Charles River Laboratories International
Charles River Laboratories is dedicated to helping accelerate research and drug development, providing essential products and services from discovery to early development and manufacturing. They focus on creating healthier lives through world-class science, innovation, and a commitment to animal welfare, with a strong emphasis on scientific and regulatory guidance, and advancing alternatives to animal testing. Their mission is to bring vital drugs to market safely and quickly, with a responsibility to clients, patients, animals, and the scientific community.
Industries
Nr. of Employees
Very Large (1000+)
Charles River Laboratories International
Products
Recombinant endotoxin testing reagent (animal-free)
An animal-free recombinant reagent option for endotoxin testing designed to detect endotoxin without use of animal-derived reagents.
Cell microarray screening platform using non-human protein library
High-throughput cell microarray screening platform that uses a non-human protein library to profile off-target interactions and de-risk preclinical programs for regulatory submissions.
Recombinant endotoxin testing reagent (animal-free)
An animal-free recombinant reagent option for endotoxin testing designed to detect endotoxin without use of animal-derived reagents.
Cell microarray screening platform using non-human protein library
High-throughput cell microarray screening platform that uses a non-human protein library to profile off-target interactions and de-risk preclinical programs for regulatory submissions.
Services
IND-enabling studies and regulatory submission support
End-to-end IND-enabling programs including study design, GLP toxicology, regulatory documentation and submission support to interact with major regulatory agencies.
Cell and gene therapy CDMO and GMP manufacturing services
Scalable cGMP manufacturing and development services for cell and gene therapies including process development, tech transfer, and commercial production.
Research models and genetically engineered model services
Provision and customization of laboratory animal models, genetically engineered mouse and rat model creation, breeding, genotyping, and cryopreservation services to support discovery and preclinical research.
Bioanalysis and analytical testing services
Bioanalytical method development and regulated bioanalysis (PK, immunogenicity, biomarker assays) using chromatographic and mass spectrometry platforms to support preclinical and clinical programs.
Microbiology QC and endotoxin testing services
Endotoxin testing, contamination screening, and PCR-based pathogen surveillance for biologics and medical-device water systems, with animal-free reagent options where available.
New Approach Methodologies (NAMs) advisory and testing
Advisory, adoption, and testing services for NAMs including organoids, 3D models, in silico toxicology, virtual control groups and computational modeling to support reduction of animal use.
IND-enabling studies and regulatory submission support
End-to-end IND-enabling programs including study design, GLP toxicology, regulatory documentation and submission support to interact with major regulatory agencies.
Cell and gene therapy CDMO and GMP manufacturing services
Scalable cGMP manufacturing and development services for cell and gene therapies including process development, tech transfer, and commercial production.
Research models and genetically engineered model services
Provision and customization of laboratory animal models, genetically engineered mouse and rat model creation, breeding, genotyping, and cryopreservation services to support discovery and preclinical research.
Bioanalysis and analytical testing services
Bioanalytical method development and regulated bioanalysis (PK, immunogenicity, biomarker assays) using chromatographic and mass spectrometry platforms to support preclinical and clinical programs.
Microbiology QC and endotoxin testing services
Endotoxin testing, contamination screening, and PCR-based pathogen surveillance for biologics and medical-device water systems, with animal-free reagent options where available.
New Approach Methodologies (NAMs) advisory and testing
Advisory, adoption, and testing services for NAMs including organoids, 3D models, in silico toxicology, virtual control groups and computational modeling to support reduction of animal use.
Expertise Areas
- Regulatory compliance and IND submission support
- Safety assessment and toxicology (GLP and non-GLP)
- In vivo disease modeling and oncology research
- Cell and gene therapy development and GMP manufacturing
Key Technologies
- Patient-derived xenograft (PDX) models
- Humanized mouse models
- 3D in vitro cancer models and organoids
- Next-generation sequencing (NGS)