About Charles River Laboratories International

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 the company’s clients from target identification through non-clinical development. The company 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 155 sites and in over 20 countries worldwide (excluding certain Insourcing Solutions sites). The company’s products and services, supported by its global infrastructure and deep scientific expertise, enable the company’s 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, the company 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. The company also provides a variety of related services that are designed to support the company’s 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). The company 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 the company’s CRADL (Charles River Accelerator and Development Lab) footprint. In 2023, RMS accounted for 19.2% of the company’s total revenue. The company’s DSA segment provides services that enable the company’s clients to outsource their innovative drug discovery research, their related nonclinical and some clinical drug development 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 that continue to transition to an outsourced drug development model, in addition to mid-size and emerging biotechnology companies, industrial and agrochemical companies and non-governmental organizations that rely on outsourcing. These entities may choose to outsource their discovery, development and safety activities to reduce fixed costs and to gain access to additional scientific expertise and capabilities. The company is the largest provider of outsourced drug discovery, non-clinical development and regulated safety testing services worldwide. The company has extensive expertise in the discovery of nonclinical candidates and in the design, execution and reporting of safety assessment studies for numerous types of compounds 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. In 2023, the company’s DSA segment represented 63.3% of its total revenue. Within the company’s Manufacturing segment, the company 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 the company’s clients and internally for its clients. The company’s Manufacturing segment is consisted of two businesses: Microbial Solutions and Biologics Solutions. The company’s 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 the company’s Biologics Testing Solutions business, which provides specialized testing of biologics frequently outsourced by global pharmaceutical and biotechnology companies, and the company’s CDMO business, which provides comprehensive contract development and manufacturing solutions for cell and gene therapies. In 2023, Manufacturing accounted for 17.4% of the company’s total revenue from continuing operations. Research Models and Services Research Models and Services: The company’s RMS segment is consisted of three businesses that provide foundational tools that enable the company’s clients to discover new molecules: Research Models, Research Model Services 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 the company’s Research Models business involves the commercial production and sale of small research models, principally purpose-bred rats and mice for use by researchers. The FDA and foreign regulatory agencies typically require that the safety and efficacy of new drug candidates be tested on research models like the company prior to testing in humans. As a result, the company’s 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. The company has a global footprint with production facilities strategically located in 7 countries, in close proximity to major biohubs and client concentrations. The company’s 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 continues to be, some of the most extensively used in the world, largely as a result of the company’s geographic footprint and continuous commitment to innovation, quality, and biosecurity. The company’s 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, the company 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 and genetically engineered models with biological features, which enable research aims. Certain of the company’s 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 the company provides some non-human primates directly to customers who utilize them primarily for safety testing of new therapies, most of the non-human primates associated with the company’s business are utilized in connection with the company’s customers’ studies conducted by the company’s Safety Assessment business. In both cases - non-human primates the company provides directly to customers and non-human primates which are utilized in the company’s Safety Assessment business – these large research models are sourced from Charles River audited and approved suppliers, some of which the company has an ownership and/or operational involvement. Research Model Services: RMS offers a variety of flexible solutions designed to support the company’s 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. The company’s expanded service offering provides greater flexibility for the company’s 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 the company’s clients’ facilities and utilizing the company’s Charles River Accelerator and Development Lab (CRADL) offerings, where the company provides vivarium space to the company’s clients. Some research institutions prefer to retain certain elements of their research in-house, while outsourcing staffing and management, thus driving demand for the company’s 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 the company’s 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 the company’s 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. The company’s team of project managers is supported by a proprietary, technologically advanced Internet Colony Management (ICM) system that allows for real-time data exchange. The company 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. The company can serve as its clients’ sole-source testing laboratory, or as an alternative source supporting the company’s 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. The company’s 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’s DSA segment is consisted of two businesses: Discovery Services and Safety Assessment. The company offers regulated and non-regulated DSA services to support the research, development, and regulatory-required safety testing of potential new drugs, including therapeutic discovery and optimization plus in vitro and in vivo studies, laboratory support services, and strategic non-clinical consulting and program management to support product development. Discovery Services: The company’s Discovery Services business operates as a single source of services for discovering and characterizing novel drug candidates for preclinical development. The company offers a full spectrum of discovery services from identification and validation of novel targets, chemical compounds and antibodies with actual or potential intellectual property value through to delivery of preclinical drug and therapeutic candidates ready for safety assessment. The company’s Discovery Services business includes services to streamline and enhance drug discovery programs for the company’s clients, including expertise and capabilities in all stages of Discovery and all major modalities, including small molecules, antibodies and cell and gene therapies. This seamless discovery organization, along with its broad capabilities allows the company to better engage with clients at any stage of their drug discovery programs and support their complex scientific needs. The company’s Discovery Services business focuses on all of the major therapeutic areas, with a strategic focus on oncology, immunology and neuroscience. There are growing opportunities to assist the company’s clients in a variety of drug discovery applications and platforms from target discovery to candidate selection and across the full range of modalities. The company is a leader in integrated drug discovery services. The company’s full suite of service offerings, together with its knowledge and expertise, allows the company to engage and support its clients at any stage of their discovery or early-stage development programs, including the design and implementations of their research programs, and to stay with them through the entire drug discovery process. The company’s Discovery service capabilities include: Target discovery and validation; Target deconvolution through proteomics; Hit identification and optimization to deliver candidate molecules across modalities, including computer-aided drug design; Early nonclinical 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 of new drugs; In vivo Discovery Services, which are essential in early stage, non-clinical discovery research, and are directed at the identification, screening, optimization and selection of effective therapeutics agents in pharmacology models. These in vivo activities typically extend anywhere from 1 to 2 years in conventional pharmaceutical R&D timelines; and Target engagement biomarker development to support non-clinical and potentially downstream clinical studies. Additionally, the company offers ion channel and drug transporter testing for both discovery and non-clinical purposes. The company also provides these services at its clients’ laboratories with Charles River scientists as part of an insourcing service model. Through comprehensive in vivo and in vitro offerings, Discovery Services helps to reduce the time needed to research, develop, and assess the efficacy of new therapeutics under development. The company’s offerings include businesses that provide critical data to advance novel therapeutics, as well as drug transporter assays and kits. The company offers R&D expertise, capabilities and services globally to accelerate the company’s clients’ drug discovery pipelines from lead generation to candidate selection. The company complements and extends clients’ capabilities and expertise to improve their decision-making, increase their flexibility, and reduce their internal costs and product development timelines. Through strategic partnerships, the company also offers an artificial intelligence drug design platform, a human stem cell model platform, and 3D in vitro oncology models. 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. The company’s safety assessment business also provides expertise in a variety of therapeutic areas and modalities. The company’s Safety Assessment business is a global leader in both non-regulated and regulated (GLP) outsourced safety assessment services. Toxicology: The company provides a broad specialty toxicology offering from inhalation and infusion to developmental and reproductive toxicology. The company’s services include a broad offering of in vitro and in vivo capabilities and study types designed to identify possible safety risks as well as a broad offering of in vitro and in vivo studies in 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 abuse and seizure liability, ecotoxicology, environmental risk, musculoskeletal toxicology, neurotoxicology, ocular toxicology, ototoxicology, and phototoxicology. The company has expertise in the design and execution of development programs in 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 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 the company’s 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, the company provides specialized evaluations, such as cytology, platelet function, assay development, immunohistochemistry, in situ hybridization, electron microscopy, 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. The company 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: In the support of non-clinical drug safety testing and new chemical development, the company’s 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, the company’s 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 in the support of non-clinical studies, the company also supports the clinical bioanalysis required in clinical trials for drug development. In addition, the company’s Laboratory Sciences group is able to measure a wide range of nonclinical 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 requirements and GLP to the extent required by the FDA, Environmental Protection Agency, the United States Department of Agriculture (USDA), 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, the company’s early-stage discovery work, which is not subject to GLP regulations, is typically carried out under a quality management system. The company’s Safety Assessment facilities and Manufacturing facilities are regularly inspected by the U.S. and other regulatory compliance monitoring authorities, the company’s clients’ quality assurance departments and the company’s own internal quality audit program. Manufacturing Solutions The company’s Manufacturing Solutions segment is consisted of 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 the company’s 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. The company’s 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. The company’s 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 the company’s 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 as of December 31, 2023. 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 the company collects to limit its impact on the horseshoe crab population. 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 the company’s 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 the company’s rapid cartridge technology and are seeking to meet data integrity requirements with the company’s automated systems and software solutions. The company recently launched Endosafe Trillium, the company’s new 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 the company’s 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. The company 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 ten global labs, Accugenix excels in providing accurate and timely microbial identification services and products required to meet internal quality standards and government regulations. Accugenix also offers an in- house solution with the company’s Axcess instrument that allows clients to perform identification testing in their own lab with access to the company’s proprietary library. Biologics Solutions: The company’s Biologics Solutions (Biologics) business is consisted of its Biologics Testing Services business and CDMO business. Biologics 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 the company’s 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. The company further designs and provides viral clearance programs according to GLP at its German facility and cGMP at the company’s U.S. facility for Phase I, II and III human clinical studies, as well as for market authorization. Biologics Testing Services The company’s Biologics Testing Services business encompasses process development and quality-control testing to support the manufacture of biologics. The company performs specialized testing of biologics frequently outsourced by pharmaceutical and biotechnology companies globally and is a partner in navigating the complex pathway to biologic effectiveness. The company’s 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 the company’s clients to obtain new drug approvals, to maintain government-licensed manufacturing facilities and to manufacture and release market-approved therapeutic products for patient treatment. To meet growing demand, the company continues to expand its Biologics Testing Solutions service offerings and facilities in the U.S. and Europe. The company 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. The company’s 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 the company as a premier scientific partner for cell and gene therapy development, testing, and manufacturing. The full integrated advanced therapeutics portfolio enables the company 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 the company’s 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 the company’s 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. The company’s strategies include 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 has expanded its service capabilities into the high-growth, high-science sector of cell and gene therapy. Acquisitions, such as the company’s acquisitions of Distributed Bio, Retrogenix, Cognate, and Vigene in 2021; Explora BioLabs in 2022; and SAMDI and Noveprim in 2023, are an integral part of the company’s growth strategy, both to expand its portfolio and broaden the company’s geographic footprint. The company’s long-term strategy also includes growth through establishing relationships and exploring other opportunities and areas that have the potential to strengthen the company’s broad-based portfolio of products and services. In particular, the company’s focus has been to drive differentiation through technologies that enhance the speed to develop a clinical candidate and allow biopharmaceutical companies to make earlier go/no-go decisions. 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 primarily consist of major biopharmaceutical companies; many 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 and government agencies. Sales, Marketing and Customer Support In addition to the company’s field sales teams and related specialists, the company has a team of alliance managers who are organized by key client within the company’s market segments (global biopharmaceutical, small and mid-sized pharmaceutical and biotechnology companies, and academic and government institutions). This enhances the company’s ability to meet client needs by offering customized, tailored solutions across the company’s 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. The company also applies the use of dedicated sales specialists for certain technical product lines, such as in the company’s 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, the company’s 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, the company’s direct sales force is supplemented by international distributors and agents. Regulatory Matters The company complies with licensing and registration requirement standards set by the USDA and the 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. The company’s 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 organization that promotes the humane treatment of animals in science and education through voluntary accreditation and assessment programs. GLP compliance is required by such regulatory agencies as the 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. The company 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 the company manufactures products or performs testing in a prescribed manner with respect to cGMP compliance, and maintains records of the company’s manufacturing, testing and control activities. History Charles River Laboratories International, Inc. was founded in 1947. The company was incorporated in 1994.