technologies for new therapies.

Insights

Biotechnology Analyst

Charles River Laboratories' strategic agreement with Pluristyx Inc. represents a significant enhancement of its research toolkit, which is particularly relevant for the burgeoning field of regenerative medicine and cell therapy. By integrating high-quality embryonic stem (ES) cells and induced pluripotent stem cells (iPSCs) into their offerings, Charles River is positioning itself to meet the growing demand for reliable, well-characterized stem cell lines that are essential for drug discovery and therapeutic development.

From an industry perspective, the use of iPSCs is transformative due to their ability to differentiate into any cell type, offering a versatile platform for modeling diseases, testing drugs and potentially treating a wide array of conditions. Charles River's distribution of Pluristyx’s ES and iPSC lines, including those with the proprietary FailSafe® safety-switch technology, may reduce the risk profile associated with stem cell therapies and could be a pivotal step in addressing regulatory concerns regarding cell therapy safety.

The collaboration's emphasis on Good Tissue Practice-compliant stem cell lines also underscores a commitment to meeting stringent regulatory standards, which is critical as the industry moves closer to clinical applications. The potential reduction in timelines and downstream costs could have a positive impact on the speed at which new therapies reach the market, benefiting patients and possibly creating economic efficiencies for developers and investors alike.

Market Research Analyst

The strategic alliance between Charles River and Pluristyx Inc. is likely to have a ripple effect across the biotechnology and pharmaceutical sectors. By providing access to a broader range of high-quality stem cell lines, Charles River is not only expanding its own market reach but also empowering other companies and researchers in the field. This could lead to an acceleration in therapeutic development and a competitive edge for Charles River in the contract research organization (CRO) market.

Furthermore, the availability of NIH-registered ES cell lines for NIH-funded research could enhance Charles River's attractiveness as a partner for academic and government research institutions. This is significant because securing such partnerships can lead to long-term collaborative projects and potentially result in novel discoveries that could be commercialized.

As cell therapies continue to gain traction, the demand for specialized cell lines will likely increase, potentially driving growth for Charles River. The partnership with Pluristyx positions Charles River to capitalize on this trend and could positively influence its stock market performance as investors look for companies with a strong foothold in innovative and high-growth areas of the life sciences industry.

Regulatory Affairs Specialist

The collaboration between Charles River and Pluristyx Inc. touches on several regulatory considerations that are central to the development of cell therapies. The emphasis on full donor consent and compliance with Good Tissue Practice for specific pluripotent stem cell lines is indicative of an industry moving towards more ethically sourced and regulated biomaterials. This shift is not only ethically important but also strategically savvy, as it aligns with the increasing scrutiny from regulatory bodies like the FDA.

The proprietary FailSafe® safety-switch technology within Pluristyx’s iPSC panCELLa™ platform is particularly noteworthy. It potentially represents a significant advancement in the safety of cell therapies, which is a critical aspect of regulatory approval processes. By incorporating such technologies, Charles River may be facilitating a smoother regulatory pathway for its clients' cell-based therapies, ultimately expediting their time to market.

For stakeholders, the agreement suggests that Charles River is proactively addressing the complexities of cell therapy development, from ethical sourcing to regulatory compliance. This could reassure investors and partners of the company's commitment to quality and safety, potentially influencing its market valuation and stakeholder trust positively.

The addition of ES cells and iPSCs will enhance Charles River’s portfolio of powerful research tools supporting acceleration of therapeutic development.

WILMINGTON, Mass.--(BUSINESS WIRE)-- Charles River Laboratories International, Inc. (NYSE: CRL) today announced that it has entered into an agreement with Pluristyx Inc., a leading provider of tools, technologies, and services for the development of cell therapies. The collaboration provides Charles River with broad access to highly characterized and unique stem cell lines, including high-quality embryonic stem (ES) cells and induced pluripotent stem cells (iPSCs) as research tools to support development of new therapeutics.

Pluristyx offers a unique product and technology platform in the stem cell biology field for development of new therapies while reducing timelines and downstream costs. Through the agreement, Charles River will distribute Pluristyx’s wild-type and genetically engineered iPSCs as well as their comprehensive portfolio of normal and disease state ES cell lines. All of Pluristyx’s pluripotent cell lines are produced under full donor consent and the ES cell lines are registered and approved by the U.S. National Institutes of Health (NIH) making them eligible for use in NIH-funded research. Pluristyx’s iPSC panCELLa™ platform includes the proprietary FailSafe^® safety-switch technology enabling the development of safer, next-generation cell therapies.

Under the terms of the agreement, Charles River will distribute a broad catalog of Pluristyx’s ES and iPS cell lines for research use and will exclusively offer specific pluripotent stem cell lines derived under Good Tissue Practice to support a path to the clinic. The addition of Pluristyx’s offerings complements Charles River’s expansive portfolio of high-quality human cellular materials.

Shaping the Future of Drug and Therapeutic Development

ES and iPS cells provide a valuable tool for researchers to gain access to various types of specialized and differentiated cells that are otherwise inaccessible to study disease onset and progression and to develop a multitude of effective therapies. With its expanded portfolio of ES and iPS cell lines, Charles River enhances its position as a global leader in supplying critical human-derived biomaterials, including a wide range of immune cells and hematopoietic stem cells from both healthy donors and patients to drive advancements in stem cell biology, disease remodeling, toxicity studies, developmental biology, regenerative medicine, drug discovery, and cell therapy development.

Charles River is committed to leading the industry in identifying technologies and supporting efforts by global regulatory bodies to advance solutions that reduce the impact on in vivo research models through its 4Rs mission. The development of complex in vitro models using human-derived cells is one of many critical steps in revolutionizing therapeutic research and development. The alliance with Pluristyx provides Charles River clients access to research tools for advancing in vitro translational cell-based assays for drug discovery.

Approved Quotes

• “We are thrilled to integrate Pluristyx into our robust portfolio of human cell products and services. This alliance provides our clients with access to high quality research tools, adding considerable value and helping to develop safe and effective therapies to patients across the globe.” - Birgit Girshick, Executive Vice President and Chief Operating Officer, Charles River
• “We are honored to work with Charles River as a worldwide distributor of our pluripotent stem cells, including our genetically modified iPSCs that provide an accelerated path to the clinic with development of safer cell therapies. Through this agreement, we can continue our mission to rapidly advance development of next generation therapies.” - Benjamin Fryer, PhD, Chief Executive Officer, Pluristyx

About Pluristyx

Pluristyx, through its panCELLa™ platform, offers a portfolio of unique iPSC-based technologies, proprietary genetic engineering, and related tool-products and services to provide end-to-end client support throughout the products’ lifecycle. Pluristyx is fast becoming the leading provider of gene-edited iPSC and cell therapy solutions, accelerating customers’ path to clinic, and providing the best and fastest route to commercialization of cell-based therapeutic products. For more information on Pluristyx, visit www.pluristyx.com.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240220481133/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

Source: Charles River Laboratories International, Inc.

FAQ

What is the significance of the partnership between Charles River and Pluristyx Inc. (NYSE: CRL)?

The partnership aims to enhance Charles River's portfolio of research tools by providing access to high-quality ES cells and iPSCs for accelerating therapeutic development.

What unique products and technologies does Pluristyx Inc. offer in the stem cell biology field?

Pluristyx offers highly characterized and unique stem cell lines, including wild-type and genetically engineered iPSCs, as well as a comprehensive portfolio of normal and disease state ES cell lines.

What is the proprietary technology included in Pluristyx's iPSC panCELLa™ platform?

Pluristyx's iPSC panCELLa™ platform includes the FailSafe® safety-switch technology, enabling the development of safer next-generation cell therapies.

How does the agreement between Charles River and Pluristyx benefit researchers?

The agreement allows Charles River to distribute Pluristyx's ES and iPS cell lines for research use, supporting the development of new therapeutics and providing access to specialized cells for disease study and therapy development.

What areas of research and development will be supported by the expanded portfolio of ES and iPS cell lines?

The expanded portfolio will support advancements in stem cell biology, disease modeling, toxicity studies, regenerative medicine, drug discovery, and cell therapy development.