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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. C ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Company
A company, abbreviated as co., is a Legal personality, legal entity representing an association of legal people, whether Natural person, natural, Juridical person, juridical or a mixture of both, with a specific objective. Company members share a common purpose and unite to achieve specific, declared goals. Over time, companies have evolved to have the following features: "separate legal personality, limited liability, transferable shares, investor ownership, and a managerial hierarchy". The company, as an entity, was created by the State (polity), state which granted the privilege of incorporation. Companies take various forms, such as: * voluntary associations, which may include nonprofit organizations * List of legal entity types by country, business entities, whose aim is to generate sales, revenue, and For-profit, profit * financial entities and banks * programs or educational institutions A company can be created as a legal person so that the company itself has limi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Mergers And Acquisitions
Mergers and acquisitions (M&A) are business transactions in which the ownership of a company, business organization, or one of their operating units is transferred to or consolidated with another entity. They may happen through direct absorption, a merger, a tender offer or a hostile takeover. As an aspect of strategic management, M&A can allow enterprises to grow or downsize, and change the nature of their business or competitive position. Technically, a is the legal consolidation of two business entities into one, whereas an occurs when one entity takes ownership of another entity's share capital, equity interests or assets. From a legal and financial point of view, both mergers and acquisitions generally result in the consolidation of assets and liabilities under one entity, and the distinction between the two is not always clear. Most countries require mergers and acquisitions to comply with antitrust or competition law. In the United States, for example, the Cl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Data Security
Data security or data protection 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- ... [...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 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] |
Samsung Biologics
Samsung Biologics Co., Ltd. is a global contract development and manufacturing organization headquartered in Songdo, Incheon, South Korea. The biotech division of Samsung Group, its core services range from late discovery to large-scale commercial manufacturing. The company focuses on monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, and mRNA vaccines. The company has partnered with pharmaceutical companies such as Pfizer, GlaxoSmithKline, Eli Lilly, AstraZeneca and Bristol-Myers Squibb. History Facilities & Expansion Founded in 2011, Samsung Biologics built four manufacturing plants with a capacity of more than 600,000 liters, from 2011 to 2023. In 2023, Samsung Biologics began construction of a fifth plant in Incheon, South Korea. The construction of Plant 5 is over 96% complete. The preliminary operational preparations have been completed, and full-scale operations are set to begin in April, with a gradual increase in facility utilizationce compl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States
The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic of 50 U.S. state, states and a federal capital district, Washington, D.C. The 48 contiguous states border Canada to the north and Mexico to the south, with the semi-exclave of Alaska in the northwest and the archipelago of Hawaii in the Pacific Ocean. The United States asserts sovereignty over five Territories of the United States, major island territories and United States Minor Outlying Islands, various uninhabited islands in Oceania and the Caribbean. It is a megadiverse country, with the world's List of countries and dependencies by area, third-largest land area and List of countries and dependencies by population, third-largest population, exceeding 340 million. Its three Metropolitan statistical areas by population, largest metropolitan areas are New York metropolitan area, New York, Greater Los Angeles, Los Angel ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
South Carolina
South Carolina ( ) is a U.S. state, state in the Southeastern United States, Southeastern region of the United States. It borders North Carolina to the north and northeast, the Atlantic Ocean to the southeast, and Georgia (U.S. state), Georgia to the west and south across the Savannah River. Along with North Carolina, it makes up the Carolinas region of the East Coast of the United States, East Coast. South Carolina is the List of U.S. states and territories by area, 11th-smallest and List of U.S. states and territories by population, 23rd-most populous U.S. state with a recorded population of 5,118,425 according to the 2020 United States census, 2020 census. In , its GDP was $213.45 billion. South Carolina is composed of List of counties in South Carolina, 46 counties. The capital is Columbia, South Carolina, Columbia with a population of 136,632 in 2020; while its List of municipalities in South Carolina, most populous city is Charleston, South Carolina, Charleston with ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
GlaxoSmithKline
GSK plc (an acronym from its former name GlaxoSmithKline plc) is a British Multinational corporation, multinational Pharmaceutics, pharmaceutical and biotechnology company with headquarters in London. It was established in 2000 by a Mergers and acquisitions, merger of Glaxo Wellcome and SmithKline Beecham, which was itself a merger of a number of pharmaceutical companies around the Smith, Kline & French firm. GSK is the tenth largest pharmaceutical company and No. 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 & Co., Merck Sharp & Dohme. The company has a primary listing on the London Stock Exchange and is a constituent of the FTSE 100 Index. As of February 2024, it had a Market capitalization, market capitalisation of £69 billion, the eighth largest on the London Stock Exchange. The company developed ... [...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 the 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-M ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Novartis
Novartis AG is a Swiss multinational corporation, multinational pharmaceutical company, pharmaceutical corporation based in Basel, Switzerland. Novartis is one of the largest pharmaceutical companies in the world and was the eighth largest by revenue in 2024. 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; produced by Sandoz since 2023), terbinafine (Lamisil), deferasirox (Exjade), and others. Novartis was formed in 1996 by the merger of Ciba-Geigy and Sandoz. It was considered the largest corporate merger in history during that time. The pharmaceutical and agrochemical divisions of both companies formed Novartis as an independent entity. The name Novartis was based on the Latin terms, ''novae artes'' (new skills). After the merger, other Ciba-Geigy and ... [...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] |
