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Pilot Bioproduction Facility
The Pilot Bioproduction Facility of the Walter Reed Army Institute of Research (WRAIR) is a Contract Manufacturing Organization (CMO) facility whose mission is to perform vaccine production on a pilot scale. The facility produces pre-license Phases_of_clinical_research#Phase_I, Phase I vaccine candidates under Good manufacturing practice, cGMP conditions using both bacterial and viral based technology. It is located at the Forest Glen Annex of the Walter Reed Army Institute of Research in Silver Spring, Maryland. Its business methodology is to work with government agencies through interagency agreements and with private companies through CRADAs (Cooperative Research and Development Agreement, Cooperative Research and Development Agreements) in order to produce vaccine candidates. Its manufacturing capabilities include bacterial and viral seed banking, fermentation, purification (bacterial and viral proteins), and aseptic filling. The facility can perform whole campaigns from beginn ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Walter Reed Army Institute Of Research
The Walter Reed Army Institute of Research (WRAIR) is the largest biomedical research facility administered by the U.S. Department of Defense (DoD). The institute is centered at the Forest Glen Annex, in the Forest Glen Park part of the unincorporated Silver Spring urban area in Maryland just north of Washington, DC, but it is a subordinate unit of the U.S. Army Medical Research and Development Command (USAMRDC), headquartered at nearby Fort Detrick, Maryland. At Forest Glen, the WRAIR has shared a laboratory and administrative facility — the Sen Daniel K. Inouye Building, also known as Building 503 — with the Naval Medical Research Center since 1999. The Institute takes its name from Major (United States), Major Walter Reed, MD (1851–1902), the Army physician who, in 1901, led the team that confirmed the theory that yellow fever is transmitted by a particular mosquito species, rather than by direct contact. Today, the WRAIR fosters and performs biomedical research ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Contract Manufacturing Organization
A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organization in the pharma industry, is a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive services from drug development Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for re ... through drug manufacturing. This allows major pharmaceutical companies to outsourcing, outsource those aspects of the business, which can help with scalability or can allow the major company to focus on drug discovery and drug marketing instead. Services offered by CDMOs include, but are not limited to: pre-formul ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Vaccine
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verified. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or Antigen, killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and to further recognize and destroy any of the microorganisms associated with that agent that it may encounter in the future. Vaccines can be prophylaxis, prophylactic (to prevent or ameliorate the effects of a future infection by a natural or "wild" pathogen), or therapeutic vaccines, therapeutic (to fight a disease that has already occurred, such as cancer vaccine, cancer). [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Phases Of Clinical Research
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays. Summary Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over sever ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Good Manufacturing Practice
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality managemen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Silver Spring, Maryland
Silver Spring is a census-designated place (CDP) in southeastern Montgomery County, Maryland, United States, near Washington, D.C. Although officially unincorporated, in practice it is an edge city, with a population of 81,015 at the 2020 census, making it the fifth-most populous place in Maryland after Baltimore, Columbia, Germantown, and Waldorf. Downtown, next to the northern tip of Washington, D.C., is the oldest and most urbanized part of the community, surrounded by several inner suburban residential neighborhoods inside the Capital Beltway. Many mixed-use developments combining retail, residential, and office space have been built since 2004. Silver Spring takes its name from a mica-flecked spring discovered there in 1840 by Francis Preston Blair, who subsequently bought much of the surrounding land. Acorn Park, south of downtown, is believed to be the site of the original spring. Geography As an unincorporated CDP, Silver Spring's boundaries are not consistently de ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cooperative Research And Development Agreement
In the United States, a cooperative research and development agreement (CRADA or CRDA) is an agreement between a government agency and another government agency, a private company, non-profit, or university to work together on research and development. Description Designated under the Federal Technology Transfer Act of 1986 (P.L. 99-502) (which amended the Stevenson-Wydler Technology Innovation Act of 1980 (P.L. 96-480)), a CRADA is intended to speed the commercialization of technology, optimize resources, and protect the private company involved. A CRADA allows both parties to keep research results confidential for up to five years under the Freedom of Information Act. The Office of Scientific and Technical Information (OSTI) is responsible for preserving the scientific and technical information generated through a CRADA and making this information readily available to the scientific community as well as the public. Private corporations participating in a CRADA are allowed to f ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration (United States)
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying fro ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Women's Interagency HIV Study
The Women's Interagency HIV Study (WIHS) was established in August 1993 to investigate the impact and progression of HIV disease in women. he WIHS enrolls both HIV-positive and HIV-negative women. The core portion of the study includes a detailed and structured interview, physical and gynecologic examination, and laboratory testing. The WIHS participants are also asked to enroll in various sub-studies, such as cardiovascular, metabolic, musculoskeletal, and neurocognition. New proposals for WIHS sub-studies are submitted for approval by various scientific investigators from around the world. Funding The WIHS is funded primarily by the National Institute of Allergy and Infectious Diseases (NIAID), with additional co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Cancer Institute (NCI), the National Institute on Drug Abuse (NIDA), and the National Institute on Mental Health (NIMH). Targeted supplemental fundin ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Swine Flu
Swine influenza is an infection caused by any of several types of swine influenza viruses. Swine influenza virus (SIV) or swine-origin influenza virus (S-OIV) refers to any strain of the influenza family of viruses that is endemic in pigs. As of 2009, identified SIV strains include influenza C and the subtypes of influenza A known as H1N1, H1N2, H2N1, H3N1, H3N2, and H2N3. Swine influenza virus is common throughout pig populations worldwide. Transmission of the virus from pigs to humans is rare, and does not always lead to human flu, often resulting only in the production of antibodies in the blood. If transmission causes human flu, it is called zoonotic swine flu. People with regular exposure to pigs are at increased risk of swine flu infections. Around the mid-20th century, identification of influenza subtypes was made possible, allowing accurate diagnosis of transmission to humans. Since then, only 50 such transmissions have been confirmed. These strains of swine flu rarel ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Buildings And Structures In Silver Spring, Maryland
A building, or edifice, is an enclosed structure with a roof and walls standing more or less permanently in one place, such as a house or factory (although there's also portable buildings). Buildings come in a variety of sizes, shapes, and functions, and have been adapted throughout history for a wide number of factors, from building materials available, to weather conditions, land prices, ground conditions, specific uses, prestige, and aesthetic reasons. To better understand the term ''building'' compare the list of nonbuilding structures. Buildings serve several societal needs – primarily as shelter from weather, security, living space, privacy, to store belongings, and to comfortably live and work. A building as a shelter represents a physical division of the human habitat (a place of comfort and safety) and the ''outside'' (a place that at times may be harsh and harmful). Ever since the first cave paintings, buildings have also become objects or canvasses of much artistic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Forest Glen Annex
The Forest Glen Annex is a U.S. Army installation in the Forest Glen Park neighborhood of Silver Spring, Maryland, USA. It is situated between Brookville Road and Linden Lane. Since 1999, the Annex has been the site of the Walter Reed Army Institute of Research (WRAIR) and the Naval Medical Research Center (NMRC), along with smaller units. The Forest Glen property was acquired by the Army during the World War II era, and was formerly known as the “Walter Reed Forest Glen Annex”, a branch of the Walter Reed Army Medical Center (WRAMC) in Washington, DC. Facilities In addition to the large research laboratories located in the Annex's " Daniel K. Inouye Building" (Building 503), the post includes a commissary, a child care center, and a Fisher House. There are also football and baseball fields, and picnicking facilities. The Forest Glen Annex campus includes the National Park Seminary Historic District which is being redeveloped separately from the military area. The ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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