Charles River Announces Agreement with Singapore General Hospital
Charles River Laboratories (NYSE: CRL) has entered an agreement with Singapore General Hospital (SGH) to provide CGMP-compliant master cell banking and next-generation sequencing (NGS) services. These services will aid in the characterization of cell lines derived from cord blood for allogeneic CAR-T cell production, aimed at treating cancer patients.
SGH will utilize Charles River's CGMP master cell banking services and NGS-based testing for their upcoming Phase I clinical trials. The NGS technology offers high throughput, scalability, and speed, revolutionizing genetic analysis and pathogen detection. It provides a more efficient and reliable testing option compared to traditional animal-based testing.
Charles River's services ensure compliance with GMP, FDA, EMA, and ICH Q5A and Q5B standards, accelerating development timelines without compromising safety. The company offers a full range of CGMP-compliant cell bank production and storage services, including 9 ISO-6 cleanroom suites and a cell bank completion to release timeline of 8-10 weeks.
Charles River Laboratories (NYSE: CRL) ha stipulato un accordo con Singapore General Hospital (SGH) per fornire servizi di banking cellulare master conformi a CGMP e servizi di sequenziamento di nuova generazione (NGS). Questi servizi aiuteranno nella caratterizzazione delle linee cellulari derivate dal sangue del cordone ombelicale per la produzione di cellule CAR-T allogeniche, destinate a trattare i pazienti affetti da cancro.
SGH utilizzerà i servizi di banking cellulare master CGMP di Charles River e i test basati su NGS per i loro prossimi studi clinici di Fase I. La tecnologia NGS offre un'elevata capacità di elaborazione, scalabilità e velocità, rivoluzionando l'analisi genetica e la rilevazione di patogeni. Fornisce un'opzione di test più efficiente e affidabile rispetto ai test tradizionali basati su animali.
I servizi di Charles River garantiscono la conformità agli standard GMP, FDA, EMA e ICH Q5A e Q5B, accelerando i tempi di sviluppo senza compromettere la sicurezza. L'azienda offre un'ampia gamma di servizi di produzione e stoccaggio di banche cellulari conformi a CGMP, comprese 9 suite di camere bianche ISO-6 e un tempo di completamento della banca cellulare fino al rilascio di 8-10 settimane.
Charles River Laboratories (NYSE: CRL) ha firmado un acuerdo con Singapore General Hospital (SGH) para proporcionar servicios de banca celular maestra conformes a CGMP y servicios de secuenciación de nueva generación (NGS). Estos servicios ayudarán en la caracterización de líneas celulares derivadas de sangre de cordón umbilical para la producción de células CAR-T alogénicas, destinadas a tratar a pacientes con cáncer.
SGH utilizará los servicios de banca celular maestra CGMP de Charles River y pruebas basadas en NGS para sus próximos ensayos clínicos de Fase I. La tecnología NGS ofrece alta capacidad de procesamiento, escalabilidad y rapidez, revolucionando el análisis genético y la detección de patógenos. Proporciona una opción de prueba más eficiente y confiable en comparación con las pruebas tradicionales basadas en animales.
Los servicios de Charles River aseguran el cumplimiento de las normas GMP, FDA, EMA e ICH Q5A y Q5B, acelerando los plazos de desarrollo sin comprometer la seguridad. La empresa ofrece una gama completa de servicios de producción y almacenamiento de bancos celulares conformes a CGMP, incluyendo 9 salas limpias ISO-6 y un tiempo de finalización de la banca celular hasta el lanzamiento de 8-10 semanas.
찰스 리버 연구소 (NYSE: CRL)는 싱가포르 종합병원 (SGH)과 CGMP 준수 마스터 세포 뱅킹 및 차세대 시퀀싱(NGS) 서비스를 제공하는 계약을 체결했습니다. 이 서비스는 암 환자를 치료하기 위한 동종 CAR-T 세포 생산을 위해 제대혈에서 유래한 세포주 특성화에 도움이 될 것입니다.
SGH는 다가오는 1상 임상 시험을 위해 찰스 리버의 CGMP 마스터 세포 뱅킹 서비스와 NGS 기반 테스트를 활용할 것입니다. NGS 기술은 높은 처리량, 확장성 및 속도를 제공하며, 유전 분석 및 병원체 탐지를 혁신합니다. 이는 전통적인 동물 기반 테스트에 비해 더 효율적이고 신뢰할 수 있는 테스트 옵션을 제공합니다.
찰스 리버의 서비스는 GMP, FDA, EMA, ICH Q5A 및 Q5B 기준을 준수하여 안전성을 저해하지 않으면서 개발 일정을 가속화합니다. 이 회사는 9개의 ISO-6 클린룸과 8-10주 내에 세포 뱅크 완공을 포함하여 CGMP 준수 세포 뱅킹 생산 및 저장 서비스의 전체 범위를 제공합니다.
Charles River Laboratories (NYSE: CRL) a conclu un accord avec Singapore General Hospital (SGH) pour fournir des services de banque cellulaire maître conformes aux CGMP et des services de séquençage de nouvelle génération (NGS). Ces services aideront à la caractérisation des lignées cellulaires dérivées du sang de cordon ombilical pour la production de cellules CAR-T allogéniques, destinées à traiter les patients atteints de cancer.
SGH utilisera les services de banque cellulaire maître CGMP de Charles River et des tests basés sur NGS pour ses prochains essais cliniques de Phase I. La technologie NGS offre un haut débit, une évolutivité et une rapidité, révolutionnant l'analyse génétique et la détection des pathogènes. Elle fournit une option de test plus efficace et fiable par rapport aux tests traditionnels basés sur les animaux.
Les services de Charles River garantissent la conformité aux normes GMP, FDA, EMA et ICH Q5A et Q5B, accélérant les délais de développement sans compromettre la sécurité. L'entreprise propose une gamme complète de services de production et de stockage de banques cellulaires conformes aux CGMP, y compris 9 salles blanches ISO-6 et un délai de réalisation de la banque cellulaire de 8 à 10 semaines.
Charles River Laboratories (NYSE: CRL) hat eine Vereinbarung mit Singapore General Hospital (SGH) getroffen, um CGMP-konforme Master-Cell-Banking- und Next-Generation-Sequencing (NGS)-Dienste anzubieten. Diese Dienste werden bei der Charakterisierung von Zelllinien, die aus Nabelschnurblut gewonnen werden, für die Herstellung von allogenen CAR-T-Zellen helfen, die zur Behandlung von Krebspatienten eingesetzt werden.
SGH wird die CGMP-Master-Cell-Banking-Dienste und NGS-basierten Tests von Charles River für ihre bevorstehenden Phase-I-Studien nutzen. Die NGS-Technologie bietet hohe Durchsatzraten, Skalierbarkeit und Geschwindigkeit und revolutioniert die genetische Analyse und die Pathogendetektion. Sie bietet eine effizientere und zuverlässigere Testoption im Vergleich zu traditionellen tierversuchsbasierenden Tests.
Die Dienstleistungen von Charles River gewährleisten die Einhaltung der GMP-, FDA-, EMA- und ICH Q5A- und Q5B-Standards und beschleunigen die Entwicklungszeiten, ohne die Sicherheit zu gefährden. Das Unternehmen bietet ein umfassendes Angebot an CGMP-konformen Dienstleistungen zur Herstellung und Lagerung von Zellbanken, einschließlich 9 ISO-6-Reinräumen und einem Zeitrahmen von 8-10 Wochen für die Fertigstellung der Zellbank bis zur Freigabe.
- Agreement with SGH for CGMP-compliant cell banking and NGS services.
- Support for Phase I clinical trials for cancer treatment.
- NGS services enhance detection of viral contaminants.
- Accelerated development timelines without compromising safety.
- Compliance with GMP, FDA, EMA, and ICH standards.
- No financial details or revenue impact disclosed.
Insights
Charles River Laboratories has secured a strategic agreement with Singapore General Hospital (SGH) to provide CGMP-compliant master cell banking and next-generation sequencing services for SGH's allogeneic CAR-T cell therapy development program. This partnership directly strengthens CRL's position in the rapidly expanding cell and gene therapy testing market, which is projected to grow at a CAGR of approximately 15-20% through 2030.
The collaboration is particularly noteworthy as it focuses on allogeneic ("off-the-shelf") CAR-T therapies derived from cord blood, representing a significant advancement over traditional autologous CAR-T approaches. Allogeneic therapies can potentially serve multiple patients from a single manufacturing run, dramatically improving scalability and reducing per-patient costs - a critical factor for commercial viability in emerging markets.
From a technical perspective, Charles River's NGS-based testing services offer substantial advantages over traditional methods. NGS technology enables comprehensive genomic screening with higher sensitivity and specificity, reducing testing timelines by 30-50% compared to conventional animal-based testing approaches. This efficiency translates to accelerated development timelines for clients while maintaining regulatory compliance - a compelling value proposition in the time-sensitive cell therapy development landscape.
The agreement leverages Charles River's extensive infrastructure, including 9 CGMP-compliant ISO-6 cleanroom suites and capabilities that support programs from early research through commercial manufacturing. This established expertise creates significant barriers to entry for potential competitors and positions CRL as a preferred partner for similar collaborations across the Asia-Pacific region.
While financial terms remain undisclosed, this type of specialized service typically commands premium pricing with higher margins than traditional preclinical services. The cell characterization market segment generally yields operating margins in the 25-30% range, compared to the company's overall operating margin of approximately 19-20%.
Beyond immediate financial implications, this partnership enhances Charles River's credibility in the advanced therapeutics space and aligns with its strategic focus on supporting novel modalities. The collaboration with a prestigious institution like SGH could catalyze additional partnerships throughout the APAC region, where biopharma R&D investment is growing at nearly twice the global average rate.
For investors, this agreement represents another data point supporting Charles River's successful execution of its long-term strategy to expand capabilities in high-growth, specialized service areas while diversifying geographically into emerging markets with significant biopharma investment potential.
Charles River to provide master cell banking and NGS testing services for cord blood derived allogeneic CAR-T cells
“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
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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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.
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