Each drug development program goal is different, and Charles River can work with you on your renal studies focused on efficacy, safety, endotoxin testing, and microbial identification. Our team of scientists can assist you in the different stages of drug development. Whether you require a fully integrated drug discovery program or an IND package, we are here to help you achieve your development goals. Charles River has a long history of experience in the field of kidney disease research and can provide a wide range of capabilities to assess current or potential new renal disease treatments in an effort to bring patients more efficient and effective drug solutions.
Kidney disease has a significant impact on global health worldwide. Current treatment options for the most severe forms of chronic kidney disease and kidney failure typically involve dialysis, which is a major burden on patients, caregivers and national health care budgets.
Kidney disease drug discovery and development is hampered not only by the many contributing factors involved in disease progression, but also by generally poor awareness of symptoms that leads to late clinical diagnosis. Nevertheless, researchers continue the pursuit of new therapies because of the critical medical need. There are a variety of approaches being considered, many of which target anti-inflammatory or antifibrotic mechanisms1.
Our chemists have experience working on many of these targets, and work hand-in-hand with biologists and pharmacologists who are experienced designing kidney disease efficacy studies. Whether you need a fully integrated program or a single efficacy study (in vitro or in vivo), our scientists can provide the support you need.
1Breyer MD and Katalin Susztak. Semin. Nephrol. 2016 Nov; 36(6): 436-447
There is a need to eliminate unpromising drug candidates as early as possible. In renal disorders, we offer a variety of models covering acute kidney injury to chronic kidney disease by leveraging expertise in procedures such as partial nephrectomies, renal ischemia-reperfusion injury, renovascular hypertension (Goldblatt 2-Kidney 1-Clip), and STZ-induced diabetes. The causes of kidney diseases are varied, but we can apply a variety of tools to assess potential new treatments.
Renal Disease Models
- • Aminoglycoside nephrotoxicity
- • Partial nephrectomies
- • Age-induced renal disfunction
- • Immunological methods of renal disfunction induction
- • Renal ischemia-reperfusion injury
- • Renovascular hypertension
- • Renal transplantation
- • Streptozotocin-induced diabetic nephropathy
Endpoint and Technical Capabilities
- • Serum renal biomarkers
- • Urine renal biomarkers
- • Transdermal GFR assessment
- • GFR assessment
- • Effective renal plasma flow assessment
- • Urine collection in metabolic cages
- • Immunohistochemistry
- • Microscopic examination of H & E stain, periodic acid-Schiff (PAS), and trichrome
Safety Assessment Services
Charles River offers comprehensive QC testing solutions to dialysis facilities to help improve the safety and quality of the water used in dialysis treatments delivered to their patients. Patients trust therapy to be administered safely; their lives depend on precision and sensitivity in your testing procedures.
Endotoxin Testing Systems
As the most sensitive and robust assay available, limulus amebocyte lysate (LAL) has transformed from a qualitative gel-clot assay to a 15-minute quantitative assay available right on the production floor. Our portfolio of FDA-licensed LAL products for rapid and traditional bacterial endotoxin testing was purposely built to deliver robust, consistent, and confident results. Our revolutionary FDA-licensed LAL cartridge technology is at the heart of all our rapid methods, improving sample management, decreasing testing time, and accelerating production. Flexible and easy-to-use, our solutions allow clients to perform real-time endotoxin testing, glucan concentration determination, and Gram identification at either the point of sample collection or in the central QC lab.
Products & Services
Contract Endotoxin Testing Services
Our bacterial endotoxin testing services laboratory offers comprehensive testing and support services to help improve the compliance and efficiency of your program and help you to achieve control, consistency, and precision in your lab. Our FDA-registered labs offer a variety of cGMP testing and support services.
- • Product validation programs
- • LAL proficiency testing program
- • Regulatory compliance consultation
- • Methods development
- • On-site training
- • Reader/software qualification
- • Product release/stability testing
- • Sample preparation
- • Routine endotoxin detection for non-release applications
- • SOP and protocol writing
Data gathered from a well-designed and executed environmental monitoring (EM) program provide critical information for tracking and trending on a routine basis. Accurate and consistent species-level identifications result in more confidence in the control of your environment.
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.