Charles River has a strong drug discovery background in infectious diseases and the assessment of novel antimicrobials, antivirals, and vaccines using established in vitro assays and in vivo models. Our in-house expertise enables us to work with you in designing experiments, optimally, to determine the efficacy of anti-infectives. We can support you in early proof of concept and the selection of your key candidate drugs.
We provide animal models, free of select infectious agents and parasites, to further your infectious disease research. And, if your research requires the use of specialized models, our experts will work with you to customize and create them for your study using the latest model creation technology. In addition, our microbiology services can screen for pathogenic bacterial species.
Basic Research Products and Services
We test the efficacy of novel antimicrobials, antivirals and vaccines using bespoke, validated in vitro, ex vivo, and in vivo infection models. Our experts can adapt models to provide you with key data on specific pathogens early in your research program to inform your decision-making.
Our assays include MIC, MBC, time-kill, cell-based, immune modulation, Galleria mellonella, sepsis, lung, urinary tract, wound, and flu infection models. For bacterial studies, we use both a range of Gram-negative and Gram-positive strains, which include clinical isolates, resistant strains as well as bioluminescent strains, enabling in-life analysis and temporal monitoring of infection.
With decades of experience in the field, we can advise on selecting the appropriate biomarkers, analytical methodology, pathology services, and toxicology endpoints to best demonstrate an immune or anti-infective response and explore potential safety issues with your therapeutic product (including small molecule anti-infectives, peptide- or viral-based vaccines, or more novel therapies such as a DNA or RNA vaccines and phage therapy). In addition to conducting nonclinical studies in support of the development program, our experts help to design scientifically sound programs based on the mode of action of your drug, the disease indication, and your specific needs.
Our Biosafety Level 2 (BSL2) barrier facilities (PDF available through The Source℠) can deliver results under high regulatory standards and at a competitive price. We can conduct vaccine safety (and efficacy) studies in the following species as well as challenge work under BSL2 conditions:
• Guinea pig
• Large animals
Endpoints and capabilities include:
• BSL2 laboratory and vivarium space
• Bacterial enumeration in tissues and organs
• Inoculation routes, including but not limited to intratracheal, nasal, intravaginal, and intramuscular options
• BSL2 challenge studies (with a few exceptions based on review of the challenge material)
• Frozen bacterial stocks and ATCC availability
• Antigen-specific responses (titering and isotyping)
• T helper cell (Th1/Th2) ex vivo analysis
Safety Assessment Services
We offer full-service support across the entire drug discovery and development continuum, including many products and services not specific to therapeutic area or indication.
Serving the needs of both small and large molecule developers, we offer a broad range of standard and specialized laboratory services to complement and enhance drug development programs, from discovery through safety and clinical trials. From complete IND-enabling programs to stand-alone assessments, our Safety Assessment team provides a full range of in vivo and in vitro testing services that comply with worldwide regulatory restrictions for the preclinical development of pharmaceuticals.
We provide a comprehensive range of testing programs and equipment to support pharmaceutical development. Our biologics testing solutions and portfolio of microbial quality control systems and services help clients ensure the safety, quality and compliance of their products. We support large molecule manufacturing from early preclinical formulation development through clinical and commercial manufacturing and release.
Exceptional support of the entire drug discovery and development process is a Charles River hallmark. As a customer-focused organization committed to advancing science and helping clients reach their goals, we continually strive to develop solutions that extend our support of their efforts. Because our industry-seasoned professionals have followed the same journey as our clients, we can provide insight into the bigger picture, advice on best practices, skilled staff to extend resources and targeted training to meet the unique challenges they face along the way.