Charles River to provide master cell banking and NGS testing services for cord blood derived allogeneic CAR-T cells

Charles River Laboratories International, Inc. (NYSE: CRL) today announced an agreement with Singapore General Hospital (SGH) to provide Current Good Manufacturing Practice (CGMP) -compliant master cell banking (MCB) and next-generation sequencing (NGS)-based services for use in cell line characterization. SGH will use cord blood to derive and manufacture allogeneic chimeric antigen receptor (CAR) T-cells which will be used to treat patients with cancer.

“We are thrilled to leverage our cell line characterization services and comprehensive NGS testing approach to support SGH as they work to develop novel therapeutics for cancer patients,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River. “According to the World Health Organization, 1 in 5 individuals will develop cancer in their lifetime, so utilizing our decades of experience to help advance novel cancer research is aligned with our corporate values and goals.”

SGH will leverage Charles River’s CGMP MCB services for SGH’s critical starting material for its cord blood-derived allogeneic CAR T-cells and NGS-based testing services for cell line characterization services for its upcoming Phase I clinical trials.

Next Generation Sequencing

NGS is revolutionizing the way advanced therapeutics are characterized and tested to ensure high-quality products are delivered to patients. NGS has transformed the genetic analysis and pathogen detection landscape with its high throughput, scalability, and speed.

“As part of the cell characterization agreement, SGH will have access to Charles River’s CGMP NGS services, significantly increasing the capability of detecting viral contaminations in cell banks, providing a faster, more efficient, and reliable testing option compared to animal-based testing, and addressing their dynamic needs,” continued Dolph.

Charles River’s CGMP NGS testing services accelerate development timelines without compromising safety and meets regulatory requirements for accuracy, reliability, and compliance with GMP, FDA, EMA, and ICH Q5A and Q5B.

Biologics Testing Solutions

Backed by decades of cell banking and cell line characterization expertise, Charles River’s full range of CGMP-compliant cell bank production and storage services include 9 CGMP-compliant ISO-6 cleanroom suites, 8-10 week cell bank completion to release, and over 2,000 cell and viral banks produced supporting client programs from research and development through commercial manufacturing.

About Singapore General Hospital

Singapore General Hospital, established in 1821, is the largest tertiary hospital in Singapore and ranked among the world's best. It provides the most comprehensive patient-centered care with over 50 clinical specialties on its campus. As an Academic Medical Centre, it takes pride in training healthcare professionals and conducting cutting edge research to meet evolving needs of the nation as well as the region. Driven by a strong sense of purpose, SGH is committed to give its best to heal and bring hope, as it has for over 200 years. For more information, please visit www.sgh.com.sg.

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.

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