A major contributor to this article appears to have a close connection with its subject.(October 2021) |
Industry |
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Founded | September 2015 |
Headquarters | Indianapolis, IN, United States; facilities in 14+ countries |
Key people | |
Services |
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Number of employees | 1,200+ (2020) |
Parent | Inotiv (2021–present) |
Envigo (en-VEE-go) is a privately held contract research organization and laboratory animal sourcer that provides live animals and related products and services to pharmaceutical and biotechnology industries, government, academia and other life science organizations engaged in animal testing. [2] The company breeds and sells research animals – which are referred to in the industry as "research models"– including rodents (mice, rats, hamsters and guinea pigs), rabbits, beagles and non-human primates. [3] Envigo is headquartered in Indianapolis, Indiana and employs more than 1,200 people at 30+ locations across North America, Europe and the Middle East. [4] [ failed verification ]
Many of Envigo's breeding sites have been accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International Council including: Horst, the Netherlands (March 29, 2016), [5] Indianapolis, IN, Livermore, CA, Boyertown and Denver, PA, St Louis, MO and others. [6] [2] However, the U.S. Department of Agriculture (USDA) found multiple violations of the Animal Welfare Act at the company's Cumberland, Virginia dog-breeding facility and the U.S. Department of Justice filed a complaint against Envigo for the violations in federal court. [7] In a settlement reached in July 2022, the company agreed to no longer engage in activities at the site that require an Animal Welfare Act license and to relinquish the over 4,000 beagles at the facility to the Humane Society of the United States. [7]
Envigo was created in September 2015 when Huntingdon Life Sciences, Harlan Laboratories and three subsidiaries (GFA, NDA Analytics and LSR Associates) merged. The combined organization had 3,800 employees at inception with sales approaching $500 million. [8] The company's rebranded name, Envigo, supposedly incorporated the English words enhance, enrich and vigorous. [9] The Latin root of the word vigorous is “vita” meaning “life.”
The company consists of two core business units: Contract Research Services (CRS) and Research Models and Services (RMS). The CRS business unit offers a range of drug development and environmental sciences services, including safety assessment, analytical, metabolism, CMC and regulatory consultancy from nine contract research facilities located in Europe, the United States and Middle East. The RMS business unit provides research models (live animals), lab animal diets and bedding and support services from 30 sites worldwide. [10]
Envigo acquired LabCorp's Covance Research Products business in June 2019, while LabCorp's Covance Drug Development segment acquired Envigo's nonclinical contract research services business. Both companies continue to collaborate through a multi-year, renewable supply agreement. [11] In December 2019, Envigo acquired Horizon Discovery's research models business unit which provides genetically engineered models from its Boyertown, Pennsylvania and St. Louis, Missouri locations. The business unit uses gene editing expertise to produce customized models with clinically relevant gene deletions, insertions and other modifications which are then used as preclinical models for human disease during drug discovery and development. The two companies announced collaboration to ensure continuity and enable all customers to access CRISPR-edited research models for screening and other applications. [12]
Envigo RMS Holding Corp. was acquired by Inotiv in November 2021. [13] In July 2022, a shareholder filed a class action lawsuit against Inotiv for failing to disclose the effect the Envigo acquisition would have on Inotiv's earnings. [14]
Envigo owned and operated a research and breeding facility in Cumberland, Virginia that housed over 5,000 beagles, bred and sold for medical research. In 2019, PETA conducted an undercover investigation at Envigo's Cumberland facility. The investigation led to a PETA campaign calling for the USDA and other Envigo customers to cut ties with the company. [15] After a routine inspection in July 2021, USDA inspectors cited Envigo for 26 violations of the Animal Welfare Act. [16] Inspectors again cited Envigo for 13 violations, including 11 repeat violations, on a repeat inspection in October 2021. [17] Inspectors noted in their reports that more than 500 dogs were experiencing pain and discomfort, being left in 85-degree heat without air conditioning for up to five hours, and infrequent cleaning left kennels and feeders hounded by insects. More than a dozen dogs were found to have paw and eye injuries, as well as some with “severe dental disease.” In addition, the USDA noted that over a seven-month period, more than 300 puppies died from “unknown causes,” and the facility had kept unfinished records regarding their deaths. [18] As a result of these reports and undercover investigations by local news WRIC-TV and PETA, multiple state legislators in Virginia introduced new legislation that would tighten regulation and subject employees to criminal liability. [19] [20] [21]
After a repeat inspection on March 8, 2022, found five repeat violations, including unsafe conditions, animal injuries, and mold and feces in the food supply, Virginia Senators Mark Warner and Tim Kaine sent a letter to the USDA requesting that the facility's license be temporarily revoked. In a comment regarding the letter, Senator Warner said, "We’ve seen these horrific incidents … it needs to be shut down...Not only do we want the Cumberland facility to be closed on a temporary basis to make sure that we don’t see these violations, but we want to make sure there is a thorough review of Envigo’s facilities elsewhere around the country.” [22]
The U.S. Department of Justice filed a complaint against Envigo in federal district court on May 19, 2022, seeking an injunction to stop Envigo from breeding, selling, or otherwise dealing in beagles at its Cumberland, Virginia, facility. The complaint recited the long-term serious violations of federal law by Envigo and hundreds of deaths of animals at their hands, often occurring in brutal circumstances. [23] The government also seized nearly 150 beagles from the site that were in desperate need of medical treatment denied by Envigo. [24]
U.S. District Court Judge Norman Moon issued an emergency order imposing a series of restrictions on Envigo. [25] Judge Moon said the evidence from federal inspections of the Envigo puppy factory shows that more than 300 beagle puppies have died there over the last seven months of unknown causes. He also said in his order that nursing beagles were denied adequate food, and puppies were euthanized without anesthesia. [26]
“[T]he Government’s veterinarians continue to examine dogs throughout the weekend” there, and the number of dogs seized “is likely to grow,” according to the ruling. Beagles have been found with “significant and serious health conditions, including wounds … swollen or enflamed paws, or … dental disease” and “many more beagles still face inadequate food and water, veterinary care, and the other torturous conditions described.” This week, “investigators observed ‘widespread fighting’ between beagles sharing food sources ... [and] beagles fighting between adjacent cages.” According to the court, “In multiple enclosures, puppies were unable to access the spigots to get water on their own, and when the investigator ‘held down the spigot to release water,’ the puppies ‘immediately rushed to the spigot to get water and drank heavily and quickly.’" [26] Investigators also found numerous beagles trapped in cage floors, one whose jaw was stuck in the cage bars, and unhygienic conditions including insects, mold and a buildup of old food. [27]
“[T]he Government has provided sufficient evidence that Envigo is engaged in serious and ongoing violations of the Animal Welfare Act, and that an immediate temporary restraining order must issue to put a halt to such violations pending further proceedings,” Judge Moon wrote. [26]
In June 2024, Envigo resolved the two-year investigation by the Department of Justice by pleading guilty to conspiring to violate the Animal Welfare Act and conspiring to violate the Clean Water Act, agreeing to pay $22 million in fines, including the largest-ever fine imposed by the Department of Justice in an animal welfare case, as well as agreeing to pay an additional $13.5 million toward animal welfare and environmental projects, law enforcement expenses, and improvements to Envigo's facilities. Lawsuits and Federal investigations stemming from alleged illegal smuggling of monkeys from Cambodia, and misleading shareholders on the origins and sources of their primate research models (claiming all animals were purpose bred when in fact many were wild-caught), remain active. [28]
In a settlement reached in July 2022, Envigo agreed to no longer engage in activities at the Cumberland site that require an Animal Welfare Act license and to relinquish the nearly 4,000 beagles at the facility to the Humane Society of the United States. [7] The company was also ordered to pay a portion of the adoptions costs. [29] The remainder of the costs were covered by dog rescue charities. [30] This represents the largest animal welfare seizure in the Humane Society's 67-year history. [31] The Humane Society transported the dogs to a network of shelters across the United States and by September 1, 2022, all of the dogs had been adopted. [32] One of the beagles rescued from Envigo, a six-year-old female named Momma Mia, was adopted by Meghan, the Duchess of Sussex and Prince Harry. [33] Another rescued puppy named Morty was adopted by New Jersey Governor Phil Murphy and is now the First Dog of New Jersey. [34]
In June 2024, Envigo pleaded guilty to federal animal welfare and environmental crimes and agreed to pay $22 million in fines plus $13.5 million to support animal welfare and environmental projects, cover law enforcement expenses and improve its own facilities. [35]
This section contains close paraphrasing of a non-free copyrighted source, https://www.envigo.com/research-services ( Copyvios report ).(April 2022) |
Collections of biological products from laboratory animals are raised under closely defined conditions to protect research and research animals. Models are regularly monitored and fed controlled, natural-ingredient diets to minimize lot-to-lot variation. [36]
Customer research programs require plan development and execution — which may include cryopreservation (embryo and sperm), genotyping and zygosity, rederivation (speed rederivation), revitalization and speed congenics. [37] [ circular reference ]
A multi-phased process producing monoclonal or polyclonal antibodies to enhance customer research, diagnostic or therapeutic applications. Tailored programs use the in vivo approach, in vitro production method and hybridoma development to enhance customer research, diagnostic or therapeutic applications which include ancillary services like downstream antibody and purification processes. [38]
A quality assurance system to assess, design, test, report, interpret and support facility managers in the maintenance of healthy, laboratory animal populations critical to research integrity. The microbiological quality of animal models may influence animal welfare and the validity and reproducibility of research data. Microbiologists, (molecular) biologists and veterinarians perform these health surveillance services, optimally, in diagnostic laboratories certified by the International Organization for Standardization (ISO). [39]
This includes genotyping, zygosity testing, gene expression analysis, high-throughput screening services, large-scale single nucleotide polymorphism analysis, sequencing services and storage. [40]
Customization of rodent model genetics to customer specifications through gene deletion, insertion and other modifications. GEMS provides pre-developed transgenic rodent models (gene knock-in or gene knockout) and support custom breeding, cryopreservation and recovery and rapid colony expansion. [41]
Studies with emphasis on animal-based research continue to trend toward research model diversity, functional genomics, gene therapy, cancer biology, aging, infectious disease, neurobiology and more. Products include, but are not limited to, aged models, ocular-ready models and pre-conditioned models (husbandry and diet specific). Services include contract breeding and maintenance, social housing solutions, cryopreservation (embryo and sperm), genotyping and zygosity, rederivation (speed rederivation), revitalization and speed congenics. [42]
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Envigo's Teklad business unit provides both high-fat and control diets mostly used in research on the impact of obesity and nutrition on disease states like diabetes, cancer and heart disease. [43]
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Tumor models and studies using cell line-derived xenografts (CDX) and highly characterized patient derived xenografts (PDX) for breast cancer and melanoma. Studies may also include different strains, ovariectomized models and untreated tumors. Clients may receive weekly updates and end of study samples for final report supplementation with syngeneic, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) studies.
People for the Ethical Treatment of Animals is an American animal rights nonprofit organization based in Norfolk, Virginia, and led by Ingrid Newkirk, its international president. PETA says that its entities have more than 9 million members globally.
The American Society for the Prevention of Cruelty to Animals (ASPCA) is a non-profit organization dedicated to preventing animal cruelty. Based in New York City since its inception in 1866, the organization's mission is "to provide effective means for the prevention of cruelty to animals throughout the United States."
A puppy mill, also known as a puppy farm, is a commercial dog breeding facility characterized by quick breeding and poor conditions. Although no standardized legal definition for "puppy mill" exists, a definition was established in Avenson v. Zegart in 1984 as "a dog breeding operation in which the health of the mill’s dogs is disregarded to maintain a low overhead and maximize profits". They are cited as being a result of increased demand for household pets, especially after World War II. The Veterinary Medical Association of the Humane Society of the United States defines the main characteristics of a puppy mill as "emphasis on quantity over quality, indiscriminate breeding, continuous confinement, lack of human contact and environmental enrichment, poor husbandry, and minimal to no veterinary care."
Huntingdon Life Sciences (HLS) was a contract research organisation (CRO) founded in 1951 in Cambridgeshire, England. It had two laboratories in the United Kingdom and one in the United States. With over 1,600 staff, it was until 2015 the largest non-clinical CRO in Europe. In September 2015, Huntingdon Life Sciences, Harlan Laboratories, GFA, NDA Analytics and LSR associates merged into Envigo, which later sold off the CRO part.
The Animal and Plant Health Inspection Service (APHIS) is an agency of the United States Department of Agriculture (USDA) based in Riverdale, Maryland responsible for protecting animal health, animal welfare, and plant health. APHIS is the lead agency for collaboration with other agencies to protect U.S. agriculture from invasive pests and diseases. APHIS's PPQ is the National Plant Protection Organization for the U.S., and the agency's head of veterinary services/veterinary Deputy Administrator is the Chief Veterinary Officer of the United States.
Labcorp Drug Development presently known as Fortrea is a contract research organization headquartered in Burlington, North Carolina, providing nonclinical, preclinical, clinical and commercialization services to pharmaceutical and biotechnology industries. Formerly called Covance, the company is spin-off from Labcorp, which employs more than 70,000 people worldwide.
The Animal Welfare Act was signed into law by President Lyndon B. Johnson on August 24, 1966. It is the main federal law in the United States that regulates the treatment of animals in research and exhibition. Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act as the minimally acceptable standard for animal treatment and care. The USDA and APHIS oversee the AWA and the House and Senate Agriculture Committees have primary legislative jurisdiction over the Act. Animals covered under this Act include any live or dead cat, dog, hamster, rabbit, nonhuman primate, guinea pig, and any other warm-blooded animal determined by the Secretary of Agriculture for research, pet use or exhibition. Excluded from the Act are birds, rats of the genus Rattus, mice of the genus Mus, farm animals, and all cold-blooded animals.
Charles River Laboratories International, Inc., is an American pharmaceutical company specializing in a variety of preclinical and clinical laboratory, gene therapy and cell therapy services for the pharmaceutical, medical device and biotechnology industries. It also supplies assorted biomedical products, outsourcing services, and animals for research and development in the pharmaceutical industry and offers support in the fields of basic research, drug discovery, safety and efficacy, clinical support, and manufacturing.
The Center for Elephant Conservation (CEC) is a 200-acre (0.81 km2) breeding farm and retirement facility for elephants in Polk City, Florida, opened in 1995. The CEC is solely sponsored by Feld Entertainment, the holding company which operated the Ringling Bros. and Barnum & Bailey Circus from the 1960s until 2017.
Institutional Animal Care and Use Committees (IACUCs) are centrally important in applying laws about animal research in the United States. Similar systems operate in other countries, but generally under different titles; for example, in Canada a typical title would be the University Animal Care Committee (UACC), while in the United Kingdom it would be the Animal Welfare and Ethical Review Body (AWERB).
Texas Biomedical Research Institute, located in San Antonio, Texas, is an independent, non-profit biomedical research institution, specializing in genetics and in virology and immunology. Texas Biomed is funded by government and corporate grants and contracts, and donations from the public.
Animals used by laboratories for testing purposes are largely supplied by dealers who specialize in selling them to universities, medical and veterinary schools, and companies that provide contract animal-testing services. It is comparatively rare that animals are procured from sources other than specialized dealers, as this poses the threat of introducing disease into a colony and confounding any data collected. However, suppliers of laboratory animals may include breeders who supply purpose-bred animals, businesses that trade in wild animals, and dealers who supply animals sourced from pounds, auctions, and newspaper ads. Animal shelters may also supply the laboratories directly. Some animal dealers, termed Class B dealers, have been reported to engage in kidnapping pets from residences or illegally trapping strays, a practice dubbed as bunching.
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Patti Strand is the founder of the National Animal Interest Alliance (NAIA), a broad-based, mainstream, nonprofit animal welfare organization dedicated to encouraging high standards of animal care and treatment, and to preserving the human animal bond. She is an author of books and articles and has served on numerous local, state and federal animal welfare advisory boards, committees and task force bodies.
Animal welfare in the United States relates to the treatment of non-human animals in fields such as agriculture, hunting, medical testing and the domestic ownership of animals. It is distinct from animal conservation.
The Washington National Primate Research Center (WaNPRC) is a federally-funded biomedical research facility located on the Seattle campus of the University of Washington. The WaNPRC is one of seven National Primate Research Centers established by the National Institutes of Health in the 1960s The Washington primate center opened in 1961 and as of 2020, housed over 900 primates. The center is affiliated with the University of Washington Schools of Medicine, Public Health, affiliated research centers and the University of Washington Medical Center. It employs over 150 scientists and staff.
The University of Washington practices animal testing for a variety of purposes, including biomedical testing and paramedic training. Testing is performed by faculty from various departments across the university, and is conducted on animals including dogs, rabbits, primates, pigs, sheep, gerbils, bobcats, ferrets, and coyotes. Testing on primates is done through the Washington National Primate Research Center, which is located on campus. Animal testing at UW is overseen by the university's Institutional Animal Care and Use Committee (IACUC).
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The government is requesting that a judge declare Envigo has repeatedly violated the Animal Welfare Act and restrain the company from further violations. 'Envigo is failing to meet the minimum standards for handling and housing the beagles, resulting in the unnecessary suffering and, at times, death of beagles at the Cumberland Facility,' the complaint said.