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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 Phase I vaccine candidates under 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 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 beginning to end or any individual function listed above under GMP conditions. The facility also has the capability to ... [...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 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 for the DoD and th ... [...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 through drug manufacturing. This allows major pharmaceutical companies to 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-formulation, * formulation development, * stability studies, * method development, * pre-clinical and Phase I clinical trial materials, * late-stage clinical trial materials, * formal stability, * scale-up, * registration batches and commercial production. C ... [...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 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 recognize further 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 alleviate 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). Some vaccines offer full sterilizing immunity, in which infection is prevented. T ... [...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 drug 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. Description 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. When expressed specifically, a clinical trial phase is capitalized both in name and Roman numeral, such as "Phase I" clinical trial. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory aut ... [...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 manageme ... [...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 area, unincorporated, it is an edge city with a population of 81,015 at the 2020 United States census, 2020 census, making it the fifth-most-populous place in Maryland after Baltimore, Columbia, Maryland, Columbia, Germantown, Maryland, Germantown, and Waldorf, Maryland, Waldorf. Downtown Silver Spring, located next to the northern tip of Washington, D.C., is the oldest and most Urbanization, urbanized area of Silver Spring, 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 area's surrounding land. Acorn Park, south of downtown, is be ... [...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 ... [...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). However, 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 other factors like regulating lasers, cellular phones, and condoms. In addition, the FDA takes control of disea ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Zika Virus
Zika virus (ZIKV; pronounced or ) is a member of the virus family ''Flaviviridae''. It is spread by daytime-active ''Aedes'' mosquitoes, such as '' A. aegypti'' and '' A. albopictus''. Its name comes from the Ziika Forest of Uganda, where the virus was first isolated in 1947. Zika virus shares a genus with the dengue, yellow fever, Japanese encephalitis, and West Nile viruses. Since the 1950s, it has been known to occur within a narrow equatorial belt from Africa to Asia. From 2007 to , the virus spread eastward, across the Pacific Ocean to the Americas, leading to the 2015–2016 Zika virus epidemic. The infection, known as Zika fever or Zika virus disease, often causes no or only mild symptoms, similar to a very mild form of dengue fever. While there is no specific treatment, paracetamol (acetaminophen) and rest may help with the symptoms. Zika can spread from a pregnant woman to her baby. This can result in microcephaly, severe brain malformations, and other b ... [...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. The 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 fundi ... [...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. The 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 illness, often resulting only in the production of antibodies in the blood. If transmission causes human illness, it is called a zoonotic swine flu. People with regular exposure to pigs are at increased risk of swine flu infections. Around the mid-20th century, the identification of influenza subtypes was made possible, allowing accurate diagnosis of transmission to humans. Since then, only 50 such transmissions have been confirmed. These strai ... [...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, walls and windows, usually standing permanently in one place, such as a house or factory. Buildings come in a variety of sizes, shapes, and functions, and have been adapted throughout history for numerous factors, from building materials available, to weather conditions, land prices, ground conditions, specific uses, prestige, and aesthetic reasons. To better understand the concept, see ''Nonbuilding structure'' for contrast. Buildings serve several societal needs – occupancy, 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 separation of the human habitat (a place of comfort and safety) from the ''outside'' (a place that may be harsh and harmful at times). buildings have been objects or canvasses of much artistic expression. In recent years, interest in sustainable planning and building pract ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
