Charles River has the necessary understanding of ocular diseases along with the technical ability and experience to guide our clients’ new drugs and treatments through the development process as efficiently as possible. Ocular effects of compounds administered by other routes, such as oral or intravenous, can also be characterized. These studies can be conducted under Good Laboratory Practice (GLP) conditions either as stand-alone studies or as part of general and specialty toxicology programs. Non-GLP pilot or proof-of-concept studies are also available for early research needs.
With breeding and service centers around the globe, Charles River can provide you with the models and services required to advance your ocular research and development programs. We are the leading provider of Long-Evans rats, Brown Norway rats, Sprague Dawley® rats, New Zealand white rabbits and other large animals. Information about other species, stocks and strains is available upon request.
Disease models with metabolic syndromes and diabetes can be spontaneous models for a variety of eye disorders. Retinopathy is a common complication for people with diabetes. We provide a broad range of disease models, including the Zucker Diabetic Fatty (ZDF) Rat for diabetic retinopathy studies, as well as a variety of hypertension rat models, such as the Spontaneously Hypertensive Rat (SHR) for ocular dysfunction studies.
Basic Research Products & Services
Charles River offers validated disease models that can be used for non-GLP screening studies and more definitive proof-of-concept studies for which we can advise on study designs. Board-certified veterinary ophthalmologists are readily accessible, and we maintain strong industry ties to leading experts in ophthalmology, neurophysiology and surgery. Our in vitro ocular irritation models may be used early in the development of a test article as a screen or during the GLP toxicology testing. Both screening and GLP versions of the BCOP, EpiOcular and HET-CAM are available.
Intraocular dosing presents a unique set of challenges due to limited volumes in small spaces; as such, knowledge of interspecies differences in ocular anatomy and limitations of animal models is essential. General anesthesia is usually required for intraocular dosing of animals and must be considered when planning the study design. At Charles River, we have an extremely low incidence (<0.001%) of adverse complications due to intraocular dosing procedures.
Case Study: Evaluating Multiple Vectors in a Single Eye
A custom surgical technique to create four independent subretinal injection sites within a single eye for a gene vector.
To assess adverse ocular effects, specialized equipment and capabilities are required. Slit lamp/indirect ophthalmology examinations, electroretinograms (ERG), and tonometry are the most common parameters evaluated in ocular toxicology studies for therapeutics delivered to the posterior of the eye. Additional parameters such as fluorescein/indocyanin green (ICG) angiography to investigate vascular integrity, OCT for non-invasive micron-level cross-sections of the retina or cornea, specular microscopy, and pachymetry to determine corneal thickness can be employed.
In studies employing an ocular route of administration or involving the development of intraocular devices, histopathological evaluation of the eyes is far more rigorous than in standard toxicology studies. Charles River’s industry leading ocular pathology team can provide guidance on which techniques you should incorporate into your study design. We also offer an extensive array of histochemical and immunohistochemical staining techniques, electron microscopy services and morphometry expertise.
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.