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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. CDMOs are contract manufactur ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Company
A company, abbreviated as co., is a legal entity representing an association of people, whether natural, legal or a mixture of both, with a specific objective. Company members share a common purpose and unite to achieve specific, declared goals. Companies take various forms, such as: * voluntary associations, which may include nonprofit organizations * business entities, whose aim is generating profit * financial entities and banks * programs or educational institutions A company can be created as a legal person so that the company itself has limited liability as members perform or fail to discharge their duty according to the publicly declared incorporation, or published policy. When a company closes, it may need to be liquidated to avoid further legal obligations. Companies may associate and collectively register themselves as new companies; the resulting entities are often known as corporate groups. Meanings and definitions A company can be defined as an "arti ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Mergers And Acquisitions
Mergers and acquisitions (M&A) are business transactions in which the ownership of Company, companies, other business organizations, or their operating units are transferred to or Consolidation (business), consolidated with another company or business organization. As an aspect of strategic management, M&A can allow enterprises to grow or Layoff, downsize, and change the nature of their business or competitive position. Technically, a is a legal consolidation of two business entities into one, whereas an occurs when one entity takes ownership of another entity's share capital, equity (finance), equity interests or assets. A deal may be euphemism, euphemistically called a ''merger of equals'' if both Chief executive officer, CEOs agree that joining together is in the best interest of both of their companies. From a legal and financial point of view, both mergers and acquisitions generally result in the consolidation of assets and Liability (financial accounting), liabilities un ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Data Security
Data security means protecting digital data, such as those in a database, from destructive forces and from the unwanted actions of unauthorized users, such as a cyberattack or a data breach. Technologies Disk encryption Disk encryption refers to encryption technology that encrypts data on a hard disk drive. Disk encryption typically takes form in either software (see disk encryption software) or hardware (see disk encryption hardware). Disk encryption is often referred to as on-the-fly encryption (OTFE) or transparent encryption. Software versus hardware-based mechanisms for protecting data Software-based security solutions encrypt the data to protect it from theft. However, a malicious program or a hacker could corrupt the data to make it unrecoverable, making the system unusable. Hardware-based security solutions prevent read and write access to data, which provides very strong protection against tampering and unauthorized access. Hardware-based security or as ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality (business)
In business, engineering, and manufacturing, quality – or high quality – has a pragmatic interpretation as the non-inferiority or wikt:superiority, superiority of something (goods or service (economics), services); it is also defined as being suitable for the intended purpose (fitness for purpose) while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjectivity, subjective attribute and may be understood differently by different people. Consumers may focus on the Acceptance testing, specification quality of a product/service, or how it compares to competitors in the marketplace. Producers might measure the Conformance testing, conformance quality, or degree to which the product/service was produced correctly. Support personnel may measure quality in the degree that a product is wikt:reliable, reliable, Maintainability, maintainable, or sustainability, sustainable. In such ways, the subjectivity of quality is rendered objectivity (philosoph ... [...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] |
Samsung Biologics
Samsung Biologics is a South Korean biotechnology company headquartered in Songdo, Incheon, South Korea. The biotech division of Samsung Group, it provides contract development and manufacturing (CDMO) services to the biopharmaceutical industry. The company has partnered with GlaxoSmithKline, Eli Lilly and AstraZeneca for COVID-19 treatments. Samsung Biologics also partnered with Moderna for fill-finish, packaging and labeling of its mRNA vaccine, Spikevax, and Greenlight Biosciences on the manufacturing of mRNA vaccine drug substance candidate during the COVID-19 pandemic. History Founded in 2011, Samsung Biologics built three manufacturing plants with a capacity of more than 360,000 liters, from 2011 to 2018, making it the world's largest contract-based manufacturer in the biopharmaceutical sector at a single site as of 2018. Since 2020, Samsung Biologics has operated a research and development center in San Francisco, California. In 2012, it established Samsung Bioepis, a bi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 U.S. state, states, a Washington, D.C., federal district, five major unincorporated territories, nine United States Minor Outlying Islands, Minor Outlying Islands, and 326 Indian reservations. The United States is also in Compact of Free Association, free association with three Oceania, Pacific Island Sovereign state, sovereign states: the Federated States of Micronesia, the Marshall Islands, and the Palau, Republic of Palau. It is the world's List of countries and dependencies by area, third-largest country by both land and total area. It shares land borders Canada–United States border, with Canada to its north and Mexico–United States border, with Mexico to its south and has maritime borders with the Bahamas, Cuba, Russia, and other nations. With a population of over 333 million, it is the List of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
South Carolina
)'' Animis opibusque parati'' ( for, , Latin, Prepared in mind and resources, links=no) , anthem = "Carolina";" South Carolina On My Mind" , Former = Province of South Carolina , seat = Columbia , LargestCity = Charleston , LargestMetro = Greenville (combined and metro)Columbia (urban) , BorderingStates = Georgia, North Carolina , OfficialLang = English , population_demonym = List of U.S. state residents names, South Carolinian , Governor = , Lieutenant Governor = , Legislature = South Carolina General Assembly, General Assembly , Upperhouse = South Carolina Senate, Senate , Lowerhouse = South Carolina House of Representatives, House of Representatives , Judiciary = South Carolina Supreme Court , Senators = , Representative = 6 Republicans1 Democrat , postal_code = SC , TradAbbreviation = S.C. , area_rank = 40th , area_total_sq_mi = 32,020 , area_total_km2 = 82,932 , area_land_sq_mi = 30,109 , area_land_km2 = 77,982 , area_water_sq_mi = 1,911 , area_wat ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
GlaxoSmithKline
GSK plc, formerly GlaxoSmithKline plc, is a British Multinational corporation, multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a Mergers and acquisitions, merger of Glaxo Wellcome and SmithKline Beecham. GSK is the tenth largest pharmaceutical company and #294 on the 2022 Fortune Global 500, ''Fortune'' Global 500, ranked behind other pharmaceutical companies China Resources, Sinopharm (company), Sinopharm, Johnson & Johnson, Pfizer, Roche, AbbVie, Novartis, Bayer, and Merck Group, Merck. The company has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index. , it had a market capitalisation of £70 billion, the eighth largest on the London Stock Exchange. It has a secondary listing on the New York Stock Exchange. The company developed the first malaria vaccine, RTS,S, which it said in 2014 it would make available for five percent above cost. Legacy products develope ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Boucherville
Boucherville is a city in the Montérégie region in Quebec, Canada. It is a suburb of Montreal on the South shore of the Saint Lawrence River. Boucherville is part of both the urban agglomeration of Longueuil and Montreal Metropolitan Community regional government. History Early history Boucherville was founded as a seigneurial parish in 1667 by Pierre Boucher, for whom the city was later named. Pierre Boucher came from Mortagne-au-Perche, Normandy, France. After having lived in Quebec City and Trois-Rivières, Boucher moved to the Percées Islands by the southern shores of Saint Lawrence River, where he founded Boucherville. The first Catholic church of the village of Boucherville was built in 1670. This church, made of wood, was eventually replaced in 1712 by a building made of brick. It was replaced in 1801 by the current Sainte-Famille Church. Several families left Boucherville in the 18th century to found the communities of Sainte-Julie and Saint-Bruno-de-Montarville. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Novartis
Novartis AG is a Swiss-American multinational pharmaceutical corporation based in Basel, Switzerland and Cambridge, Massachusetts, United States (global research).name="novartis.com">https://www.novartis.com/research-development/research-locations It is one of the largest pharmaceutical companies in the world. Novartis manufactures the drugs clozapine (Clozaril), diclofenac (Voltaren; sold to GlaxoSmithKline in 2015 deal), carbamazepine (Tegretol), valsartan (Diovan), imatinib mesylate (Gleevec/Glivec), cyclosporine (Neoral/Sandimmune), letrozole (Femara), methylphenidate (Ritalin; production ceased 2020), terbinafine (Lamisil), deferasirox (Exjade), and others. In March 1996, the companies Ciba-Geigy and Sandoz merged to form Novartis; the pharmaceutical and agrochemical divisions of both companies formed Novartis as an independent entity. Other Ciba-Geigy and Sandoz businesses were sold, or, like Ciba Specialty Chemicals, spun off as independent companies. The ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Reims, France
Reims ( , , ; also spelled Rheims in English) is the most populous city in the French department of Marne, and the 12th most populous city in France. The city lies northeast of Paris on the Vesle river, a tributary of the Aisne. Founded by the Gauls, Reims became a major city in the Roman Empire. Reims later played a prominent ceremonial role in French monarchical history as the traditional site of the coronation of the kings of France. The royal anointing was performed at the Cathedral of Reims, which housed the Holy Ampulla of chrism allegedly brought by a white dove at the baptism of Frankish king Clovis I in 496. For this reason, Reims is often referred to in French as ("the Coronation City"). Reims is recognized for the diversity of its heritage, ranging from Romanesque to Art-déco. Reims Cathedral, the adjacent Palace of Tau, and the Abbey of Saint-Remi were listed together as a UNESCO World Heritage Site in 1991 because of their outstanding Romanesque and Got ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
