Charles River Enters Manufacturing Collaboration with Gazi University

Key Terms

cell and gene therapy medical

Therapies that use living cells or altered genes to treat or cure disease by repairing, replacing or reprogramming parts of the body; think of it as swapping or reprogramming malfunctioning hardware or software inside the body. Investors watch these treatments closely because they can command high prices and offer one-time or long-lasting benefits, but they also carry big development costs, complex manufacturing and regulatory risks that can cause large swings in a company’s value.

cdmo financial

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

aav medical

AAV is a small, generally harmless virus repurposed by researchers as a delivery vehicle to insert therapeutic genes into human cells; think of it as a postal service that carries corrective DNA to specific tissues. Investors pay attention because AAV-based treatments can offer durable, potentially one-time cures that command high prices, but they also carry development, manufacturing and regulatory risks that can sharply influence a biotech company’s value.

in vitro medical

In vitro describes laboratory tests performed on cells, tissues, or biological molecules outside a living body—literally “in glass,” such as in test tubes or dishes. For investors, in vitro results are an early sign that a drug or technology has a desired effect under controlled conditions, but they don’t guarantee it will work or be safe in animals or people; think of them as a prototype tested on a bench rather than in real-world use.

hyperphosphatemic tumoral calcinosis medical

A rare inherited condition where the body deposits hard, calcium-like lumps in soft tissues, often near joints or under the skin, because it cannot keep blood phosphate levels low enough. For investors, it matters because the condition creates a clear unmet medical need and a focused market opportunity for drugs or tests that control phosphate or dissolve deposits, but also brings clinical, regulatory and small-patient-population risks similar to other rare-disease programs.

galnt3 medical

GALNT3 is a human gene that makes an enzyme which attaches simple sugar tags to other proteins, a process that helps proteins fold, function and reach the right place in the body. Investors care because abnormalities in GALNT3 can drive certain diseases and serve as a target or biomarker for drugs and diagnostics, so changes in research, clinical results or approvals involving GALNT3-related activity can materially affect the commercial prospects of therapies and tests — like a factory label that determines whether products work or get shipped.

viral vectors medical

Viral vectors are tools that use viruses to deliver genetic material into cells, often to modify or influence how those cells function. They are important to investors because they are a key technology in gene therapy and biotechnology, industries that are rapidly growing and could lead to new medical treatments. Their effectiveness and safety influence the success and valuation of biotech companies developing these therapies.

Cell and Gene Therapy CDMO to bolster rare disease research at Gazi University Faculty of Medicine

WILMINGTON, Mass.--(BUSINESS WIRE)-- Charles River Laboratories International, Inc. (NYSE: CRL) and Gazi University Faculty of Medicine, today announced a gene therapy contract development and manufacturing organization (CDMO) collaboration, providing plasmid DNA for AAV production and in vitro efficacy studies.

“We are excited to build a strong collaboration with Gazi University,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River. “Leveraging cell and gene therapy CDMO expertise will enable the Faculty of Medicine to test and ultimately transform ground-breaking concepts into real-world therapies.”

Hyperphosphatemic tumoral calcinosis (HTC) is a rare inherited disorder causing high blood phosphate and painful, non-cancerous calcium phosphate deposits in soft tissues, especially around joints like hips, shoulders, and elbows, leading to pain, inflammation, and movement issues. It is caused by genetic defects in regulating phosphate, and Gazi University has identified GALNT3 as the responsible gene. Charles River will supply Gazi University with off-the-shelf research-grade AAV plasmids, offering a pre-manufactured and ready-to-use option for early-stage gene therapy programs. These plasmids are produced with animal component-free methods and are royalty-free, designed to accelerate projects and reduce costs.

“We are very happy to enter this strategic collaboration, bringing together academic innovation and CDMO expertise to accelerate the development of advanced therapies,” commented Prof. Fatih Ezgü, MD, Professor of Pediatrics and Head of the Department of Pediatric Genetics at Gazi University Faculty of Medicine. “This partnership marks a significant milestone in our mission to pioneer transformative therapies for rare diseases, and we look forward to the progress we can achieve together.”

Cell and Gene Therapy CDMO Solutions

Committed to streamlining the development of advanced therapies from concept to cure, Charles River has established an industry-leading cell and gene therapy portfolio, integrating discovery and safety assessment services, biologics testing, and pre-clinical through commercial-scale manufacturing solutions for plasmid DNA, viral vectors, and cell therapies.

Explore the challenges and considerations for plasmid DNA throughout CGT development, from plasmid selection in drug discovery and future-proofing strategies, to navigating the translation to clinic and beyond. Access guidebook: https://bit.ly/483LrER

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/20260121488189/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.