Preclinical Services in Shrewsbury, MA

Designing a proper non-GLP toxicology study can help minimize the risk of failure during preclinical studies and help you decide if your program is suitable to move forward. Streamlined processes and documentation translate to faster and easier study initiation, and data and report delivery, for your non-GLP toxicity studies. Discover more about Acute non-GLP Toxicology.

Comprehensive preclinical bioanalysis is key at every stage of product development. At Charles River, bioanalytical services are intertwined with our discovery, preclinical, and clinical capabilities. From method development through clinical sample analysis, we are dedicated to performing accurate, reliable, and streamlined bioanalytical services for the most challenging programs to help you make confident research decisions.

We perform general toxicology studies under GxP regulations for the safety evaluation of drug, veterinary, chemical (agrochemical, industrial chemical, consumer products, cosmetics) and device development. Our wealth of knowledge allows us to advise and conduct standard and novel toxicology study designs, as well as deal with unexpected findings or toxicity issues during your program. Discover more about GLP Toxicology.

Pharmacology studies that employ relevant animal and cellular models of human disease can deliver efficacy data that accelerates your early research and proof-of-principle activities. Our team can help you select the best solution from our in vitro and in vivo models and assays or collaborate to design a custom test system that meets the needs of your therapy and program. Some area of focus include general pharmacology, cardiovascular and metabolic disease, custom studies for rare and orphan diseases, and more. Discover more about our in vivo pharmacology.

Each of our laboratories is a high-production environment that emphasizes tissue accountability during every step of preparation and processing. Our global anatomic pathology network has unparalleled capacity, allowing us to perform the histologic processing, histopathologic evaluation, and necropsy of several million tissue samples every year. Discover more about our necropsy, histology and histopathology.

Understanding the pharmacokinetics (PK) of a test article is an essential component of drug discovery. Realigning PK studies early in the discovery phase can assist in selecting an optimal drug candidate. We are able to support rapid bioavailability screening during drug candidate design, lead optimization, and compound selection.

Realignment of DMPK ADME studies earlier in discovery can assist in minimizing compound failure, define potency against a target with an acceptable safety profile, optimize PK parameters, and reduce drug-drug interactions (DDIs). Later, ADME will help validate toxicology studies, support safety evaluations prior to FIH, and indicate the likelihood of DDIs. Discover more about PK/PD and DMPK.

We offer a range of acute and chronic surgical models for use in any drug metabolism, pharmacology, or safety study type. Our research surgeons have extensive experience in the development of sophisticated surgical procedures in a variety of rodent and large animal species and are available to assist in the creation of the most relevant animal model for an enhanced understanding of your compound. Discover more about our surgical models.

A comprehensive assessment of pathologic changes is integral to preclinical and clinical studies for determining safety, efficacy, and mechanism of action for novel therapeutic agents. Charles River's Laboratory Pathology Services team features over 150 experts with multidisciplinary expertise in all types of drugs, biologics chemicals, and devices, offering several routine and specialized pathology services. Discover more about our anatomic and clinical pathology services.

Our global bioanalytical laboratories use a wide range of techniques and technology platforms to meet the needs of our customers. With 15 facilities worldwide, our expertise covers Chromatography, Mass spectrometry, Immunochemistry, Cell-based assays, Flow cytometry, Molecular biology, and more. Discover more about our bioanalysis services.

Data derived from biomarker services provide a valuable tool to determine disease progression or how the drug exerts its effects in terms of safety or efficacy. Charles River offers biomarker analysis services through a network of experts familiar with the multifaceted nature of biomarker selection, validation, and application from drug discovery to clinical sample analysis supporting decision making and mitigating risk at key stages of your program. Discover more about our biomarker services

Clinical trials are an exciting stage of drug development, the fruition of years of hard work. Timing is important to their cost-effective execution, and by working with our scientists, clients can front-load clinical timelines as early as the preclinical phase. This ongoing relationship results in a deep understanding of a client's work, and fosters continued collaboration across the clinical study team. Combined with our data management and transfer expertise, this approach allows us to produce detailed, on-time clinical data to support drug approval and help our clients effectively make sound go/no-go decisions. Discover more about our clinical support sciences.

As your integrated partner, we will ensure that you have the resources necessary to handle all of your laboratory support needs, from supplementing your in-house capabilities to providing complete study services. Our global capabilities can support the development of small and large molecule pharmaceuticals, as well as chemicals, agrochemicals, biocides and veterinary medicines. Discover more about our formulations and analytical chemistry services.

Preclinical imaging is an indispensable tool to evaluate the biological and physiological characteristics of therapeutics through the course of development for potential clinical application. We are committed to investing in human and physical capital to apply advanced imaging technologies and radiopharmaceutical production capabilities, providing translational support from discovery to clinical phases of development. Discover more about our imaging services.

We offer immunoanalytical services to measure anti-drug antibodies (ADAs) using a variety of techniques, including enzyme-linked immunosorbent assay (ELISA), electrochemiluminescence (ECL), and radioimmunoassay (RA). These techniques can detect both binding and neutralizing ADAs and can be customized to meet the specific needs of a particular drug development program.

Our global team of experts partners with you to develop the best translational path for your therapeutic, provide detailed regulatory expectations, and offer technical expertise in required assay formats. By using this comprehensive approach, you’ll have the most rapid and cost-effective program possible, from Proof of Concept, through safety assessment, and eventually to the clinic. Discover more about our immunology services.

We work with a diverse set of tools and platforms such as LC-MS, flow cytometry, electrochemiluminescence bead-based multiplexing assays, Quanterix, and Bdna assays.

We work with a range of drug modalities including small molecules, cell and gene therapies, conjugated antibodies, oligonucleotides, peptides, vaccines and medical devices.

The facility has over 90 animal rooms which are used to conduct studies in rodents, dogs, rabbits and non-human primates. These range from acute toxicology and dose range findings studies to general toxicology studies in a comprehensive offering of administration routes.