Charles River Laboratories International, Inc., together with its subsidiaries, operates as a full service, non-clinical global drug development partner.
The company has built upon its original core competency of laboratory animal medicine and science (research model technologies) to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, that supports its clients from target identification through non-clinical development. It al...
Charles River Laboratories International, Inc., together with its subsidiaries, operates as a full service, non-clinical global drug development partner.
The company has built upon its original core competency of laboratory animal medicine and science (research model technologies) to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, that supports its clients from target identification through non-clinical development. It also provides a suite of products and services to support its clients’ manufacturing activities.
The company’s client base includes major global pharmaceutical companies, many biotechnology companies; agricultural and industrial chemical, life science, veterinary medicine, medical device, diagnostic and consumer product companies; contract research and contract manufacturing organizations; and other commercial entities, as well as leading hospitals, academic institutions, and government agencies around the world.
The company operates in over 130 sites and in over 20 countries worldwide (excluding certain Insourcing Solutions sites). Its products and services, supported by its global infrastructure and deep scientific expertise, enable its clients to overcome many of the challenges of non-clinical life sciences research.
Segments
The company has three reportable segments: Research Models and Services (RMS), Discovery and Safety Assessment (DSA) and Manufacturing Solutions (Manufacturing).
Through the company’s RMS segment, it has provided foundational tools for the discovery of new molecules by supplying research models to the drug development industry since 1947. The company continues to maintain its position as a global leader in the production and sale of the most widely used research models, including over 140 different stocks and strains of purpose-bred rodents. It also provides a variety of related services that are designed to support its clients in the use of research models in drug discovery and development. The company maintains multiple production centers, including barrier rooms and isolator facilities, on three continents (North America, Europe, and Asia). It is also a premier provider of high quality, purpose bred, large research models to the biomedical research community. The company’s RMS segment also includes its Insourcing Solutions business, which includes its CRADL (Charles River Accelerator and Development Lab) footprint.
The company’s DSA segment provides services that enable its clients to outsource their innovative drug discovery research, their related non-clinical and clinical bioanalytical activities, and regulatory-required safety testing of potential new drugs, vaccines, industrial and agricultural chemicals, consumer products, veterinary medicines and medical devices. The demand for these services is driven by the needs of large global pharmaceutical companies where outsourcing may complement internal activities, in addition to mid-size and emerging biotechnology/biopharma pharmaceutical companies, hospitals, academic institutions, contract research organizations, and industrial and agrochemical companies and non-governmental organizations that rely more heavily on outsourcing partners.
The company is the largest provider of outsourced drug discovery, non-clinical development and regulated safety testing services worldwide. It has extensive expertise in the discovery of clinical candidates and in the design, execution and reporting of safety assessment studies for numerous types of therapeutic modalities, including cell and gene therapies, small and large molecule pharmaceuticals, industrial and agricultural chemicals, vaccines, consumer products, veterinary medicines, biocides and medical devices. The company provides discovery and safety assessment services at multiple facilities located in the United States (U.S.), Canada, and Europe.
Within the company’s Manufacturing segment, it works with its clients and the biopharmaceutical industry to ensure the quality and safe production and release of commercial therapies and products manufactured both by its clients and internally for its clients. The company’s Manufacturing Segment comprising two businesses: Microbial Solutions and Biologics Solutions. Its Microbial Solutions products and services businesses provide in vitro methods for conventional and rapid quality control testing of sterile and non-sterile pharmaceuticals and consumer products. Biologics Solutions is consisted of both its Biologics Testing Solutions business, which provides specialized testing of biologics frequently outsourced by global pharmaceutical and biotechnology companies, and its contract development and manufacturing products and services (CDMO) business, which provides comprehensive contract development and manufacturing solutions for cell and gene therapies.
Research Models and Services: The company’s RMS segment comprising three businesses that provide foundational tools that enable its clients to discover new molecules: Research Models, Research Model Service, and Cell Solutions.
Research Models: The company’s Research Models business is principally consisted of the production and sale of the most widely used small research models, primarily rodents. A significant portion of its Research Models business involves the commercial production and sale of small research models, principally purpose-bred rats and mice for use by researchers in fundamental biology through to drug discovery and development. The FDA and foreign regulatory agencies typically require that the safety and efficacy of new drug candidates be tested on research models like its prior to testing in humans. As a result, its research models are an essential part of the drug discovery and development process.
The company provides its research models to numerous clients around the world, including most pharmaceutical companies, a broad range of biotechnology companies, contract research organizations and many government agencies, hospitals, and academic institutions. It has a global footprint with production facilities strategically located in 7 countries, in close proximity to major biohubs and client concentrations. Its research models include commonly used laboratory strains, disease models and specialized strains with compromised immune systems, which are in demand as early-stage tools in the drug research and development process.
The research models the company supplies have been, and continue to be, some of the most extensively used in the world, largely as a result of its geographic footprint and continuous commitment to innovation, quality, and biosecurity. Its research models are bred and maintained in controlled environments, which are designed to ensure that the models are free of specific viral and bacterial agents and other contaminants that can disrupt research operations and distort scientific results. With the company’s production capabilities, it is able to deliver consistently high-quality research models worldwide.
The company’s small research models include inbred, outbred, and hybrid strains, as well as mutant strains, genetically engineered models and humanized models with biological features, which enable research aims. Certain of its research models are proprietary rodent models used to research treatments in several therapeutic areas. The company is also a premier provider of high quality, purpose bred, large research models to the biomedical research community. While it provides some non-human primates directly to clients who utilize them primarily for safety testing of new therapies, most of the non-human primates associated with its business are utilized in connection with its clients’ studies conducted by its Safety Assessment services in its DSA business. In both cases - non-human primates the company provides directly to clients and non-human primates which are utilized through its Safety Assessment services – these large research models are sourced from Charles River audited and approved suppliers, some of which it has an ownership and/or operational involvement.
Research Model Services: RMS offers a variety of flexible solutions designed to support its clients' use of research models in basic research and screening pre-clinical drug candidates. These services address the need among pharmaceutical and biotechnology companies to outsource the non-core aspects of their drug discovery activities. The company’s services include those related to the maintenance and monitoring of research models, and managing research operations for government entities, academic organizations, and commercial clients. Its expanded service offering provides greater flexibility for its clients’ research and supports increased scientific complexity. The company has three service offerings in research models services: Insourcing Solutions, Genetically Engineered Models and Services (GEMS), and Research Animal Diagnostic Services (RADS).
Insourcing Solutions: The company manages the research operations of government entities, academic organizations and commercial clients (including recruitment, training, staffing and management services) both within its clients’ facilities and utilizing its Charles River Accelerator and Development Lab (CRADL) offerings, where it provides vivarium space to its clients. Some research institutions prefer to retain certain elements of their research in-house, while outsourcing staffing and management, thus driving demand for its services. The company’s expertise in early-stage drug research, and in particular research model care, scientific and technical support, facility operations, and discovery and development services, enhances the productivity and quality of its clients’ research programs.
Genetically Engineered Models and Services: The company creates, breeds, and maintains research models required by its clients for biomedical research activities. The creation of a genetically engineered model (GEM) is a critical scientific event, but it is only one step in the discovery process, and its scientists can advise clients on how to efficiently create custom models utilizing in-licensed technologies and approaches to modify the genome. Productive utilization of GEMs requires significant additional technical expertise in order to properly support basic and early discovery research. The company provides breeding expertise and colony expansion, quarantine, health and genetic testing and monitoring, germplasm cryopreservation and rederivation, including assisted reproduction and model creation. Its team of project managers is supported by a proprietary, technologically advanced Internet Colony Management (ICM) system that allows for real-time data exchange. It provides these services to clients around the world, including pharmaceutical and biotechnology companies, hospitals, universities, and government agencies.
Research Animal Diagnostic Services: The company monitors and analyzes the health profiles of its clients’ research models and research biologics by assessing infectious agents and pathology. The company developed this capability internally to address the quality control of its research model business. It can serve as its clients’ sole-source testing laboratory, or as an alternative source supporting its clients’ internal laboratory capabilities. The company is the reference laboratory of choice for health assessment of laboratory research models and an industry leader in the field of laboratory animal diagnostics.
Cell Solutions: The company’s Cell Solutions business provides consenting human donor-derived cellular materials used in the development and production of cell therapies. The business supplies controlled, consistent, customized primary cells and blood components derived from normal and mobilized peripheral blood and bone marrow, as well as cells from disease state donors. Its Cell Solutions business supports biotechnology and pharmaceutical companies, academic institutions and other research organizations who rely on high-quality, viable and functional human primary cells and blood components for biomedical and drug discovery research and cell therapy development, including clinical trials.
Discovery and Safety Assessment
The company offers regulated and non-regulated DSA services to support the discovery, development, and regulatory-required safety testing of potential new drugs, including in vitro and in vivo studies, laboratory support services, including bioanalytical and strategic non-clinical consulting and program management.
In 2025, the company initiated the integration of its Discovery Services and Safety Assessment businesses into one overarching DSA organization. This unification focuses on a combined sales force and leadership approach, with integrated scientific expertise to facilitate a more seamless client experience and make it a stronger and even more responsive partner for its clients.
Discovery Services: The company offers a single source of services for discovering and characterizing novel drug candidates for preclinical development by providing a full spectrum of discovery services — from identification and validation of novel targets, low molecular weight small molecule compounds, oligonucleotides, and biotherapeutics with actual or potential intellectual property value, through to delivery of preclinical drug and biotherapeutic candidates ready for safety assessment and progression toward the clinic. This includes services to streamline and enhance drug discovery programs for its clients, including expertise and capabilities in all stages of discovery and all major modalities, including small molecules, biologics (antibodies), oligonucleotides, and cell and gene therapies. In the discovery phase, it leverages its capabilities in non-GLP toxicity assessment and predictive models to enable identification and mitigation of safety issues to ensure a smooth progression into regulatory safety assessment. It has in depth capabilities in formulation and pharmaceutics to provide seamless transfer of optimized drug substance from the discovery phase into pre-clinical development and safety assessment. Its Safety Assessment teams can flag unexpected issues observed in regulatory toxicology to its Discovery Services team that might be resolved by further optimization within Discovery Services, enabling clients to potentially regain momentum in pre-clinical programs after resolution of the issues. The company’s seamless offering portfolio, along with its broad expertise and capabilities allow it to better engage with clients at any stage of their drug discovery programs and support their complex scientific needs. The company focus on major therapeutic areas, with a strategic emphasis on neuroscience, oncology, and immunology.
The company is a leader in integrated drug discovery services. Its full suite of service offerings, together with its knowledge and expertise, allows it to engage and support the company’s clients at any stage of their discovery or early-stage development programs, including the design and implementation of their research programs, and to stay with them through the entire drug discovery process, providing a seamless end-to-end offering. The company’s offerings include:
Target discovery and validation;
Disease biology;
Target deconvolution through proteomics and cell microarray technology;
Hit identification, hit-to-lead progression and lead optimization to deliver candidate molecules and biotherapeutics across modalities, making use of state-of-the-art techniques, such as computer-aided drug design, structural biology, and machine learning/artificial intelligence;
Early non-clinical pharmacokinetic and pharmacodynamic studies, transporter-mediated drug-drug interaction, and in vitro and in vivo assays to assess mechanism, bioavailability, and metabolism as required for regulatory approval;
Appropriate in vivo Discovery Services evaluation, which is essential to generate confidence in the initial safety of a novel therapeutic agent, its fate in an intact mammalian system and its potential to translate into an efficacious treatment in humans; and
Target engagement and safety biomarker development to support non-clinical and potentially downstream clinical studies.
Safety Assessment: The company offers a full range of safety assessment studies required for regulatory submission on a global basis across all therapeutic areas in the pharmaceutical, biotechnology, industrial chemical, agrochemicals, consumer products, veterinary medicines and medical devices industries. It is a global leader in both non-regulated and regulated GLP outsourced safety assessment services and provide expertise in a variety of therapeutic areas and modalities.
Toxicology: In addition to offering standard toxicology services, the company also provides a broad range of specialty toxicology offering from inhalation and infusion to developmental and reproductive toxicology. Its services include an extensive offering of capabilities and study types designed to identify possible safety risks, as well as a comprehensive offering of in vitro and in vivo studies for the support of general toxicology (acute, sub-acute and chronic studies), genetic toxicology, safety pharmacology, off-target screening, receptor identification profiling, reproductive and developmental toxicology, juvenile toxicology, and carcinogenicity bioassays that are required for regulatory submissions supporting first-in-human to first-to-the-market strategies for potential human therapeutics. Additionally, the company supports safety studies in numerous specialty areas, including cell and gene therapies, ecotoxicology, environmental risk, musculoskeletal toxicology, neurotoxicology, ocular toxicology, ototoxicology, and phototoxicology. It has expertise in the design and execution of development programs for the support of a broad diversity of therapeutic modalities in numerous laboratory species and test systems. The company also supports safety studies to test industrial chemical, agrochemicals, consumer products, veterinary medicines and medical devices. For human pharmaceutical candidates, once a lead candidate is selected, toxicology studies are required to support clinical trials in humans and for regulatory approval. These toxicology studies focus on assessing the safety of the potential therapeutic to determine if administration to humans might cause any unintended harmful effects. For new chemicals, industrial chemicals, agrochemicals, veterinary medicines, consumer products and medical devices, safety studies are performed to identify potential hazards to humans and the environment and are required for regulatory registration. Toxicology studies performed for any of these compounds are typically performed using in vitro and in vivo research models to identify any potential adverse effects that a compound has on an organism or tissue over a variety of doses and over various time periods of exposure.
Pathology Services: The ability to identify and characterize clinical and anatomic pathologic changes is critical in determining the safety and efficacy of potential new therapeutics, industrial and agricultural chemicals, veterinary medicines, and medical devices. Key go/no-go decisions regarding continued product development are typically dependent on the identification, characterization and evaluation of fluid, tissue and cellular changes that its experts identify and interpret for its clients. The company employs many highly trained veterinary anatomic and clinical pathologists and other scientists who use state-of-the-art techniques to identify potential test item-related changes. In addition to all standard anatomic and clinical pathology techniques, it provides specialized evaluations, such as digital primary and peer review histopathology options, cytology, platelet function, assay development, immunohistochemistry, in situ hybridization, image analysis, tissue morphometry, and spatial analysis services.
Safety Pharmacology: The company’s clients are also required to conduct an assessment of safety pharmacology. This suite of studies is used to determine any effects on the vital organ systems of the body - cardiovascular, respiratory and central nervous system (CNS). Along with heart rate and blood pressure measurements, the cardiovascular assessment will also assess if the test article has the potential to alter cardiac ion channel currents and prolong the cardiac QT interval of the electrocardiogram. Additionally, effects on the CNS and respiratory systems are assessed to complete the battery of studies to evaluate the vital organ systems of the body. Supplemental studies can also be performed to assess the renal, gastrointestinal and autonomic nervous systems, as well as dependency potential. It has in vitro, ex vivo (use of cells, tissues or organs outside of an in vivo system) and in vivo assays and perform the screening prior to the initiation of first-in-human clinical trials. The company’s capabilities can also be used to investigate the mode of action behind an adverse effect found in a safety assessment study.
Bioanalysis, Drug Metabolism and Pharmacokinetics: For the support of non-clinical drug safety testing and new chemical development, its clients are required to demonstrate appropriate stability in the collected biological sample, pharmacokinetics of their drug or compound in circulation, the presence of metabolites and, in the case of biologics, the presence or absence of anti-drug antibodies. The company has scientific expertise in the sophisticated bioanalytical techniques required to satisfy these requirements for many drugs and chemicals. Once analysis is complete, its scientists evaluate the data to provide information on the pharmacokinetics and/or toxicokinetics of the drug or chemical and complete an evaluation of the biologic disposition of the drug or chemical and its potential metabolites. Pharmacokinetics refers to the understanding of what the body does to a drug or compound administered at therapeutic dose levels, including the process by which the drug is absorbed, distributed in the body, metabolized and excreted. Toxicokinetics refers to the same understanding as applied at higher doses that may result in adverse effects. These studies are routinely required for the full non-clinical assessment of the disposition of the drug or chemical and the results are used in the safety evaluation of the compound. After performing sample analysis for the support of non-clinical studies, it also supports the clinical bioanalysis required in clinical trials for drug development. In addition, its Laboratory Sciences group is able to measure a wide range of non-clinical and clinical biomarkers related to the safety and efficacy of the drugs and/or chemicals being developed.
The company’s Safety Assessment facilities comply with animal welfare and GLP regulations to the extent required by the FDA, Environmental Protection Agency, United States Department of Agriculture (USDA), Centers for Disease Control and Prevention (CDC), European Medicines Agency, European Chemicals Agency and the Organization for Economic Co-operation and Development (OECD), Canadian Council on Animal Care (CCAC), as well as other international regulatory agencies. Furthermore, its non-GLP and early-stage discovery work performed at its Safety Assessment facilities, which are not subject to GLP regulations, is typically carried out under a quality management system. Its Safety Assessment facilities and Manufacturing facilities are regularly inspected by regulatory compliance monitoring authorities, its clients’ quality assurance departments and its own internal quality audit program.
Manufacturing Solutions
The company’s Manufacturing Solutions segment comprising two businesses: Microbial Solutions and Biologics Solutions.
Microbial Solutions: The company’s Microbial Solutions business operates as a rapid, efficient testing platform for microbial detection and identification of sterile and non-sterile applications. Microbial Solutions is a premier global provider of in vitro methods for conventional and rapid quality control testing, including FDA-mandated lot release testing for sterile biopharmaceutical products. The products and services are provided by its Endosafe, Celsis, and Accugenix businesses, which produce, globally distribute and service a comprehensive portfolio of endotoxin testing, microbial detection and identification kits, reagents, instruments, software, accessories, and laboratory services to a broad range of companies manufacturing and releasing products from the pharmaceutical, biotechnology, medical devices and consumer products companies. Its Endosafe business provides lot release testing of medical devices and injectable drugs for endotoxin contamination. The company’s Celsis business provides rapid microbial detection systems for lot release testing, as well as raw materials and in-process for quality control testing in the pharmaceutical, medical device and consumer products industries. Its Accugenix business provides state-of-the-art microbial identification services and products for manufacturing in the biopharmaceutical, medical device, nutraceutical and consumer care industries. The company expects its comprehensive portfolio of offerings and global network of laboratories to drive increased adoption of its quality control testing solutions across both sterile and non-sterile applications.
Endosafe: The company is a market leader in endotoxin testing products and services, which are used for FDA-required quality control testing of injectable drugs and medical devices, their components, and the processes by which they are manufactured. Endotoxin testing is an in vitro process that uses a processed extract from horseshoe crabs, known as limulus amebocyte lysate (LAL). The LAL test is the first and most successful FDA-validated alternative to an in vivo test to date. Generally, the extraction of the raw materials for LAL does not harm the crabs, which are subsequently returned to their natural ocean environment. The company has worked closely with regulatory agencies in states where it collects to limit its impact on the horseshoe crab population and their surrounding environment.
One of the primary growth drivers in the company’s Microbial Solutions business is its FDA-approved line of next-generation endotoxin testing products. This line is based on the Endosafe Portable Testing System (Endosafe -PTS) technology, which allows rapid endotoxin testing in the central laboratory or manufacturing environment. In recent years, the company expanded the PTS product portfolio to include a multiple sample testing system known as the Endosafe-MCS (multi-cartridge system) and the first fully automated robotic system developed specifically for high-volume endotoxin testing, Endosafe-Nexus, to satisfy the demand of its clients who require higher sample throughput. The company has seen expanded use of this rapid endotoxin testing technology as clients transition from traditional methods to its rapid cartridge technology and are seeking to meet data integrity requirements with its automated systems and software solutions. In 2023, The company launched Endosafe Trillium, its animal-free recombinant test for endotoxin detection. Endosafe Trillium utilizes three biological proteins, which provides superior accuracy and testing outcomes to competitors’ single-protein recombinant alternatives, as well as equivalence to LAL-based testing method. Endosafe Trillium represents a next-generation solution to its industry-leading Endosafe bacterial endotoxin detection portfolio.
Celsis: The Celsis reagents and instrument systems are used for in-process and product-release testing to help ensure the safe and efficient manufacture of pharmaceutical and consumer products. Celsis products utilize adenosine triphosphate bioluminescence technology for the rapid detection of microbial contamination delivering definitive results for some applications as fast as 24 hours. The product range includes reagent kits, instruments, software and services. The Celsis Advance II, Celsis Accel, and Celsis Adapt instruments and software automate the process for rapid microbial detection. The company maintains a suite of products focused on sterility testing. Sterility testing is required prior to the release of sterile injectable products. The legacy method required a 14-day sample incubation period and was subjective. Using the Celsis protocol and instrumentation, clients can detect contamination within 6 days and make definitive product release decisions. It also offers Celsis Complete and Celsis Advantage services. The Celsis Complete services supply both the documentation and testing required as part of a client sterility technology method validation process. This assists clients to complete their validation process very quickly without utilizing their own personnel resources. The Celsis Advantage product supplies the required documentation needed for the clients to conduct their own internal validation. The Celsis Adapt is an accessory instrument for the Celsis rapid detection systems, which is used to prepare and concentrate samples and provide a rapid testing solution for advanced therapy medicinal products, cell therapies, gene therapies, and other cell-containing products.
Accugenix: The company’s Accugenix global lab network is the premier provider of ISO17025-accredited contract microbial identification services. Accugenix is an industry leader in species-level identification and strain typing of bacteria and fungi that are recovered from manufacturing facilities. Utilizing state-of-the-art and proprietary technologies, coupled with scientific expertise and analysis from a network of nine global labs, Accugenix excels in providing accurate, timely, and cost-effective microbial identification services and products required to meet internal quality standards and government regulations. Accugenix also offers an in- house solution with its Axcess instrument that allows clients to perform identification testing in their own lab with access to its proprietary library.
Biologics Solutions: The company’s Biologics Solutions (Biologics) business is consisted of its Biologics Testing Services business and CDMO business.
Biologics Testing Services
The company’s Biologics Testing Services business provides clients with analytical testing and related capabilities to support the safe manufacture of their biologic drugs, as well as a suite of manufacturing services to produce its clients’ advanced therapeutics.
The company’s current Good Manufacturing Practices (cGMP) testing services facilities also grow and store well-characterized early-stage client cell lines and virus seed stocks for later development or manufacture of therapeutic proteins and vaccines for clinical trials. It further designs and provides viral clearance programs according to GLP at its German facility and cGMP at its U.S. facility for Phase I, II and III human clinical studies, as well as for market authorization.
The company performs specialized testing of biologics frequently outsourced by pharmaceutical and biotechnology companies globally and are a partner in navigating the complex pathway to biologic effectiveness. Its laboratories in the U.S., Germany, Ireland and France provide timely and regulatory-compliant services in the areas of analytical, molecular biology, virology, cell-based bioassays, bioanalysis, immunochemistry, microbiology, cell biology, in vivo and in vitro studies and related services. The company provides analytical characterization, lot release and safety testing support for chemistry, manufacturing and controls and investigational new drug (IND) filings and confirm that biomanufacturing of clinical drug candidates and commercial drugs are consistent, correctly defined, stable and essentially contaminant free. This testing is required by the FDA, EMA and other international regulatory authorities for its clients to obtain new drug approvals, to maintain government-licensed manufacturing facilities and to manufacture and release market-approved therapeutic products for patient treatment.
The company continues to look for opportunities to expand its Biologics Testing Solutions service offerings and facilities in the U.S. and Europe. It has also commissioned a biosafety level 3 (BSL3) facility to provide in vivo and in vitro testing services for BSL3 materials, such as SARS-CoV2.
CDMO Services
The company’s CDMO business operates in the three major areas of the high-growth advanced therapy CDMO market: cell therapy, viral vector, and plasmid DNA production. Its CDMO services include expertise in gene-modified and unmodified cell therapy manufacturing coupled with capabilities in viral vector manufacturing, as well as plasma DNA. The company’s CDMO services establish it as a premier scientific partner for cell and gene therapy development, testing, and manufacturing. The fully integrated advanced therapeutics portfolio enables it to provide clients with an integrated solution from basic research and discovery through cGMP production, driving efficiency and accelerating clients’ speed-to-market by integrating preclinical CRO activities with manufacturing and testing. This provides its clients with a seamless experience across the value chain with the same advanced therapeutics scientific partner. The company’s cGMP CDMO facilities have the capability to manufacture and store raw materials, drug substance, and drug product, which are suitable for use in clinical trials, as well as for commercial manufacturing.
Strategy
The company’s strategy is to deliver a comprehensive and integrated portfolio of drug discovery and non-clinical development products, services and solutions to support its clients’ discovery and early-stage drug research, process development, scale up, manufacturing and product release efforts, and enable them to bring new and improved therapies to market faster and more cost effectively.
The key elements of the company’s strategy are integrated early-stage portfolio; comprehensive biopharmaceutical manufacturing portfolio; deep scientific expertise; commitment to animal welfare; superior quality and client support; flexible and customized environment to provide the right solutions; large, global partner; and digital enhancements.
The company’s long-term strategy also includes growth through establishing relationships and exploring other opportunities and areas that have the potential to strengthen its broad-based portfolio of products and services.
The company also partners with a diverse set of leading venture capital firms around the world primarily investing in life sciences, health care and therapeutics with an emphasis on early-stage companies.
Clients
The company’s clients consist primarily of major biopharmaceutical companies; many small, emerging, and established biotechnology, agricultural and industrial chemical, life science, veterinary medicine, medical device, diagnostic and consumer product companies; contract research and contract manufacturing organizations; and other commercial entities, as well as leading hospitals, academic institutions, government agencies, and non-governmental organizations.
Sales, Marketing and Customer Support
In addition to the company’s field sales teams and related specialists, it also has a team of alliance managers who are organized by key client within its market segments (global biopharmaceutical, small and mid-sized pharmaceutical and biotechnology companies, and academic and government institutions). This enhances its ability to meet client needs by offering customized, tailored solutions across its entire portfolio. In addition, the company’s clients benefit by additional support from a combination of technical specialists with specific scientific and therapeutic area expertise. It also applies the use of dedicated sales specialists for certain technical product lines, such as in its Manufacturing businesses.
The company sells its products and services principally through its direct sales and business development teams who work in North America, Europe, and Asia. In addition to interactions with the company’s direct sales force, its primary promotional activities include presenting scientific symposia to targeted audiences, publishing scientific papers, technical support pieces and white papers, and newsletters, hosting webinars and virtual seminars and making presentations at, and participating in, scientific conferences and trade shows in North America, Europe, and Asia. The company supplements these scientifically based marketing activities with digital marketing, advertising and website content. In certain areas, its direct sales force is supplemented by international distributors and agents.
Regulatory Matters
The company complies with licensing and registration requirement standards set by the United States Department of Agriculture (USDA) and U.S. Fish and Wildlife Service (USFWS), and similar applicable agencies in other global regions, such as Canada, Europe and China for the care, handling and oversight of regulated species. Its DSA and RMS facilities that work with or produce research animals in North America and Europe are accredited, with the exception of new and recently acquired facilities that are in the process of planning for accreditation, by AAALAC International, a private, nonprofit, independent accrediting organization that promotes the humane care and treatment of animals in science and education through voluntary accreditation and assessment programs.
Good Laboratory Practice (GLP) regulations describe a quality system for the scientific, operational and quality process and the conditions under which non-clinical studies are planned, performed, monitored, recorded, reported and archived. GLP compliance is required by such regulatory agencies as the Food and Drug Administration (FDA), European Medicines Agency, Medicines and Healthcare Products Regulatory Agency in the United Kingdom (U.K.), Health Products Regulatory Authority in Ireland, Health Canada and other similar monitoring authorities in the countries where the company operates.
The company’s Manufacturing businesses produce FDA regulated endotoxin test kits at an FDA registered facility. It also manufactures sterility and microbial limits test kits used in FDA Regulated pharmaceutical applications, reagents, cell banks used in research and biopharmaceutical production, clinical trial vaccines and vaccine support products, as well as an animal-free recombinant cascade reagent (rCR), Endosafe Trillium, which is an alternative to the natural LAL product.
The company’s comprehensive cell and gene therapy manufacturing services include Good Manufacturing Practices (GMP) production of cells from pre-clinical to commercial applications from a variety of starting materials. Many of these activities are subject to regulation and consequently require these businesses to be inspected by the FDA and other national and applicable state regulatory agencies under their respective cGMP regulations. These regulations require that it manufactures products or perform testing in a prescribed manner with respect to cGMP compliance, and maintain records of its manufacturing, testing and control activities.
History
Charles River Laboratories International, Inc. was founded in 1947. The company was incorporated in 1994.
