Charles River announces agreement with Singapore General Hospital

Charles River Laboratories International, Inc. has 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.

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.

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.

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.

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.

“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.

“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,” added Dolph.

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